|Year : 2022 | Volume
| Issue : 1 | Page : 11-16
An open-label randomized comparative clinical study of different Panchakarma therapies in female infertility
Sarvesh Kumar Singh1, Archana Kushawaha2, Kshipra Rajoria1, Hetal Harishbhai Dave3
1 Department of Panchakarma, National Institute of Ayurveda, Jaipur, Rajasthan, India
2 Department of Ayurveda, Rajkiya Ayurvedic Chikitsalaya, Bawli, Jalaun, Uttar Pradesh, India
3 Department of Stri and Prasuti Tantra, National Institute of Ayurveda, Jaipur, Rajasthan, India
|Date of Submission||16-Jun-2021|
|Date of Decision||12-Aug-2021|
|Date of Acceptance||14-Aug-2021|
|Date of Web Publication||19-Mar-2022|
Sarvesh Kumar Singh
Department of Panchakarma, National Institute of Ayurveda, Jaipur, Rajasthan
Source of Support: None, Conflict of Interest: None
Introduction: Comparative role of different Ayurveda therapies in the treatment of female infertility. Methods: It was an open-label, comparative, randomized trial. Thirty female patients were equally divided into two groups as Group A, treated with Virechana karma (Purgation therapy) followed by yoga basti (Ayurveda enema therapy) regimen and Group B treated with Yoga basti followed by Uttarabasti (Ayurveda intrauterine therapy) regimen. In Group A, Virechana was done with Tilvakaghrita followed by Erandmooladi yoga basti and in Group B Erandmooladi yoga basti was administered followed by Uttarabasti with Bala taila. The variables used for assessments were conception, grading in menstruation parameters, spinnbarkeit (SB) test, fern test, follicular study, and endometrial thickness. For intragroup comparison, “Wilcoxon matched-paird signed-ranks test” and “paired t-test” were used. For intergroup comparison, “Mann–Whitney test” and “unpaired-t-test” were used. All the statistical tests were interpreted as significant at 5% level (P < 0.05). Results: The median age of these participants was 28 years (range, 20–36). In Group A, there were statistically significant improvements in the follicular study, SB test, menstrual parameters, and dyspareunia after the trial. In Group B, there were statistically significant improvements in endometrial thickness, Fern test, SB test, amount of menstruation, duration of menstruation, and dysmenorrhea. On comparison, there was a statistically insignificant difference between these two groups in the outcome. Conclusion: Ayurveda purgation-enema therapies and Ayurveda enema-intrauterine therapies are equally effective in the management of female infertility.
Keywords: Erandmooladi yoga basti, female infertility, uttarabasti, vandhyatva, virechana karma
|How to cite this article:|
Singh SK, Kushawaha A, Rajoria K, Dave HH. An open-label randomized comparative clinical study of different Panchakarma therapies in female infertility. J Ayurveda 2022;16:11-6
|How to cite this URL:|
Singh SK, Kushawaha A, Rajoria K, Dave HH. An open-label randomized comparative clinical study of different Panchakarma therapies in female infertility. J Ayurveda [serial online] 2022 [cited 2022 May 16];16:11-6. Available from: http://www.journayu.in/text.asp?2022/16/1/11/339980
| Introduction|| |
At present time, female infertility is a major issue in developed or developing countries. In the Demographic Health Survey of developing countries (1994–2000) of WHO there was an estimate that 186 million women suffer from infertility despite repeated failed attempts for at least 5 years. There are various options available to manage female infertility such as clomiphene citrate (CC) therapy, hormonal therapy, surgical therapy for adhesion, artificial insemination, in vitro fertilization, and embryo transfer. However, these are associated with drawbacks such as extreme expensiveness, ovarian hyperstimulation, frequent abortion, multiple gestation, major long-term possibility of ovarian cancer, and most importantly not successful every time in every patient. There is a need of an alternative management that is cost-effective, free from complications, and beneficial in the larger population. There are evidence of success in the management of female infertility through Virechana karma, Bala taila uttara basti, and Basti. Thus, the present clinical study was planned to assess the comparative role of two treatment regimens Virechanakarma-yoga basti regimen and Yoga basti-uttarabasti regimen in the management of Vandhyatva with special reference to female infertility.
| Methods|| |
It was an open-label, comparative, and randomized trial. Study design approval and ethical clearance were granted by Institutional Ethical Committee (No. IEC/ACA/2016/32). And the trial was registered with clinical trials registry-India vide no. CTRI/2017/04/008387. All these participants were recruited from outpatient door and inpatient door of the National Institute of Ayurveda, Jaipur.
Patients of primary and secondary infertility aged between 18 and 40 years, infertility due to polycystic ovarian disease (PCOD), cervical factors (cervicitis, erosion, and improper production of cervical mucus) with at least one patient fallopian tube, having fit male counterpart in regards to fertility, patients fit for Virechana, uttarabasti and Basti and willing to participate in the study for a month were recruited in this study.
Patients having surgical factors, including fibroid uterus, cervical polyp, cervical stenosis, congenital anatomical defect, severe infection or chronic systemic diseases, malignancy, infertility due to tubal factors (if both tubes were blocked), and infertility due to peritoneal factors were not included in the study.
There was the clause of immediate withdrawal from the trial in observance of severe adverse reactions. Patients were also allowed to withdraw from the study without explaining any reason.
On screening visit, informed consents were obtained followed by general and systemic examinations, laboratory investigations, and ultrasonography. Laboratory investigations included hemoglobin%, total leukocyte count, differential leukocyte count, erythrocyte sedimentation rate, human immunodeficiency virus, hepatitis B surface antigen, venereal disease research laboratory test, random blood sugar, T3, T4, thyroid-stimulating hormone, mantoux test, routine and microscopic urine test, serum follicle-stimulating hormone (FSH), serum luteinizing hormone, serum progesterone, serum prolactin at baseline. Based on the baseline data, a total of 30 patients fulfilling the inclusion and exclusion criteria were registered for trial and divided randomly into two: Group A and B. Group A was subjected to Kashmaryadi ghrita Snehapana, Tilvakaghrita virechana (~20–40 ml) and Sansarjanakrama (graduated diet schedule). Yogabasti with Erandmooladi nirhuabasti (~480 ml) and Balataila anuvasana basti (~60 ml) was administered from 8th day after Virechana. In Group B, Yogabasti with Erandmooladi nirhua basti (~ 480 ml) and Balataila anuvasana basti (~60 ml) was administered for 8 days followed by Balataila uttarbasti (~5 ml) for 2 courses of 3 consecutive days with a gap of 2 days in between them. Details of intervention are given in [Table 1].
The primary outcome of the study was to assess conception and the secondary outcomes were to assess changes in menstrual parameters, cervical mucus, follicular study, and endometrial thickness. Pregnancy is the surest proof of ovulation; indirect testing for the detection of ovulation was also adopted. Mid-cycle mucus is the best clinical marker of ovulation on the 12th to 14th days and 21st to 23rd days of the menstrual cycle. In the study, ultrasonography was done from the 12th day up to maximum 18th day according to the condition of the follicle. To facilitate the statistical analysis of the efficacy of therapy, scoring system was adopted.
Patients visited for follow-up visits on day 14th and 22th days of cycle for Spinnbarkeit (SB) test and fern test, respectively after 2-month after the commencement of treatment. On follow-up visit, menstrual parameters were assess on scoring pattern, SB test, and fern test score assessed by modified Insler criteria scoring. Endometrial thickness, ovulation, and dominant follicle assessed by transvaginal ultrasonography. Urine pregnancy detection test and ultrasonography for the confirmation of pregnancy were done. No other concomitant medicine is given to these participants during the trial intervention and follow-up.
Analysis was done with the intention to treat. All the results were calculated by using Offline InStat GraphPad 3.1 software from www.graphpad.com visited on the date of February 23, 2018. For intragroup comparison of nonparametric data; “Wilcoxon matched-pairs signed-ranks test” and for parametric data “Paired-t-test” were used and the results were calculated in each group. For calculating the intergroup comparison, “Mann–Whitney Test” and “unpaired-t-test” were used and the results were calculated. All the statistical tests were interpreted as significant at 5% level (P < 0.05).
| Results|| |
A total of 35 patients were screened and out of them, 30 patients who were fit for trial were registered. There was no dropout or withdrawal during the trial or follow-up. The median age of these participants was 28 years (range, 20–36). No significant changes were observed at the end of therapy from baseline in any of the vital signs, i.e., pulse rate, body temperature, respiratory rate, and systolic and diastolic blood pressure. All these patients were previously treated with allopathic medications for infertility. Irregular menstruation was found in 15 patients. Abnormality in duration and amount of menstruation was in 19 patients. Pain during menstruation was felt by 25 patients. Pain during coitus was observed in 17 patients. 19 patients were nulligravida (cases of primary infertility) while 23 patients were nullipara. Infertility due to anovulation was found in 14 patients. Infertility due to unexplained reasons was in 12 patients and infertility because of cervical factor abnormalities was in 4 patients. Twenty-four patients were addicted either to coffee or tea.
Effect of therapy on primary outcomes measures
Total three patients conceived following follow-up, 2 patients from A group and 1 patient from B group conceived and live births were noted in all these three cases. Although statistically, the result was not significant [Table 2].
Effect of therapy on secondary outcomes measures
In Group A, there were statistically significant improvements in variables such as follicular study, SB test, amount of menstruation, interval in menstruation cycle, duration of menstruation, and dysmenorrhea and dyspareunia after the trial. There were statistically insignificant changes in endometrial thickness and fern test [Table 2]. In Group B, there were improvements in endometrial thickness, Fern test, SB test, amount of menstruation, duration of menstruation, dysmenorrhea with statistically significant results. There were statistically insignificant changes in follicular study, the interval in menstruation cycle and dyspareunia [Table 2]. On comparison, there was statistically insignificant difference between these two groups in primary and secondary outcomes [Table 3].
Safety and tolerability
No adverse events or abnormal laboratory results were noted during the trial or follow-up.
| Discussion|| |
The present study suggests that there is age-related decline in female fertility may be attributed to progressive follicular depletion and high incidence of abnormality in aging oocytes. Majority of patients were obese and suffering from polycystic ovarian disease (PCOD). This supports the fact that high BMI reduces the chances of conception in ovulatory women and also affects the outcome of the ovulation induction treatment. Most patients were having irregular menstruation, abnormality in duration and amount, abnormal interval in menstruation cycle, and pain during menstruation. These data explain disturbance in the function of Apana vayu which is responsible for proper Pravartana of Artava (normal menstrual and ovarian cycle). The menstrual cycle and ovarian cycle are interdependent because they are controlled by the hypothermic pituitary ovarian axis, i.e., under the control of hormones. Disturbed levels or functions of hormones affect the menstrual as well as ovarian cycle. So, the patients having anovulatory cycles generally have the complaints of oligomenorrhea or polymenorrhea. Pain during coitus was present in 17 patients which may cause lack of interest in coitus. There was a history of tuberculosis in four patients which suggest the anti-gonadotropic effect of Mycobacterium tuberculosis resulting in menstrual irregularities that may take place in active pulmonary tuberculosis. The interventions caused significant improvement in menstruation parameters, cervical mucus, follicular study, and endometrial thickness. On intergroup comparison, Virechana karma-yoga basti provided better improvement in all the menstruation parameters, SB test and follicular study in infertility patients. Yoga basti-uttarabasti group provided better improvement in dyspareunia, fern test, and endometrial thickness. On conception; groups A and B were statistically equally effective however more patients conceived in group A. Apanavayu is responsible for normal expulsion of Shukra (seminal fluid) and Artava. Margavarodha (obstruction in route), Dhatu kshaya (diminished tissues, muscle, bones) Avarana (obstacles), and Swanidanaprakopa (vitiation due to own causes) are the main reasons for Vata vitiation. For Avritaapanavayu (obstruction of a type of Vata dosha) the treatment advised are Agnideepak (increases digestive power), Sroto shodhana, (clear micro channels) Vata anulomaka (proper functioning of Vata dosha) and Pakvashaya shudhdhikaran (~ purification of the large intestine). In Vatavyadhi, snighdha (unctuous) and Mridu (soft) Virechana is indicated therefore in the present study Tilvakaghrita was selected which possess similar quality. Ghrita is Yogavahi (having property to achieve the virtue of other substances in which it may mix), Agnideepaka, rasayana (immune modulation), vrishya (aphrodisiac), vata pitta shamaka (Pacification of Vata and Pitta Doshas) and overcomes vitiated Kaphadosha due to Samskar anuvartanaguna (adopt quality of other substance). Virechana increases the activity of sperm and ovum Virechana is also effective in infertility and helpful in patient to conceive. The removal of Shrotoavrodha (obstruction in micro channels) and purification of Dhatu are essential factors for conception. Basti is considered as the half treatment of all diseases and main treatment for the vitiated Vata. Here Basti normalize the function of Apanavayu and remove the Srotoavrodha. Erandmooladi basti regulates the proper functioning of Apanavayu hence it regulates the Artava pravartana (~flow of menstrual fluid, formation of ovum). Uttarabasti is the specialized Basti, especially for Yoni vikara (diseases of female genital organs). Taila sneha-kalpana (~preparation of oily substances/drugs soluble in oily media) is the best treatment for the Ruksha (dryness) Vata dosha. It pacifies Vata dosha but never vitiates Kapha dosha and has Yoni shodhana (purification of the female genital organs) properties. Hence, in the present study, Bala taila uttarabasti was selected. Garbhashaya (uterus) uttarbasti affect the Artava vaha srotas (microchannels related to the female genital system) and stimulates the Srotas (microchannels) as well as the Beejagranthi (ovaries). By the stimulation of the ovary, the Sanga (obstruction) in the Beejagranthi is removed and Vata performs its two functions properly– Vibhajana (division), i.e., division in oocyte and proliferation of granulosa cells and responsible for the development of follicle along with Kapha and Pravartana (~secretion), i.e. rupture of the follicle which leads to ovulation. Kashmaryadi ghrita was used for Snehapana as it is described as Garbhadayoga (to give conception). Majority of drugs of Kashmaryadi ghrita and Balataila are having Madhura (sweet), Tikta (bitter) and Kashaya (astringnant) rasa dominancy, Ushnaveerya (~hot potency), Madhurvipaak (sweet after digestion), laghu (light), and Ruksha (dry) guna (quality). Kashaya and Madhura rasa, sheet veerya (cold potency) of Ghrita may increase the muscular strength of the reproductive system.
No adverse effect or complications was observed up to last follow-up suggesting it safe, affordable, nonsurgical, and effective and may be recommended for the management of infertility in females. Menstrual parameters were significantly improved suggests this therapy for menstrual irregularities in unmarried as well as married younger women. Only three patients conceived which the 10% of total patient population but results in secondary outcomes were significant. Studies on intrauterine insemination (IUI) success rate with controlled ovarian hyperstimulation estimate it between 14% to 18% in unexplained infertility. Success rate of timed intercourse (TI) and IUI after ovarian stimulation with CC or gonadotropins (FSH or human menopausal gonadotropin) with ovulation induction and luteal phase support were estimated 2.7% in CC/TI cycles, 8.2% in FSH/TI cycles, 10.3% in CC/IUI cycles, and 15.5% in FSH/IUI cycles., Thus, result in the present clinical trial work is in par with these published studies.
Considering the time-bound duration of the study with small sample size and limited resources for conducting this clinical trial, drawing concrete and precise conclusions would be premature. It is advised that Rasayana and Vajikaranaaushadhi (aphrodisiac medicine) should also be incorporated in future trials after completion of Panchakarma therapy to increase the efficacy of the treatment.
| Conclusion|| |
It is concluded that Treatment with Virechana karma-yoga basti regimen and Yoga basti-uttarabasti regimen was statistically equally effective in Vandhyatva (female infertility). These treatment modalities are safe, cheap, and effective in the management of female infertility.
Financial support and sponsorship
National Institute of Ayurveda Jaipur, Rajasthan.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]