~~YDYSMENORRHOEA}ACLINICALSTUDY

J.R.A.S. Vol. XXXI, No.3, July -Sept. 10 pp. 15-28 A COMPARATIVE STUDY ON THE EFFECT OF DASHAMOOL TAILA UTTARBASTI AND VIJAYADI VATI IN THE MANAGEMENT OF KASHTARTAVA ~~YDYSMENORRHOEA}ACLINICALSTUDY Anuradha Royl, A. Pandya and B. Ravishankar' Abstract With the advent of new millennium and the herald of high-tech era, women 's status was expected to reach new horizons both socially and physically. But some of the physiological things trouble the lady to make her slow down the race. Such aproblem is Kashtartava (menstrual pain/dysmenorrhoea). Kashtartava is referred as symptom of various Yonivyapadas (gynaecological complaints) in Ayurveda. In this present study, primary dysmenorrhoea is considered as a classicalfeature and apart of disease Kashtartava. The drugs Dashamoola Taila and Vijayadi Vati have been taken for the clinical trial. Because of the side effects due to longstanding administration of antispasmodic, analgesics, PG synthesis inhibitor etc. used in modern medicine and even they do not exert permanent solution, hence we are searchingfor an alternative cure from our ancient heritage which will be cost effective, easily available and better solution to the ailment. I. M.S. (Ayu.), Striroga & Prasuti Tantra, Lecturer & R.M.O., SSMD. Ayurvedic College & Hospital, Moga, Punjab 2. Head, Deptt. of Kaumarbhritya; I.P.G.T. & R.A. Gujarat Ayurved University 3. Head, Deptt. of Pharmacology; I.P.G.T. & R.A.; GujaratAyurved University. 15

Anuradha Roy et al. Introduction Most women experience minor psychological and somatic changes for a few days preceding menstruation and during the days. Once the menstruation is over, these menstrual molimina will disappear leaving behind an anxiety free well beingness in the lady. When she has painful menstruatio in fully blown up and exaggerated manner then it becomes dificult for her. In Today's era 50% women suffer from primary dysmenorrhoea out of which 10% become bed ridden during the periods. The disease 'Kashtartava' is not described in classics as an individual disease entity. It is described as a symptom of various Yonivyapadas specially Udavarta, Vatala, Sannipatika etc. But in present scenario, looking at its high prevalence rate, it is considered as separate disease primarily due to vitiation of Vat a dosha (Apana and Vyana Vayu) which simulates the clinical features of primary dysmenorrhoea. From the treatment peint of view, Dashamool Taila Uttarbasti is selected in one group. It helps to revitalize the hormonal system, giving youthfulness and stamina to the body. Uttarbasti has the added benefit of increasing Ojas, replenishing the hormonal system and promoting fertility. This treatment also gives vibrant energy to the female organs and excellent in Vatashamaka. In another group Vijayadi Vati is selected, which has a direct reference in Bhaishajya Ratnavali as an oral drug. Both these groups have been compared with Placebo group, as the disease 'Kashtartava' has psychosomatic influence. Total 55 patients were registered, out of which 48 patients had completed their treatment along with the follow up study. All the data evolved are helpful in lying down a probable conclusion that intrauterine Uttarbasti is giving better effect than Vijayadi Vati oral group. Materials and Methods Selection of Drugs Dashamoola Taila is one of the best Vatashamaka drugs and Bastikarma is the principal treatment for Vat a as well as for Yoniroga. Vijayadi Vati is indicated in Kashtarvata. Thus these two drugs are selected for the present clinical trial as Uttarabasti & oral therapy respectively. Preparation of Drugs Dashamoola Taila - First the Dashamuola is dipped in water for over night and next day Kwatha is prepared. This Kwatha along with Kalka Dravya is added in Tila Taila and Sneha is prepared as per standard protocol. 16

A COMPARATIVE STUDy. Vijayadi Sattwa is purified Vati - First of all, Bhanga in milk, dried and powdered. Equal parts of all the other three ingredients i.e. Rakta Kamala Moola, Apamarga Moola and Kumari Sara are mixed well and given Bhavana ofdistilledwater.then Vatiwere prepared of 1 Ratti () 25 mg) each (Bhaishajya Ratnavali/ Yonivyapada/65-6 7). All these procedures were carried out in the pharmacy oft.p.g.t. & R.A., Jamnagar. Selection of Cases A total of 55 patients of Kashtartava were selected from O.P.D. of T.P.G.T. &R.A., Hospital, G.A.U., Jar-magar, For Uttarbasti group: Married women were selected. For oral groups: Both married and unmarried were selected. Criteria ofinclusion Patients coming with chief complaint of Kashtartava (primary dysmenorrhoea) with scanty or average amount of menses along with associated symptoms. Age group between 12-40 years. Dose, Time and Duration the Patients of drugs in Dashamoola Taila - Uttarbasti (Test), 5 mllday for 3 consecutive days after cessation of menses, 2 cycles. Vijayadi Vati- Oral group (Test), 2 Rati twice daily (500 rng/day), for 2 months. Roasted wheat powder - Oral group (Placebo), 250 mg twice daily (500 mg/day), for 2 months. Patients suffering for more than 2 cycles. Criteria of Exclusion Patients below 12 years and above 40 years. Patients with chronic general illness. Patients with intrauterine contraceptive devices. Menorrhagia Any uterine pathology - fibroid, adenomyosis, endometriosis. Grouping of Patients In the present study all the patients were divided into three groups- 17

Anuradha Roy et al. Group-A : Dashamoola Taila - Uttarbasti (Test)- only married women (15 completed cases). Group-B : Vijayadi Vati - Oral group (Test)- both married & unmarried women (18 completed cases). Group-C : Roasted wheat powder - Oral group (Placebo)- both married & unmarried women ( 15 completed cases ). Parameters for assessment of the drug response It has been assessed on the basis of subjective and objective improvement in each follow up (after menses) for main symptoms like pain in hypogastrium, low back pain and pain in legs, associated symptoms like Yonikandu, Malasanga, Daurbalya, Angamarda, Shirahshula and Pindikodwestana as well as signs and symptoms related with Artavavaha srotas. Table-I Effect of therapy on Artavavaha Srotasa (Group-A) Particular No. of Mean % pts. B.T. I A.T. imp. S.D. S.E. 't' P Artavakshaya 01 03 01 66.66 0.00 (Pramana) Artavakshaya 03 2.67 01 62.551-0.57 0.33 5.00 <0.05* (Avadhi) Vandhyatva 05 03 1.8 40.00 1.64 0.73 1.63 >0.10 Kashtartava 15 03 0.77 75.671-0.79 0.20 10.02 <0.001 ** Maithuna 01 03 01 66.66 0.00 Asahishnuta Observations and Results Effect of therapy in Artavavaha Srotasa Group A showed statistically significant (t=05.00, P<0.05) in Artavakshaya Avadhi, while highly significant (t=10.02, P<O.OOI) result in Kashtartava (Table- J). 18

A COMPARATIVE STUDy. Particular Artavakshaya (Pramana) Artavakshaya (Avadhi) Vandhyatva Kashtartava Maithuna Asahishnuta Table-II Effect of therapy on Artavavaha Srotasa (Group-B) Mean No. of % S.D. S.E. 't' pts. B.T. I A.T. imp. P 03 3.0 0.66 77.661' 0.57 0.33 7.00 <0.05* 03 2.8 0.60 78.571' 0.83 0.37 5.87 <0.05* 02 18 3.0 3.0 3.00 0.00 0.66 68.671' 0.66 0.15 14.44 <0.001** Group-B showed statistically significant in Artavakshaya Pramana (t=07.00, P<0.05) and Artavakshaya Avadhi (t=05.87, P<0.05) while, statistically highly significant (t=14.44, P<0.001) result In Kashtartava (Table -II). Particular Table-III Effect of therapy on Artavavaha Srotasa (Group-C) Mean No. of % S.D. S.E. 't' pts. B.T. I A.T. imp. P Artavakshaya 05 2.60 2.40 7.69 0.44 0.20 1.00 >0.10 (Pramana) Artavakshaya 04 2.50 2.25 10.00 0.50 0.25 1.00 >0.10 (Avadhi) Vandhyatva 01 3.00 3.00 Kashtartava 15 3.00 2.80 6.66 0.41 0.10 1.87 >0.10 Maithuna Asahishnuta In group C, statistically non in all the particulars (Table-Ill). significant (P>O.lO) result was observed 19

Anuradha Roy et al. Comparative Effect of Therapy on Kashtartava Table-I V-A Between Group A and Group C (vide Artavavaha Srotasa) Groups No. of Mean 0/0 pts. B.T. S.D. S.E. I A.T. imp. 't' p Group C 15 3.00 2.80 6.66 0.41 0.10 1.87 >0.10 Group A 15 3.00 0.77 75.671' 0.79 0.20 10.02 <0.001 ** Table-IV-B Between Group B and Group C (vide Artavavaha Srotasa) Groups No. of Mean % S.D. S.. pts. B.T. I A.T. imp. 't' P Group C 15 3.00 2.80 6.66 0.41 0.10 1.87 >0.10 Group B 18 3.00 0.66 68.671' 0.66 0.15 14.44 <0.001** Table-IV-C Between Group A and Group B (vide Artavavaha Srotasa) Groups No. of Mean 0/0 S.E I 1 pts. B.T. S.D. 't' I A.T. I imp. P 1 Group A 15 3.00 0.77 75.671' 0.79 0.20 10.02 <0.001 ** Group B 18 3.00 0.66 68.671' 0.66 0.15 14.44 <0.001 ** In comparative study of the disease Kashtartava (vide Artavavaha Srotasa), group A showed statistically highly significant(t=10.02, P<O.OO1)in comparison to group C (t=01.87, P>O.lO). Similarly group B showed statistically highly significant (t=14.44, P<O.OOl) in comparison to group C (t=01.87, P>0.10). Whereas both the group A (t=10.02, P<O.OOI) and group B (t=14.44, P<O.OOl) were found statistically highly significant but in comparison group-a provided 75.67% and group B 68.67% relief (Table IV-A, IV-B & IV-C). Symptoms p Pain in hypogastrium Low back pain Pain in legs 92.661' 93.331' 74.801' 0.42 0.11 24.47 <0.001** 0.4] 0.10 26.19 <0.001** 1.04 0.31 06.06 <0.001 ** 20

A COMPARATIVE STUDy. Effectoftherapyonmainsymptoms significant in reducing pain In The effect of therapy in Group A was observed statistically highly hypogastrium (t=24.47, P<O.OOI), low back pain (t=26.19. P<O.OOJ) and pain in legs (t=06.06, P<O.OOI)(Table-V). Table-VI Effect of therapy on main symptoms (Group-B) Symptoms Pain in hypogastrium 17 78.331' 0.49 0.11 19.69 <0.001** P Low back pain 14 2.21 0.71 64.251' 0.64 0.17 8.27 <0.001** Pain in legs 08 2.12 0.75 64.621-0.51 0.18 7.51 <0.001 ** Group-B also showed statistically highly significant result in reducing pain in hypogastrium (t=19.69, P<O.OOI), low back pain (t=8.27, P<O.OOI) and pain in legs (t=07.51, P<O.OOI) (Table-VI) Table-VII Effect of therapy on main symptoms (Group-C) Symptoms Pain in hypogastrium 15 16.081' 0.83 0.21 2.16 >0.05* P Low back pain 12 2.83 2.33 17.66 0.90 0.26 1.91 <0.05 Pain in legs 06 2.33 1.83 21.46 0.83 0.34 1.46 <0.10 In Group-C, only statistically significant (t=02.16, P<0.05) result was obtained III reducing pain m hypogastrium only (Table- VII). Symptoms A.T. P Yonikandu 06 0.00 1001-0.98 0.40 4.56 <0.01** Malasanga 06 0.16 87.201-0.40 0.16 7.00 <0.01** Oaurbalya 12 01.00 42.851' 0.45 0.12 5.74 <0.01 ** Aruchi 12 0.50 56.391-0.45 0.13 5.74 <0.01 ** Angamarda 09 0.22 79.201-0.33 0.11 8.00 <0.01 ** Shirahshula 09 0.66 56.741-0.33 0.11 8.00 <0.01 ** Pindikodwestana 10 0.30 80.001-0.78 0.24 4.81 <0.01 ** 21

Anuradha Roy et al. Effect of therapy on associated symptoms In group-a, Yonikandu (t=04.56, P<O.O 1), Malasanga (t=07.00, P<O.OO 1), Daurbalya (t=05.74, P<O.OO 1), Angamarda (t=08.00, P<O.OOl), Shirahshula (t=08.00, P<O.OO I) and Pindikodwestana (t=04.81, P<O.OO1) were found statistically highly significant result (Table- VIU). Table-IX Effect of therapy on main symptoms (Group-B) Symptoms No. of Mean % pts. B.T. I A.T. imp. S.D. S.E. 't' P Yonikandu 04 1.25 0.50 60.00 0.50 0.25 3.00 >0.05 Malasanga 09 1.77 0.66 62.711' 0.60 0.20 5.54 <0.01 ** Daurbalya 15 1.93 0.93 51.821' 0.53 0.13 7.24 <0.01 ** Aruchi 10 1.20 0.10 91.661' 0.31 0.10 11.00 <0.01 ** Angamarda 08 1.62 0.37 77.161' 0.70 0.25 5.00 <0.01 ** Shirahshula 07 1.85 0.71 61.621' 0.37 0.14 8.00 <0.01** Pindikodwestana II 2.09 0.45 77.991' 0.67 0.20 8.04 <0.01 ** In group B, symptoms like Pindikodwestana (t=08.04, P<O.OOI) Malasanga (t=05.54, P<O.OOl), and Aruchi (t=-11.00, P<O.OOI) were Daurbalya (t=07.24, P<O.OOl), found statistically highly significant Angamarda (t=05.00, P<O.OO1), result (Table-IX). Shirahshula (t=08.00, P<O.OOl) and Effect of therapy Table-X on main symptoms (Group-C) Symptoms P Yonikandu 0.00 Malasanga 0.00 Daurbalya 15.38 0.42 0.13 1.50 >0.10 Aruchi 10.93 0.37 0.14 1.00 >0.10 Angamarda 25.00 0.46 0.16 1.52 >0.10 Shirahshula 23.14 0.54 0.22 2.23 >0.05 Pindikodwestana 8.91 0.37 0.14 1.00 >0.10 In group -C, the effect of therapy was found statistically non-significant 22 (p>o.1 0) (Table-X).

A COMPARATIVE STUDy. Table-XI Percentage Relief of the patients in all the three groups % relief Effect Group -A Group-A Group-A No. of I No. of I No. of I 0/0 0/0 pts. >75 Cured 08 53.33 08 44.44 00 00.00 51-75 Markedly 05 33.33 04 22.22 00 00.00 improved 25-50 Improved 02 13.33 04 22.22 04 26.66 <25 No improvement 00 00.00 02 11.11 11 73.33 pts. pts. 0/0 Percentage Relief of the patients in all the three groups Overall effect of therapy revealed that in group A, 8 patients (53.33%) had >75% relief, 5 patients (33.33%) were markedly improved and 2 patients (13.33%) were improved. In group-b, 8 patients (44.44%) had >75% relief, 4 patients (22.22%) had marked improvement, same number of patients (22.22%) had improvement and only 2 patients (11.11%) were having no improvement. In group-c, only 4 patients (26.66%) were improved and 11 patients (73.33%) were having no improvement (Table -XI). Discussion In Ayurvedic classic Kashtartava is not considered as a separate disease entity but described as a symptom of many gynaecological disorders. In the present study we considered it as an independent disease, is mainly due to derangement of Vata Dosha, caused by Margavarodha, Dhatukshaya and Swanidana Prakopa. In this present study, total 48 patients were given treatment along with follow up study. Maximum numbers of patients were of the age group between 12-20 years, from nuclear families, duration of chief complaints more than 6 years, 40.00% of patients had positive family history with 27.27% of mother positive. 70.91 % had pain only during 1St day of menses with 96.36% had pain in hypogastrium and 85.45% in low back, 83.64% had cramp type of pain and 14.55 % had infertility. 23

Anuradha Roy et al. It is well established that Til Taila is polyunsaturated fatty acid, which ultimately intensifies the penetration of oil based substances through the cell membrane. The cell membrane is composed of lipid bilayer, which has an inherent capability of movement, and this movement is directly proportional to the temperature. This may be the reason to heat the oil in mild temperature before administration of Uttarbasti. Dashamoola having Shothahara effect, as one patient with cervical erosion and oedematous cervix when given Uttarbasti of it showed rapid decrease in the symptom. The oedematous cervix became quite normal after three days of Uttarbasti which can be further studied for. Significant result was found in Pramana of Artavakshaya in group-b, also in group-a. It shows that due to Margavarodha by Vata there was Artavakshaya. Probably both the test drugs pacify the vitiated Vata especially Apana Vayu, the symptoms subsides. In group-a, 5 patients were having infertility and may be due to the action of'dashamoola Taila Uttarbasti we got 40% results and patients become pregnant, which is a significant achievement. Out of them, I patient was of 6 years of infertility and I having recurrent abortion. Again in group-a, 1 patient was having MaithunaAsahishnutva and we got 66.66% improvement in her. On main symptoms, highly significant results were obtained in both group -A and B in all the symptoms and in group-c significant result was found only in reducing pain in hypogastrium. This shows the effect of patient's psychology upon the disease. Hence it proves the disease to be psychosomatic and the drugs to have properties of Vatanulomana and Vedanasthapana. On associated symptoms, both group A and group B had shown statistically highly significant result in reducing most of the symptoms but group A showed better improvement along with reducing the symptoms like Asthisandhi Shoo la, Anidra and Guruta of the body. Conclusion Very encouraging result (75.67%) was found in group A (Uttarbasti) in the main cardinal features than group B. In group B (Vijayadi Vati) also quite encouraging result (68.67%) was found but there was less effect In associated symptoms than group A. 24

A COMPARATIVE STUDy. We got quite good result in the patients of infertility after the two courses of Uttarbasti of Dashamoola Taila. The oedematous cervix became quite normal after three days of Uttarbasti suggesting its Shothahara effect. In group-c (Placebo) a very small fraction of patients were having slight improvement in symptoms which suggests the disease to be psychosomatic in nature. It is just the psychology of the patient, which has given slight relief in pain due to Kashtartava. Journals I) The Journal of Pharmacology and experimental therapeutics. Vol. 306, Number 2, August 2003, American Society for Pharmacology and Experimental Therapeutics. 2) Gynaecology and Obstetrics updates, Vol. 2, No.2. 3) Muse (1990) Cyclic Pelvic Pain, Obstetric and Gynaecology Clinics of North America, 17(2), 427-440. 4) Clinical Evidence, 10 (Dee), 2058-2078,2003. 5) Current Medical Literature Gynaecology and Obstetrics, Dabur Pharma Ltd. 6) British Journal of Obstetrics and Gynaecology (SJOG), 2005, August. 112(8); 1164. Scoring Pattern of Symptoms (Multidimensional Scoring Pattern) o Menstruation is not painful and daily activity unaffected. 1 Menstruation is painful and daily activity not affected. No analgesics required. 2 Menstruation is painful and daily activity affected, analgesics were needed. 3 Menstruation is painful, she cannot do even her normal routine work and has to be absent from class or office during menses. She has to take analgesics but have poor effect. o No Kandu 1 Occasionally Gradation of Associated Symptoms 1. Yonikandu 2 Kandu only 2-3 days (mild to moderate) 3 Kandu more than 3 days (severe) 25

Anuradha Roy et al. o 2. Artava Pramana (Assessment by Pad) 6-7 pads/cycle 1 4-5 pads/cycle 2 2-3 pads/cycle 3 Spotting or 1pad/cycle o 3. Artavakshaya Avadhi Duration of menses 4-7 days. 1 Duration of menses 3 days. 2 Duration of menses 2 days. 3 Duration of menses 1 days. o No Malasanga. 4. Malasanga 1 Frequency once in a day, but hard stool pass. 2 Frequency of stool alternative day and patient fills difficulty in defecation. 3 Patient can not pass stool without any purgative agent even after 3-4 days. o Absence pf symptoms 1 Mild 2 Moderate 3 Severe 5. General Evaluating Scale 6. Overall Assessment of Therapy It is assessed on the basis of percentage of relief obtained % of relief >75 51-75 25-50 <25 Effect : Cured : Markedly improved :Improved : No improved 26

A COMPARATIVE STUDy. Prof. Sharma P.V. Vd. Acharya 1.T. Prof. Sharma P.V. Prof. Murthy K. R. S. Prof Murthy K.R.S. ShuklaG.D. SatyapaJ Prof. Sharma P. V. Shastri A.D. Prof. Tiwari P.V. Prof. Singh R. H. References 2003 Charaka Samhita (English translation and critical notes), Vol. I-IV, x" edition, Chaukhambha Orientalia, Varanasi. 2000 Charaka Samhita with Ayurveda Deepika commentary, Reprint edition, Chaukhambha Surabharati Prakashan, Varanasi. 1999 Sushruta Samhia (English translation and Dalhans's commentary along with critical notes), Vol. I-III, r edition, Chaukhambha Visvabharati, Varanasi. 2003 Ashtanga Samgraha of Vagbhata (Text, English translation, Notes, Indeces etc.), Vol. I-Ul, 4th edition, Chaukhambha Orientalia, Varanasi. 1991 Ashtanga Hridaya of Vagbhata with English translation, Vol. I-II, Krishnadas Academy, Varanasi. 1959 Bhela Samhita of Acharya Bhela with Hindi translation, I st edition, Chaukhambha Vidhya Bhavan, Varanasi. 1953 Kashyapa Samhita with Hindi commentary, Chaukhambha Sanskrit Series, Varanasi. 1993 Chakradatta with Ratnaprabha commentary, I" Swami Ramprakash Trust, Jaipur 1969 Bhaishajya Ratnavali by Govinddas with Vidyotini Hindi commentary, Chaukhambha Sanskrit Series, Varanasi. 2000 Ayurvediya Prasutitantra Evam Stree Roga, Istand 2 nd part, 2 nd edition, Chaukhambha Orientalia, Varanasi. 1998 The Holistic Principles of Ayurvedic Medicine, 1stedition. 27

Anuradha Roy et at. Jonathom S. Berek DawnC.S. Dutta D.C. Dawn C. S. & Dawn S Novak's Gynaecology, Hillard. Edi. 4 Adashi Paula A 1997 Text Book of Gynaecology including Contraception, 12'hedition. 2000 Text Book of Gynaecology including Contraception, 2nd edition, New Central Book Agency (P) Ltd., Calcutta 2003 Text Book of Gynaecology, Contraception & Demography, 14th edition, Dwan Books, Kolkata. Bennett P.N. & Brown M. 1. 2005 Clinical Pharmacology, 9 th edition, Elsevier, New Delhi. Guyton & Hall Prof. Singh R. H. Medicine, 2000 Text Book of Medical Physiology, 10 th Edition, Elseveir, New Delhi. 1998 The Holistic Principles of Ayurvedic 1stedition. ~il'(l~ q;~ijq qft ~ 1l G~I~(i1~ qft \3t1~qR-a ~ fch11~i~ ~ ~ ~1{fq cnt~<.'1~lfflq; 3lUflFf (~TtlT ~, ~. qlo~lll ~ 6lI. xfcl~icf)x) Cf)~ Ictq ~31T -it LfPlT \i'i"r crrc;rr ~ xi IiOj I<x:/ -FctCB-R~ I ~ -it ~ ~ ~ cfi ""'I~ &:IIq ~'j cfi CfalUT cfi ~ -it 11RT 1l<lT ~ I ~ ~ -it m~ Cf)~lctq em ~ ~ cfi ~ cfi ~ -it N~Cf)lx ~ rrzn ~ I ~ 31~ %g ~~I~C1 "ffi1 ctt \3f1 x q f«1 ~ Fcl\Ji1l1R cri em ~ 31~ cfi ~ 'TIT ltm I ~ "x1ftr:d em ~~-it q/ihfd ~1l<lT I ~-1 -it 15 ~ em ~~I~C1"ffi1 ctt \3f1XC1f«1 eft ~ I ~-2 -it 18 ~ em Fcl\JillIR cret Cf)[ ~ ~ 1l<lT (f~ ~-3 -it 15 ~ em <Tt ~ ~ cfi ~ -it ~ 1l<lT I 31Ulll"l qx 1"i1 ~~ ~ ~ -it 3ITffi ~ CfP1 LfPlT 1l<lT I (Approved on 10-11-2008) 28