JOURNAL TRANSCRIPT
International Journal of Ayurveda and Pharma Research
ISSN: 2322 - 0902 (P) ISSN: 2322 - 0910 (O)
Research Article CLINICAL STUDY OF CONTRACEPTIVE ACTIVITY OF TALISPATRA AND GAIRIKA Shete (Pimpale) Kapila
Reader, Shree Hingulambika Ayurvedic Medical College, Gulbarga, Karnataka, India. ABSTRACT The world population is increasing much faster. Many socio-economic conditions of people have also been adversely affected. Various side effects have been observed with modern contraceptive methods. In Ayurveda many contraceptive drugs are explained, According to Yoga-Ratnakar “Talispatra with Gairika” is considered as a potent contraceptive, hence to assess its clinical efficacy, Ovulatory effects, side effects of the formulation and to provide cost effective, safe and effective method of contraception and contribute to national health programme like family planning this study was under taken. Clinical study was conducted on 30 women, 15 in each group. In group I mixture of Talispatra (Taxus baccate) & Gairika (Red oxide) (10gm) a single dose was administered on 4 th day of menstrual cycle with cold water. In group II tab Mala –D daily one administered from 5th day of M. C for 21 days, follicular study was done on 11th day of M. C. in each patient observed for 3 cycles. In clinical study test drug in group I had shown In Ist, IInd, IIIrd month Dominant Follicle observed in one woman (6. 66%), eight women (53. 33%), twelve woman (80%) respectively and endometrial thickness observed less than 7mm in ten women (66. 6%), 4 women (26. 66%) 3 women (80%) respectively the study drug shown, significant contraceptive activity in I month than II, III month and group II. But side effects were noted only in group II. Mixture of Talispatra & Gairika had shown significant contraceptive activity. It is effective, safe, acceptable, less expensive enough to obviate frequent administration & without medical supervision. KEYWORDS: Talispatra, Gairika, Mala-D, Follicullar study, Contraceptive activity. INTRODUCTION Today there is pressing need for limiting the The clinical study was conducted to assess the family size at a personal level and for the control of contraceptive effects of mixture of Talispatra and Gairika population at a national level with the increase in and to provide a non-toxic, safe oral contraceptive to the population it is obvious that serious problems loom ahead main stream of national health programme like family unless the number of our progeny is controlled3. The planning. This clinical study was carried out to assess the world population is increasing at much faster rate. Fertility contraceptive effect of mixture of Talispatra and Gairika control is very essential for maintaining satisfactory and to provide non toxic, safe oral contraceptive to the standards of living and for raising the existing standards in main stream of national health programme like family developing countries. A method or a system which allows planning. intercourse and yet prevents conception is called a MATERIALS AND METHODS contraceptive method. Contraceptive measures may be Thirty Women from both O. P. D. and I. P. D. of used to avoid pregnancy entirely, to space pregnancies or Banale nursing home, Gulbarga were included for the to temporarily postpone pregnancy. 4Presently available study. Mixture of Shodhita (Purified) Gairika & Talispatra Oral contraceptives like Mala-D, Mala-N, Ovral-L, Novelan churna, Mala-D, cold water and women (having child and may induce weight gain, nausea, headache, CA of Cx, CA of regular menstrual cycle) formed the materials for clinical breast, certain neurologic and neuro-opthalmologic study. Shodhan (Purification) of Gairika & Talispatra syndrome, candida vaginitis, trichomans vaginitis. 5 churna were prepared in the practical pharmacy and used Because of all these above side effects the basic for this study. expectations of woman are with contraception which is Sample Size: 30 Women were selected considering the safe, effective, acceptable, less expensive, simple to inclusive and exclusive criteria& distributed 15 in each administer, independent of coitus, long lasting enough to group. obviate frequent administration and requiring little or no Inclusive Criteria medical supervision. Ayurvedic scholars have used safe, 1. Healthy women having the age between 22 years to reliable contraceptives since many centuries. As a witness 40 years were selected. to this Yoga-Ratnakar (17th A. D) has mentioned the 2. Women of child bearing age and possessing at least combination of Talispatra (Taxus Baccata) and Gairika two children and 1-11/2 years after second child. (Red Oxide) taken in equal quantity and administered in a th dose of 1 Karsha (10 grams) on 4 day of Rajakala 3. The women those who were having regular (Menustrual cycle) with cold water as Anupan (Vehicle). 6 menstrual cycle. IJAPR | September 2016 | Vol 4 | Issue 9
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Shete Kapila. Clinical Study of Contraceptive Activity of Talispatra and Gairika
4. Women not desirous of having further child. 5. Women having a child & voluntarily willing to take the drug, after taking proper consent. Exclusive Criteria 1. Unhealthy women and age below 22 years & above 40 years. 2. Women suffering from anaemia, T. B., diabetes mellitus, ovarian cyst, fibroid etc. 3. Unmarried, newly married women. 4. Women having secondary amenorrhoea and other gynaecological disorders. 5. Women those having irregular menstrual cycle. Methods: Clinical study was conducted in 2 groups, each containing 15 Women.
1]. Group I (study group) Administration of mixture of S. Gairika (5 grams) + Talispatra churna (5 grams) with cold water on the 4th day of menstrual cycle, single dose, for only one cycle. (as per text Ref. ) 2]. Group II (standard group) Administration of Mala-D 1 tablet daily from 5th day of menstrual cycle for a period of 3 cycle. (as per drug schedule). Both groups were observed for 3 consecutive menstrual cycles. A detailed history was noted. Women were asked to come in between 11 th to 13th day of menstrual cycle for follicular study for 4 consecutive cycles. Follicular study by Transvaginal Scan was done for 4 consecutive cycles. Parameters Follicular study Before T/T After T/T - 11th to 13th day of menstrual cycle for 3 cycles.
OBSERVATION AND RESULT Table no. 1 Following table shows change in appearance of the Dominant Follicle after treatment in group I (n=15) Sl. No.
Month
No. of women in which Dominant Follicle appeared after T/T (%)
No. of women in which Dominant Follicle did not appear after T/T (%)
Statistical test
χ2= 16. 607
1
First
1 (6. 66%)
14 (93. 32%)
2
Second
8 (53. 33%)
7 (46. 66%)
3
Third
12 (80%)
3 (20%)
P value
applied HS P=0. 000
Table no. 2 shows change in the Endometrial thickness after treatment in group I (n=15) Sl. No.
Month
No. of women in which endometrium is less than 7 mm (%)
No. of women in which endometrium is more than 7 mm (%)
Statistical test
χ2= 8. 130
1
First
10 (66. 66%)
5 (33. 33%)
2
Second
4 (26. 66%)
11 (73. 33%)
3
Third
3 (20. 00%)
12 (80. 00%)
P value
applied HS P=0. 017
Table no. 3 shows change in the appearance of Dominant Follicle before and after treatment in group II. Sl. No.
Appearance of dominant follicle
Before treatment
After treatment 1st month
2nd month
3rd month
1
No. of women in which Dominant Follicle appeared
15 (100%)
0 (0%)
0 (0%)
0 (0%)
2
No. of women in which Dominant Follicle not appeared
0 (0%)
15 (100%)
15 (100%)
15 (100%)
Table no. 4 shows change in the Endometrial thickness before and after treatment in group II. (n=15) Sl. No.
Endometrial thickness
Before treatment
After treatment 1st month
2nd month
3rd month
1
No. of women in which endometrial thickness is less than 7mm
0 (0%)
15 (100%)
15 (100%)
15 (100%)
2
No. of women in which endometrial thickness is more than 7mm
15 (100%)
0 (0%)
0 (0%)
0 (0%)
Available online at: http://ijapr.in
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Int. J. Ayur. Pharma Research, 2016;4(9):39-43 Graph-change in the appearance Graph-Change in the Endometrical of Dominant Follicle before and after thickness before and after treatment (Rx) in group I. (n=15) treatment (Rx) in group I (n=15) % of women according to Endometrial thickness
% of women according to D.F appearance 120% 100% 100%
120% 100%
93.33%
80%
% of women in which D.F appeared
53.33% 46.66%
60% 40% 20%
100%
80%
20% 0%
80%
73.33%
66.66%
80%
60%
% of women in which D.F not appeared
33.33%
40%
6.66%
20%
0%
26.66%
20%
% of women in which endometral thichness 7mm
0%
0%
Before Rx After Rx 1 After Rx 2 After Rx st month nd month 3rd month
Before Rx After Rx 1 After Rx 2 After Rx st month nd month 3rd month
Graph -Change in the appearance of Graph - Change in the Endometrial Dominant Follicle before and after thickness before and after treatment (Rx) treatment (Rx) in group I (n=15) in group II. (n=15) % of women according to D.F. appearance 120% 100% 100% 80% 60% 40% 20% 0%
0%
100%
0%
100%
0%
100%
0%
% of women in which D.F. appeared % of women in which D.F. not appeared
Before After Rx After Rx After Rx Rx 1st month 2nd 3rd month month
DISCUSSION The combination of Shodhita Gairika and Talispatra churna was administered with cold water on the 4th day of menstrual cycle acts as a contraceptive, has been explained in Yoga-Ratnakar. Hence an attempt was made in this clinical study to assess the contraceptive effect of the formulation. 30 women were selected considering inclusive and exclusive criteria during the period from June 2007 to August 2008. Detail history, clinical examination of the women was conducted. All the women were asked to come on 11th-13th day of menstrual cycle before the administration of drug for follicular study by Transvaginal Scan (TVS) for confirmation of Ovulatory cycles & to rule out pathological disorders in group I, mixture of Talispatra and Gairika (10 gm) administered on 4th day of menstrual cycle with cold water single dose in one cycle only. In group II, 15 women were selected and Mala-D one tablet daily administered from 5th day of menstrual cycle 21 days for 3 cycles and asked them to come on 11th -13th day of menstrual cycle for follicular study by Transvaginal scan for 3 cycles. In Group I: Before the drug administration it was noted by transvaginal scan that 15 women had dominant follicle and endometrium thickness was more than 7mm. Then mixture of Talispatra and Gairika (10gm) was administered on 4th day of menstrual cycle, single dose and observed for 3 consecutive menstrual cycles without
% of women according to Endometrial thickness 120% 100% 80% 60% 40% 20% 0%
100% 100%
0%
0%
100%
0%
100%
0%
% of women in which endometrial thickness < 7mm % of women in which endometrial thickness >7mm
Before After Rx After Rx After Rx Rx 1st 2nd 3rd month month month
administration of this test drug or any other contraceptive drug. After the drug administration on 4th day of menstrual cycle, 11th day the reports of tranvaginal scan in 1st month it was noted that 14 women had no Dominant Follicle but in only one woman Dominant Follicle was observed. In 10 women endometrial hypoplasia was noted. No any other problems with their menses and other complications were noted. Then again all the women were asked to come on 11th – 13th day of menstrual cycle in second month without taking any contraceptive medicine and Follicular study was done by Transvaginal scan. In second month out of 15 women Dominant Follicle appeared in 8 women and DF not appeared in 7 women and endometrial hypoplasia was noted in 4 women. None of the women had menstrual problem or any other complication. Then again all the women were asked to come on 11th-13th day of menstrual cycle in third month without taking any contraceptive medicine. Follicular study was done by TVS. In 3 women no Dominant Follicle but 12 women had Dominant Follicle. In 12 women endometrial thickness was increased but in 3 women endometrial thickness was