Title of Invention	AN UNIQUE COMBINATION OF AYURVEDIC COMPOUNDS FOR CORRECTING A RARE FORM OF MULLERIAN DYSGENESIS
Abstract	Abstract An unique combination of ayurvedic compounds has corrected and developed a rudimentary uterus, to become a normal uterus, both physically and functionally. Rudimentary uterus, a rare variety of Mullerian Digenesis, is an inert form, which does not respond to hormonal or physical stimuli. From the development of the stunted uterus, in a phased manner, as shown by the serial scans, one surmises, genetic stimulation has taken place and further studies may help in identifying the Mullerian Gene. This is a global problem. This is the first record of correction of a birth defect. Recognition and Use of ayurvedic compounds is the first basic step. Subsequent modification, on seeing response, into eight phases is the next step and serial scans, to monitor effectiveness sets the seal of approval. The stimulation, by combined and cumulative effect of ayurvedic compounds, is the core inventive step.

Title of Invention

AN UNIQUE COMBINATION OF AYURVEDIC COMPOUNDS FOR CORRECTING A RARE FORM OF MULLERIAN DYSGENESIS

Abstract

Abstract An unique combination of ayurvedic compounds has corrected and developed a rudimentary uterus, to become a normal uterus, both physically and functionally. Rudimentary uterus, a rare variety of Mullerian Digenesis, is an inert form, which does not respond to hormonal or physical stimuli. From the development of the stunted uterus, in a phased manner, as shown by the serial scans, one surmises, genetic stimulation has taken place and further studies may help in identifying the Mullerian Gene. This is a global problem. This is the first record of correction of a birth defect. Recognition and Use of ayurvedic compounds is the first basic step. Subsequent modification, on seeing response, into eight phases is the next step and serial scans, to monitor effectiveness sets the seal of approval. The stimulation, by combined and cumulative effect of ayurvedic compounds, is the core inventive step.

Full Text	The essence of the invention is that the use of an unique combination of 11 Ayurvedic Compounds in 8 phases has resulted in the correction of a rudimentary uterus (inert) and it has grown to near normal size and has exhibited functional changes also. The unique combination, as an art, is a pioneering one and therefore, absence of prior art, itself, is proof of its originality. Summary 1. Rudimentary uterus (or vestigial uterus) is a rare form of MuUerian Dysgenesis, which has an incidence of nearly 1 %. 2. Rudimentary uterus rarely undergo any change in life. 3. It is a birth defect, not a disease. Hence only correction and not cure can be attempted. 4. Mullerian Gene is yet to be identified. 5. Genetic drive is currently considered as the cause of puberty changes. 6. Non-therapeutic administration of 11 Ayurvedic Compounds in 8 phases has resulted in the growth of this rudimentary uterus on normal lines to near normal size and it has manifested functional changes also. 7. These Ayurvedic Compounds have been therapeutically used for more than 1000 years for many conditions in man, woman and child. This is the first time they have been used in an unique combination to correct a birth defect 8. The duration of the 8 phases of Ayurvedic Compounds is for a total of not less than 32 months. The combined and cumulative effect of these compounds have stimulated genetic drive and made this inert rudimentary uterus evolve on normal lines 9. No medical correction in any system of medicine is available for this global problem. This is the first viable option 10. This breakthrough will herald new management options for birth defects. Introduction Birth defects are galore in clinical practice and one such condition is Mullerian Digenesis. Before we go to that, a few words about normal development of uterus or Eugene sis. Eugene sis Mullerian Ducts are responsible for the development of the generative tract in the female (ref. chart 1. Mullerian Structures on page 16). Normally, the two ducts fuse in the human embryo and their subsequent canalization and hypertrophy result in die formation of the female reproductive tract, consisting of tubes, uterus (corpus and cervix) and vagina (major portion). Normally the non-fused ducts become the tubes, the fused one, on canalization from below upwards, become vagina, cervix and corpus of uterus and the uterus in turn has a muscular coat (myometrium), a lining layer (endometrial) and a cavity (endometrial cavity) and this process is over by twenty weeks of gestation, the lower most part of the vagina is derived from the uro-genital sinus. Embryological steps in the formation of the female genital tract. 1. Mullerian ducts grow towards each other and fuse in the midline to form -utero-vaginal prim odium. The non-fused cranial part of each Mullerian duct give rise to the uterine tubes. The uteri-vaginal prim odium gives rise to uterine corpus, uterine cervix and the major portion of the upper vagina especially the fibro muscular coat. 2. Formation of cavity and lining. The formation of cavity is from below upwards (vagina, cervical canal and endometrial cavity). 3. Formation of cervix and corpus. 4. At first cervix is bigger than corpus (infantile uterus). 5. Next corpus grows fast and the ratio of cervix to corpus becomes 1 : 2 (compare with Serial USG. Chart on page 22). About 20% of female babies have bleeding per valium in the first few days of life. This is because of maternal sex hormones circulating in the newborn's blood. Normally girls beg to menstruate between the ages of 10 and 14. Physical development and hormonal production were considered the cause for this onset. Now, genetic drive is considered as the cause and as proof of this, we find girls Mullerian Digenesis (incidence 1%) - is the term used for a birth defect wherein there is mal-development, while in utero, resulting in a spectrum of forms starting from rudimentary uterus (rare), hypoplastic uterus (where structural development has taken place and there is minimal function also) and the remaining numerous forms (e.g. Unicom ate, bicomuate, septet, subspace, actuate, double uterus, double cervix, double vagina and uterus didelphys etc.) though showing structural abnormality are functionally normal and go through life normally (menstruation, pregnancy etc.). The rudimentary one is usually a stationary one (a rare variety which rarely manifests any change) and remains as such throughout life. This rudimentary tissue is (ref. scan No.l Serial USG. Chart on Page 22) devoid of the normal layers and cavity and it will be non-responsive to hormones. Hence, at best, only an attempt can be made to correct it. It is this inert tissue, which has grown (ref. chart 1 Mullerian structures on page 16 and Drawing Mol on page 18), on the administration of Ayurvedic Compounds (List of Ayurvedic Compounds with text and dosage page 19) as well as formulary (page 9-15) probably due to stimulation of the genetic drive. In this case, initially, there was no cavity (end organ non-existence) and therefore, (though the H.P.O. Axis was normal) no bleeding occurred. Later, when the cavity and endometrial lining development and since there was no end organ resistance, she had bleeding. No known method is available to correct the birth defect. Hence this method of correction will prove to be a breakthrough in the management of birth defects. Drugs :- Medicinal Drags have two functions. (1) Therapeutic - therapy or treatment of diseases, where drags are given to combat and conquer disease. (2) Non-Therapeutic - Drags are given to those who do not belong to category (1), to supplement body resources, so that the vim, vigor and vitality of the individual is maintained. This category includes (a) Vegetarians - Their diet lack one or more essential amino-acids, as vegetable Proteins are biologically incomplete. This holds trae even for fat Soluble vitamins such as A and D and as well as water soluble, such as B 12, which are essentially animal based and supplementation becomes mandatory. (b) Elderly - Prone for deficiency of vitamins and minerals, resulting in low bone density. The combination of amino-acids, vitamins and minerals can offset the deficiency and contribute to physical wellbeing. (c) Pre-menopausal and Post Menopausal Women - Due to deficient intake of dietary calcium and vitamin D. Supplementation of these along with an anti-osteoporosis agent has a beneficial effect. (d) Pregnancy & Lactation - A physiological process, wherein there is a high risk of nutritional deficiency. (e) Stress & Convalescence - Every process in the body is associated with number of interlinked processes. Modem life is full of stress. Nutritional supplementation becomes the cornerstone of management. (f) Congenital Anomaly or Birth Defect - Nature has come to a standstill. Smce this is not a disease but a defect, at least, non-therapeutic drags may be given to correct the problem. At present there is no method of correction - of improving or developing - the rudimentary uterus which is a global problem. Luckily for us, this unique combination of Ayurvedic drags, has shown that it not only increases well-being but also stimulates the rudimentary uterus to grow. Phases (Correction) In this invention to overcome the stunted growth, an unique combination of ayurvedic compounds (Asoka Ghritam, Kalyanaka Ghritam, Aswagandhadi Lehyam, Rajapravarthana Vati, Kulatthadi Kashayam, Varanadi Kashayam, Bala Thailam, Chandraprabha Vati, Phalasarpis, Pushing Choom am Tablet and Asoka Arishtam) in 8 phases (ref. phases of correction, page 21 ) were used, as a correction procedure. They produced growth and differentiation of uterus and canalization of both endometrial cavity and cervical. The lining of the endometrial cavity became responsive to hormones and she has had two periods. It is evident that the compounds have acted in a combined and cumulative manner to produce these changes. Results - ( Ref chart 2 , Serial USG.Chart page 23, Birth Defect - growth towards normalcy - genetic drive chart on page 22.) Providentially she went to an Integrated Medical Doctor (one who had undergone conjoint study of Allopathy and Ayurveda ) who (1) also diagnosed rudimentary uterus (based on scan) (2) but did a diagnostic laparoscopy and confirmed the diagnosis (by the presence of tubes') (3) gave Ayurvedic compounds (probably by divine guidance) as a non-therapeutic measure (4) took serial scans to provide clinching evidence of growth and progress The rudimentary uterus has grown three dimensionally to become a hypoplastic, intenerated (normal position) uterus, having myometrium, endometrial and a cavity. The serial scans has also shown that the hypothalamus-pituitary-ovarian axis ( H.P.O.Axis) is normal as she has ovulated from both ovaries. The cervico-coiporeal ratio has become nearly normal (normal 1 : 2, in this case 1 : 1.9 ). There is no report of an such case in medical history earlier. The explanation for these changes - could be (1) chance - scientifically not acceptable (2) miracle - supernatural event - usually non-repetitive (3) An extreme case of M.I.H. getting over at 16 years (exceptional) or Ayurvedic compounds acting on (a) the Mullerian gene - stimulation of the genetic drive (b) on the Mullerian tissue and (c) by canceling M.I.H. ( Mullerian Inhibiting Factor ). (4) Ayurvedic compounds acting on (a) the Mullerian gene - stimulation of the genetic drive (b) on the Mullerian tissue and (c) by canceling M.I.H. (Mullerian inhibiting Factor). Note : In some, M.I.H. persists from 4-13 years and usually disappears by the age of 13 years. During this time, there is loss of growth and after disappearance of M.I.H., normal growth takes place. DISCUSSION The serial U.S.G. Charts (Page 22) provide the clinching evidence of progress. The first scan in 1994 did not show a uterus, but only a rudimentary tissue, which lacked a cavity and lacked differentiation into myometrium and endometrial and also lacked differentiation into cervix and corpus (there was therefore no ratio between cervix and corpus) and in addition was inert (not responsive to hormones) as it lacked endometrial. Even the diagnosis of rudimentary uterus was confirmed only by diagnostic laparoscopy on finding the tubes arising from the upper and lateral aspects of the rudimentary tissue. 03-07-2002 distinct cervix noted-cervico-corporeal ratio was 1 : 0.5 (infantile uterus) 30-07-2002 do do do do do do do.l: 0/82 01-02-2003 do do do do do do do.l : 1.5 17-08-2006 do do do do do do do.l : 1.9 (normal 1 :2) Finally, the two periods are evidence that the newly formed endometrial is responsive to hormones. The impact of this invention and the spectacular progress (hitherto unheard of) would be viewed by (a) the devout - as a divine dispensation. (b) the scientist - as an expression of the persevering scientific spirit against odds and as a welcome sign that the identification of the mullein gene, gene therapy, isolation of plant principles and the management of other forms of birth defect is just around the comer. (c) the woman having a rudimentary uterus - as a ray of hope and sunshine in life's tunnel of darkness. State of the Art of the subject - no medical option The work already done in this area- elsewhere - nil in India - Correction of Mullerian Digenesis after relevant investigation is being conducted from 1-4-2005 at A.G. Crumpet P.H. & Maternity Centre, No.2, Bharathi Street, Radha Nagar, Chromepet, Chennai - 600 044, Phone : 22655503 Ayurvedic Compounds Ayurvedic Compounds are normally named based on the main drug - thus we have Atoka Ghritham wherein Asoka is the main ingredient; similarly Asana -Balladic Thailam wherein Asana and Bylaw are the main ingredients. At times the name of the individual who found out the formulary is mentioned such as Chyavanaprash Lehyam. There are many compounds having the same name but having different formulary and their indications may also vary. Hence the list of Ayurvedic Compounds mentions the text or origin so that no mistake should take place during administration. In this non-therapeutic process 11 distinct Ayurvedic Compounds (grahams, lehyams kashyams etc.) are given together, not in a mixture, but in 8 phases to a total of minimum 32 months and more to achieve a beneficial change in the rudimentary structure. They are given at different timings during the day depending on the phase. Phases may be advanced, depending on response. Ayurvedic drugs are available all over the country. Drug firms usually mention the text from which the compound's formulary was taken and the dosage. Drug firms normally provide, both drug formulary as well as therapeutic index. Merely verifying the name of the drug is not enough. One must make sure it is from the text referred to in the drug list (unlike Allopathic medicine). There are drugs with the same name, but from different text books and their indications may be different. Hence care taken to prevent mistakes. These ayurvedic drugs have been used for more than 1000 years for the treatment ( therapy) of various conditions in man, woman and child and as per the indications of the respective compounds. All of them are not specific for uterine problems. They have always been used therapeutically as per indications. This is probably the first time , they have been used in an unique combination as the problem is not a disease., but a birth defect for more than 32 months. For the patient, the ayurvedic drugs were obtained from IMPCOPS (Indian Medical Practitioner's Cooperative Pharmacy and Stores ) 34-37 Kalki Krishnamurthy Salai, Thiruvanmiyur, Chennai - 41. Vaidya Yoga Ratnavali (English) is their drug formulary. IMPCOPS was started m 1944 and is having branches in all the southern states. Drugs not available with IMPCOPS were obtained from Arya Vaidya Pharmacy, 279 (old 119 ), Purusawalkam High Road, Kelly’s, Chennai. 10. Arya Vaidya Pharmacy has its manufacturing unit, Arya Vaidya Nilayam, at Madurai. The list of the 11 Ayurvedic Compounds is enclosed on page 20. The Ayurvedic Compounds (ghees,lehyas, kashayams etc.) were given, initially singly and subsequently in combination. Of the 11 compounds (a) grahams -3 (1,3,10), aristae - 1 (2), (c) {ehyam - 1 (4), (d) vati - 2 (5,9), (e) kashayam - 2 (6,7), (f) thailam -1 (8) and (g) choom am tablet - 1 (11). (a) Ghrithams - are medicated ghee preparations, which contain the fat soluble medicmal principle of the drugs used in a particular preparation. (b) Arishtam - are alcoholic medicaments, which are prepared by allowing the juices Or decoctions of raw drugs mixed with sugars to undergo fermentation. They are mixed with an equal volume of water before taking i.e. given in 1 : 1 dilution. (c) Lehyams - are linctuses or confections or sweetened extracts equivalent to confections, electuaries and conserves of British Pharmacopiae. (d) Vati - are pills or tablets. (e) Kashayams - are devotions made from coarse powders, given in 1 : 4 dilution. (f) Thailams - are medicated oils. (g) Choomam Tablets - are fine, dry powders of drugs. Choomam Tablets are made by the help of tablet making machines. Some suitable adhesive and disintegrants are used to facilitate tablet pressing. Formulary of Ayurvedic Compounds with botanical names are given below. Oroxylum indicum Vent 37. Shorea robulsta Gaertn. 38. Pinus roxburghii Sargent 39. Cyperus rotundus Linn. 40. Sida rhombifolia 41. Cyperus rotundus Linn. 42. Gmelina asiatica Linn. 43. Nardostachys jatamansi DC 44. Randia dumetorum Lirm. 45. Kaemferia galanga Linn. 46. Teramnus labialis Spreng. 47. Phaseolus trilobus Ait. 48. Inula racemoses Hook F 49. Cinnamomum zeylanicum 50. Syzygium aromaticura Merr. 51. Parmelia ( Sange jaranath ) 52. Crocus sativus Linn. 53. Cinnamomum camphora Social Relevance: - The maternal instinct is one of the strongest in the human female. Any woman, bom with a rudimentary uterus, given the choice, would accept the non-therapeutic administration in the hope of achieving womanhood and subsequently motherhood. The incidence of Mullerian Dysgenesis is just below 1 %. In a country like India, having half a billion women, the number of women having this defect is, to say the least, very large. Clinical Identification : ■f (a) Scanning (ultra-sonography) to spot the condition only. (1) During neonatal period - neonatal scanning of the genitor-urinary system of all female babies, who do not have vaginal bleeding in the first week of life. (2) Between 16 and 18 years - this would reveal the rudimentary uterus and has to be confirmed by a diagnostic laparoscopy. (by the presence of tubes) (b) Astrology - An aphorism in astrology states " when the seventh house or Navamsa. occupied by the seventh lord, be owned by the Sun, Mars or Saturn, without benefic aspects, her womb is likely to be defective ".In this case, Rasi chart shows Mars deposited in seventh house, which is its own house, (along with Venus) and Moon is posited in the Ascendent. Navamsa chart shows the seventh lord, Mars, as occupant of the house of Venus - (Rasi Ascendant). (c) Palmar Dermatoglyphics - an avenue which needs to be explored. In this invention, to overcome the stunted growth, the 11 Ayurvedic Compounds mentioned were given. They produced Differentiation, Growth (Hypertrophy) of uterus and Canalisation of both endometrial cavity and cervical canal. The Lining of the endometrial cavity became responsive to hormones and she has had two periods. It is evident that the totality of cumulative and combined effects (akin to synergism, which is usually manifested in short duration) of the different, distinct, known 11 Ayurvedic Compounds, given during the 8 phases (minimum duration - 32 months) has caused the growth of the rudimentary uterus and the uterus has become functional (patient has had two periods). Proof of growth has been confirmed by serial scans and the latest dimensions ofthe uterus are 5.8 cms. X 2cms. X 3 cms. Brief Description - Drawings (No.l ), List Phases, Charts (No. 1 & 2). Page 18 - drawing No. 1 - Figure on left shows above frontal view and below side view and in each (1) tube, (2) rudimentary uterus - no cavity, no differentiation and (3) vaginal. Figure on right shows the same features of the near normal sized uterus having cavity and differentiation into cervix and corpus. Page 19 - List of Ayurvedic Compounds with text and dosage. In Ayurveda, names of compounds depend upon the main ingredient. There are many compounds with the same name, depending upon text, from which the formulary has been taken. Page 20 - Phases of Correction Page 21 - Birth Defect - growth towards normalcy - ? Genetic Drive. - A comparative chart highlighting the changes from 1994 to 2006. Page 22 - Serial USG Charts showing developmental changes - The chart shows ten USG scans of which two are follicular scans - 3/7/02 & 30/7/02 showing ovulation (1) from R. Ovary (2) from L. Ovary (proving that the HPOAxis is functional in both ovaries) and die remaining are pelvic scans. These scans show the developmental changes from scan 1 -rudimentary uterus to near normal uterus in scan 10. The scan on 3/7/02 showed a distinct cervix and the normal differentiation of uterus into corpus and cervix has taken place. Page 23 Claims Page 24 Abstract I claim 1. An unique combination for correcting a natural defect of a rare form of Mullerian Digenesis - rudimentary uterus - comprising l.Asoka Ghritham (AG), 2.Kalyanaka Ghritham (KG), S.Aswagandhadi Lehyam (AGL), 4. Rajapravavarthana Vati (RPV) , S.Kulatthadi Kashayam (KK), 6.Bala Thailam (BT), 7.Varanadi Kashayam (VK), S.Chandraprabha Vati (CPV),9. Pushing Choomam Tablet (PCT), 10. Asoka Arishtam (AA) and 1 l.Phalasarpis(PS). 2. An unique combination, as claimed in Claim 1 , wherein Asoka Ghritham(AG) is used Individually in definite time interval. 3. An unique combination, as claimed in Claim 2, wherein the tune interval ranges from two months to nine months. 4. An unique combination, as in the preceding claim, wherein, during the definite time interval, the said ayurvedic ingredients is used daily. 5. An unique combination, as in the preceding claim, wherein, some of the ayurvedic ingredients are used in a combined manner. 6.An unique combination as claimed in clai m1 ,wherein, Kalyanaka Ghritham (KG) and Aswagandhadi Lehyam(AGL) are used for four months on a daily basis. 7. An unique combination as claimed in claim 1, wherein, Kalyanaka Ghritham (KG), Aswagandhadi Lehyam (AGL), Rajapravarthana Vati (RPV) and Kulatthadi Kashayam (KK) for three months on a daily basis. 8.An unique combination, as claimed in claim 1, wherein, Kalyanaka Ghritham (KG), Aswagandhadi Lehyam (AGL), Rajapravarthana Vati (RPV) ,Kulatthadi Kashayam(KK) with local application of Bala Thailam(BT), for five months, on a daily basis. 9. An unique combination, as claimed in Claim 1, wherein, Kalyanaka Ghritham (KG), Aswagandhadi Lehyam (AGL) , Rajapravarthana Vati (RPV) ,Kulatthadi Kashayam(KK), Bala Thailam(BT) and in addition Varanadi Kashayam(VK), for two months on a daily basis. 10. An unique combination, as claimed in claim 1 , wherein Kalyanaka Ghritham (KG), Aswagandhadi Lehyam (AGL) , Rajapravarthana Vati (RPV) ,Kulatthadi Kashayam(KK), Bala Thailam(BT), Varanadi Kashayam(VK), and Chandraprabha Vati (CPV) for four months on a daily basis. 11 .An unique combination, as claimed in claim 1 , wherein Kalyanaka Ghritham (KG), Aswagandhadi Lehyam (AGL), Rajapravarthana Vati (RPV) ,Kulatthadi Kashayam(KK), Bala Thailam(BT), Varanadi Kashayam(VK), Chandraprabha Vati (CPV) and at this step Pushing Choomam tablet (PCT) added, for nine months on a daily basis. 12.An unique combination, as claimed in claim 1 , wherein, Kalyanaka Ghritham (KG), Aswagandhadi Lehyam (AGL) , Rajapravarthana Vati (RPV) ,Kulatthadi Kashayam(KK), Bala Thailam(BT), Varanadi Kashayam(VK), Chandraprabha Vati (CPV) ,Pushing Choomam tablet (PCT) and Asoka Ghritham (AA) used thereafter , on a daily basis. 13.An unique combination, as claimed in the preceding claims, wherein , all the ayurvedic ingredients are used, as herein described, and shown in accompanying charts and drawing as evidence.

Full Text

The essence of the invention is that the use of an unique combination of 11 Ayurvedic Compounds in 8 phases has resulted in the correction of a rudimentary uterus (inert) and it has grown to near normal size and has exhibited functional changes also.
The unique combination, as an art, is a pioneering one and therefore, absence of prior art, itself, is proof of its originality. Summary
1. Rudimentary uterus (or vestigial uterus) is a rare form of MuUerian Dysgenesis, which has an incidence of nearly 1 %.
2. Rudimentary uterus rarely undergo any change in life.
3. It is a birth defect, not a disease. Hence only correction and not cure can be attempted.
4. Mullerian Gene is yet to be identified.
5. Genetic drive is currently considered as the cause of puberty changes.
6. Non-therapeutic administration of 11 Ayurvedic Compounds in 8 phases has resulted in the growth of this rudimentary uterus on normal lines to near normal size and it has manifested functional changes also.
7. These Ayurvedic Compounds have been therapeutically used for more than 1000 years for many conditions in man, woman and child. This is the first time they have been used in an unique combination to correct a birth defect
8. The duration of the 8 phases of Ayurvedic Compounds is for a total of not less than 32 months. The combined and cumulative effect of these compounds have stimulated genetic drive and made this inert rudimentary uterus evolve on normal lines
9. No medical correction in any system of medicine is available for this global problem. This is the first viable option
10. This breakthrough will herald new management options for birth defects.

Introduction
Birth defects are galore in clinical practice and one such condition is Mullerian Digenesis. Before we go to that, a few words about normal development of uterus or Eugene sis.
Eugene sis
Mullerian Ducts are responsible for the development of the generative tract in the female (ref. chart 1. Mullerian Structures on page 16). Normally, the two ducts fuse in the human embryo and their subsequent canalization and hypertrophy result in die formation of the female reproductive tract, consisting of tubes, uterus (corpus and cervix) and vagina (major portion). Normally the non-fused ducts become the tubes, the fused one, on canalization from below upwards, become vagina, cervix and corpus of uterus and the uterus in turn has a muscular coat (myometrium), a lining layer (endometrial) and a cavity (endometrial cavity) and this process is over by twenty weeks of gestation, the lower most part of the vagina is derived from the uro-genital sinus.
Embryological steps in the formation of the female genital tract.
1. Mullerian ducts grow towards each other and fuse in the midline to form -utero-vaginal prim odium. The non-fused cranial part of each Mullerian duct give rise to the uterine tubes. The uteri-vaginal prim odium gives rise to uterine corpus, uterine cervix and the major portion of the upper vagina especially the fibro muscular coat.
2. Formation of cavity and lining. The formation of cavity is from below upwards (vagina, cervical canal and endometrial cavity).
3. Formation of cervix and corpus.
4. At first cervix is bigger than corpus (infantile uterus).
5. Next corpus grows fast and the ratio of cervix to corpus becomes 1 : 2 (compare with Serial USG. Chart on page 22).

About 20% of female babies have bleeding per valium in the first few days of life. This is because of maternal sex hormones circulating in the newborn's blood. Normally girls beg to menstruate between the ages of 10 and 14. Physical development and hormonal production were considered the cause for this onset. Now, genetic drive is considered as the cause and as proof of this, we find girls Mullerian Digenesis (incidence 1%) - is the term used for a birth defect wherein there is mal-development, while in utero, resulting in a spectrum of forms starting from rudimentary uterus (rare), hypoplastic uterus (where structural development has taken place and there is minimal function also) and the remaining numerous forms (e.g. Unicom ate, bicomuate, septet, subspace, actuate, double uterus, double cervix, double vagina and uterus didelphys etc.) though showing structural abnormality are functionally normal and go through life normally (menstruation, pregnancy etc.). The rudimentary one is usually a stationary one (a rare variety which rarely manifests any change) and remains as such throughout life. This rudimentary tissue is (ref. scan No.l Serial USG. Chart on Page 22) devoid of the normal layers and cavity and it will be non-responsive to hormones. Hence, at best, only an attempt can be made to correct it. It is this inert tissue, which has grown (ref. chart 1 Mullerian structures on page 16 and Drawing Mol on page 18), on the administration of Ayurvedic Compounds (List of Ayurvedic Compounds with text and dosage page 19) as well as formulary (page 9-15) probably due to stimulation of the genetic drive. In this case, initially, there was no cavity (end organ non-existence) and therefore, (though the H.P.O. Axis was normal) no bleeding occurred. Later, when the cavity and endometrial lining development and since there was no end organ resistance, she had bleeding. No known method is available to correct the birth defect. Hence this method of correction will prove to be a breakthrough in the management of birth defects.

Drugs :- Medicinal Drags have two functions.
(1) Therapeutic -
therapy or treatment of diseases, where drags are given to combat and conquer disease.
(2) Non-Therapeutic -
Drags are given to those who do not belong to category (1), to supplement body resources, so that the vim, vigor and vitality of the individual is maintained. This category includes
(a) Vegetarians -
Their diet lack one or more essential amino-acids, as vegetable Proteins are biologically incomplete. This holds trae even for fat Soluble vitamins such as A and D and as well as water soluble, such as B 12, which are essentially animal based and supplementation becomes mandatory.
(b) Elderly -
Prone for deficiency of vitamins and minerals, resulting in low bone density. The combination of amino-acids, vitamins and minerals can offset the deficiency and contribute to physical wellbeing.
(c) Pre-menopausal and Post Menopausal Women -
Due to deficient intake of dietary calcium and vitamin D. Supplementation of these along with an anti-osteoporosis agent has a beneficial effect.
(d) Pregnancy & Lactation -
A physiological process, wherein there is a high risk of nutritional deficiency.
(e) Stress & Convalescence -
Every process in the body is associated with number of interlinked processes. Modem life is full of stress. Nutritional supplementation becomes the cornerstone of management.
(f) Congenital Anomaly or Birth Defect -
Nature has come to a standstill. Smce this is not a disease but a defect, at least, non-therapeutic drags may be given to correct the problem. At present there is no method of correction - of improving or developing - the rudimentary uterus which is a global problem. Luckily for us, this unique combination of Ayurvedic drags, has shown that it not only increases well-being but also stimulates the rudimentary uterus to grow.

Phases (Correction)
In this invention to overcome the stunted growth, an unique combination of ayurvedic compounds (Asoka Ghritam, Kalyanaka Ghritam, Aswagandhadi Lehyam, Rajapravarthana Vati, Kulatthadi Kashayam, Varanadi Kashayam, Bala Thailam, Chandraprabha Vati, Phalasarpis, Pushing Choom am Tablet and Asoka Arishtam) in 8 phases (ref. phases of correction, page 21 ) were used, as a correction procedure. They produced growth and differentiation of uterus and canalization of both endometrial cavity and cervical. The lining of the endometrial cavity became responsive to hormones and she has had two periods. It is evident that the compounds have acted in a combined and cumulative manner to produce these changes. Results -
( Ref chart 2 , Serial USG.Chart page 23, Birth Defect - growth towards normalcy - genetic drive chart on page 22.) Providentially she went to an Integrated Medical Doctor (one who had undergone conjoint study of Allopathy and Ayurveda ) who
(1) also diagnosed rudimentary uterus (based on scan)
(2) but did a diagnostic laparoscopy and confirmed the diagnosis (by the presence of tubes')

(3) gave Ayurvedic compounds (probably by divine guidance) as a non-therapeutic measure
(4) took serial scans to provide clinching evidence of growth and progress
The rudimentary uterus has grown three dimensionally to become a hypoplastic, intenerated (normal position) uterus, having myometrium, endometrial and a cavity. The serial scans has also shown that the hypothalamus-pituitary-ovarian axis ( H.P.O.Axis) is normal as she has ovulated from both ovaries. The cervico-coiporeal ratio has become nearly normal (normal 1 : 2, in this case 1 : 1.9 ). There is no report of an such case in medical history earlier.
The explanation for these changes - could be
(1) chance - scientifically not acceptable
(2) miracle - supernatural event - usually non-repetitive
(3) An extreme case of M.I.H. getting over at 16 years (exceptional) or
Ayurvedic compounds acting on
(a) the Mullerian gene - stimulation of the genetic drive
(b) on the Mullerian tissue and
(c) by canceling M.I.H. ( Mullerian Inhibiting Factor ).

(4) Ayurvedic compounds acting on
(a) the Mullerian gene - stimulation of the genetic drive
(b) on the Mullerian tissue and
(c) by canceling M.I.H. (Mullerian inhibiting Factor).
Note : In some, M.I.H. persists from 4-13 years and usually disappears by the age of 13 years. During this time, there is loss of growth and after disappearance of M.I.H., normal growth takes place.
DISCUSSION
The serial U.S.G. Charts (Page 22) provide the clinching evidence of progress. The first scan in 1994 did not show a uterus, but only a rudimentary tissue, which lacked a cavity and lacked differentiation into myometrium and endometrial and also lacked differentiation into cervix and corpus (there was therefore no ratio between cervix and corpus) and in addition was inert (not responsive to hormones) as it lacked endometrial. Even the diagnosis of rudimentary uterus was confirmed only by diagnostic laparoscopy on finding the tubes arising from the upper and lateral aspects of the rudimentary tissue.
03-07-2002 distinct cervix noted-cervico-corporeal ratio was 1 : 0.5 (infantile uterus)
30-07-2002 do do do do do do do.l: 0/82
01-02-2003 do do do do do do do.l : 1.5
17-08-2006 do do do do do do do.l : 1.9 (normal 1 :2)
Finally, the two periods are evidence that the newly formed endometrial is responsive to hormones.
The impact of this invention and the spectacular progress (hitherto unheard of) would be viewed by
(a) the devout - as a divine dispensation.
(b) the scientist - as an expression of the persevering scientific spirit against odds and as a welcome sign that the identification of the mullein gene, gene therapy, isolation of plant principles and the management of other forms of birth defect is just around the comer.
(c) the woman having a rudimentary uterus -
as a ray of hope and sunshine in life's tunnel of darkness.

State of the Art of the subject - no medical option
The work already done in this area- elsewhere - nil
in India - Correction of Mullerian Digenesis after relevant investigation is being conducted from 1-4-2005 at A.G. Crumpet P.H. & Maternity Centre, No.2, Bharathi Street, Radha Nagar, Chromepet, Chennai - 600 044, Phone : 22655503
Ayurvedic Compounds
Ayurvedic Compounds are normally named based on the main drug - thus we have Atoka Ghritham wherein Asoka is the main ingredient; similarly Asana -Balladic Thailam wherein Asana and Bylaw are the main ingredients. At times the name of the individual who found out the formulary is mentioned such as Chyavanaprash Lehyam. There are many compounds having the same name but having different formulary and their indications may also vary. Hence the list of Ayurvedic Compounds mentions the text or origin so that no mistake should take place during administration. In this non-therapeutic process 11 distinct Ayurvedic Compounds (grahams, lehyams kashyams etc.) are given together, not in a mixture, but in 8 phases to a total of minimum 32 months and more to achieve a beneficial change in the rudimentary structure. They are given at different timings during the day depending on the phase. Phases may be advanced, depending on response.
Ayurvedic drugs are available all over the country. Drug firms usually mention the text from which the compound's formulary was taken and the dosage. Drug firms normally provide, both drug formulary as well as therapeutic index. Merely verifying the name of the drug is not enough. One must make sure it is from the text referred to in the drug list (unlike Allopathic medicine). There are drugs with the same name, but from different text books and their indications may be different. Hence care taken to prevent mistakes.

These ayurvedic drugs have been used for more than 1000 years for the treatment ( therapy) of various conditions in man, woman and child and as per the indications of the respective compounds. All of them are not specific for uterine problems. They have always been used therapeutically as per indications. This is probably the first time , they have been used in an unique combination as the problem is not a disease., but a birth defect for more than 32 months.
For the patient, the ayurvedic drugs were obtained from IMPCOPS (Indian Medical Practitioner's Cooperative Pharmacy and Stores ) 34-37 Kalki Krishnamurthy Salai, Thiruvanmiyur, Chennai - 41. Vaidya Yoga Ratnavali (English) is their drug formulary. IMPCOPS was started m 1944 and is having branches in all the southern states. Drugs not available with IMPCOPS were obtained from Arya Vaidya Pharmacy, 279 (old 119 ), Purusawalkam High Road, Kelly’s, Chennai. 10. Arya Vaidya Pharmacy has its manufacturing unit, Arya Vaidya Nilayam, at Madurai.
The list of the 11 Ayurvedic Compounds is enclosed on page 20. The Ayurvedic Compounds (ghees,lehyas, kashayams etc.) were given, initially singly and subsequently in combination. Of the 11 compounds (a) grahams -3 (1,3,10),

aristae - 1 (2), (c) {ehyam - 1 (4), (d) vati - 2 (5,9), (e) kashayam - 2 (6,7), (f) thailam -1 (8) and (g) choom am tablet - 1 (11).
(a) Ghrithams - are medicated ghee preparations, which contain the fat soluble
medicmal principle of the drugs used in a particular preparation.
(b) Arishtam - are alcoholic medicaments, which are prepared by allowing the juices
Or decoctions of raw drugs mixed with sugars to undergo fermentation. They are
mixed with an equal volume of water before taking i.e. given in 1 : 1 dilution.
(c) Lehyams - are linctuses or confections or sweetened extracts equivalent to
confections, electuaries and conserves of British Pharmacopiae.
(d) Vati - are pills or tablets.
(e) Kashayams - are devotions made from coarse powders, given in 1 : 4 dilution.
(f) Thailams - are medicated oils.
(g) Choomam Tablets - are fine, dry powders of drugs. Choomam Tablets are made by the help of tablet making machines. Some suitable adhesive and disintegrants are used to facilitate tablet pressing.
Formulary of Ayurvedic Compounds with botanical names are given below.

Oroxylum indicum Vent
37. Shorea robulsta Gaertn.
38. Pinus roxburghii Sargent
39. Cyperus rotundus Linn.
40. Sida rhombifolia
41. Cyperus rotundus Linn.
42. Gmelina asiatica Linn.
43. Nardostachys jatamansi DC
44. Randia dumetorum Lirm.
45. Kaemferia galanga Linn.
46. Teramnus labialis Spreng.
47. Phaseolus trilobus Ait.
48. Inula racemoses Hook F
49. Cinnamomum zeylanicum
50. Syzygium aromaticura Merr.
51. Parmelia ( Sange jaranath )
52. Crocus sativus Linn.
53. Cinnamomum camphora
Social Relevance: -
The maternal instinct is one of the strongest in the human female. Any woman, bom with a rudimentary uterus, given the choice, would accept the non-therapeutic administration in the hope of achieving womanhood and subsequently motherhood. The incidence of Mullerian Dysgenesis is just below 1 %. In a country like India, having half a billion women, the number of women having this defect is, to say the least, very large.
Clinical Identification :
■f
(a) Scanning (ultra-sonography) to spot the condition only.
(1) During neonatal period - neonatal scanning of the genitor-urinary system of all female babies, who do not have vaginal bleeding in the first week of life.
(2) Between 16 and 18 years - this would reveal the rudimentary uterus and has to be confirmed by a diagnostic laparoscopy. (by the presence of tubes)
(b) Astrology - An aphorism in astrology states " when the seventh house or
Navamsa. occupied by the seventh lord, be owned by the Sun, Mars or Saturn, without benefic aspects, her womb is likely to be defective ".In this case, Rasi chart shows Mars deposited in seventh house, which is its own house, (along with Venus) and Moon is posited in the Ascendent. Navamsa chart shows the seventh lord, Mars, as occupant of the house of Venus - (Rasi Ascendant).
(c) Palmar Dermatoglyphics - an avenue which needs to be explored.

In this invention, to overcome the stunted growth, the 11 Ayurvedic Compounds mentioned were given. They produced Differentiation, Growth (Hypertrophy) of uterus and Canalisation of both endometrial cavity and cervical canal. The Lining of the endometrial cavity became responsive to hormones and she has had two periods. It is evident that the totality of cumulative and combined effects (akin to synergism, which is usually manifested in short duration) of the different, distinct, known 11 Ayurvedic Compounds, given during the 8 phases (minimum duration - 32 months) has caused the growth of the rudimentary uterus and the uterus has become functional (patient has had two periods). Proof of growth has been confirmed by serial scans and the latest dimensions ofthe uterus are 5.8 cms. X 2cms. X 3 cms.

Brief Description - Drawings (No.l ), List Phases, Charts (No. 1 & 2).
Page 18 - drawing No. 1 - Figure on left
shows above frontal view and below side view and in each (1) tube, (2) rudimentary uterus - no cavity, no differentiation and (3) vaginal. Figure on right
shows the same features of the near normal sized uterus having cavity and differentiation into cervix and corpus.
Page 19 - List of Ayurvedic Compounds with text and dosage.
In Ayurveda, names of compounds depend upon the main ingredient. There are many compounds with the same name, depending upon text, from which the formulary has been taken.
Page 20 - Phases of Correction
Page 21 - Birth Defect - growth towards normalcy - ? Genetic Drive. - A comparative chart highlighting the changes from 1994 to 2006.
Page 22 - Serial USG Charts showing developmental changes - The chart shows ten USG scans of which two are follicular scans - 3/7/02 & 30/7/02 showing ovulation (1) from R. Ovary (2) from L. Ovary (proving that the HPOAxis is functional in both ovaries) and die remaining are pelvic scans. These scans show the developmental changes from scan 1 -rudimentary uterus to near normal uterus in scan 10. The scan on 3/7/02 showed a distinct cervix and the normal differentiation of uterus into corpus and cervix has taken place.
Page 23 Claims
Page 24 Abstract

I claim
1. An unique combination for correcting a natural defect of a rare form of Mullerian
Digenesis - rudimentary uterus - comprising l.Asoka Ghritham (AG), 2.Kalyanaka
Ghritham (KG), S.Aswagandhadi Lehyam (AGL), 4. Rajapravavarthana Vati (RPV)
, S.Kulatthadi Kashayam (KK), 6.Bala Thailam (BT), 7.Varanadi
Kashayam (VK), S.Chandraprabha Vati (CPV),9. Pushing Choomam Tablet
(PCT), 10. Asoka Arishtam (AA) and 1 l.Phalasarpis(PS).
2. An unique combination, as claimed in Claim 1 , wherein Asoka Ghritham(AG) is used
Individually in definite time interval.
3. An unique combination, as claimed in Claim 2, wherein the tune interval ranges from two months to nine months.
4. An unique combination, as in the preceding claim, wherein, during the definite time interval, the said ayurvedic ingredients is used daily.
5. An unique combination, as in the preceding claim, wherein, some of the ayurvedic ingredients are used in a combined manner.
6.An unique combination as claimed in clai m1 ,wherein, Kalyanaka Ghritham (KG) and Aswagandhadi Lehyam(AGL) are used for four months on a daily basis.
7. An unique combination as claimed in claim 1, wherein, Kalyanaka Ghritham (KG), Aswagandhadi Lehyam (AGL), Rajapravarthana Vati (RPV) and Kulatthadi Kashayam (KK) for three months on a daily basis.
8.An unique combination, as claimed in claim 1, wherein, Kalyanaka Ghritham (KG), Aswagandhadi Lehyam (AGL), Rajapravarthana Vati (RPV) ,Kulatthadi Kashayam(KK) with local application of Bala Thailam(BT), for five months, on a daily basis.
9. An unique combination, as claimed in Claim 1, wherein, Kalyanaka Ghritham (KG),
Aswagandhadi Lehyam (AGL) , Rajapravarthana Vati (RPV) ,Kulatthadi
Kashayam(KK), Bala Thailam(BT) and in addition Varanadi Kashayam(VK), for two months on a daily basis.
10. An unique combination, as claimed in claim 1 , wherein Kalyanaka Ghritham (KG),
Aswagandhadi Lehyam (AGL) , Rajapravarthana Vati (RPV) ,Kulatthadi
Kashayam(KK), Bala Thailam(BT), Varanadi Kashayam(VK), and Chandraprabha
Vati (CPV) for four months on a daily basis.
11 .An unique combination, as claimed in claim 1 , wherein Kalyanaka Ghritham (KG),
Aswagandhadi Lehyam (AGL), Rajapravarthana Vati (RPV) ,Kulatthadi
Kashayam(KK), Bala Thailam(BT), Varanadi Kashayam(VK), Chandraprabha Vati

(CPV) and at this step Pushing Choomam tablet (PCT) added, for nine months on a daily basis.
12.An unique combination, as claimed in claim 1 , wherein, Kalyanaka Ghritham (KG), Aswagandhadi Lehyam (AGL) , Rajapravarthana Vati (RPV) ,Kulatthadi Kashayam(KK), Bala Thailam(BT), Varanadi Kashayam(VK), Chandraprabha Vati (CPV) ,Pushing Choomam tablet (PCT) and Asoka Ghritham (AA) used thereafter , on a daily basis.
13.An unique combination, as claimed in the preceding claims, wherein , all the ayurvedic ingredients are used, as herein described, and shown in accompanying charts and drawing as evidence.

Documents:

0313-che-2005 abstract-duplicate.pdf

0313-che-2005 abstract.pdf

0313-che-2005 claims-duplicate.pdf

0313-che-2005 claims.pdf

0313-che-2005 correspondence-others.pdf

0313-che-2005 correspondence-po.pdf

0313-che-2005 description (complete)-duplicate.pdf

0313-che-2005 description (complete).pdf

0313-che-2005 form-1.pdf

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Patent Number

228654

Indian Patent Application Number

313/CHE/2005

PG Journal Number

12/2009

Publication Date

20-Mar-2009

Grant Date

05-Feb-2009

Date of Filing

28-Mar-2005

Name of Patentee

DR. E.C. SREEVALSAN

Applicant Address

PADMASREE, NO.10, V.G.P. SRINIVASA NAGAR, MADAMBAKKAM ROAD, CHENNAI 600 073,

Inventors:

#	Inventor's Name	Inventor's Address
1	DR. E.C. SREEVALSAN	PADMASREE, NO.10, V.G.P. SRINIVASA NAGAR, MADAMBAKKAM ROAD, CHENNAI 600 073,

PCT International Classification Number

A61

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA