Efficacy of Virechana,Shatpushpa Yapana Basti,Phalkalyan Ghrita Uttara Basti,Shatpuspa Taila Nasya along with Lakshmana Churna orally in the management of female infertility (Vandhytava) w.s.r. to low AMH - An open labelled single arm clinical trial

INTRODUCTION:-

Infertility is defined as not being able to get pregnant or conceive after one year or longer time period of unprotected vaginal intercourse.

The most common overall cause of female infertility is the failure to ovulate, which occurs in 40% of women with infertility issues.

Poor Ovarian Reserve (POR) indicates a reduction in the quantity of ovarian follicular pool in women of reproductive age group and it is an important cause of infertility due to failure to ovulate in many couples.

Anti Mullerian Hormone (AMH) is considered as a marker for the ovarian reserve, as it has a regulative function in the activation of folliculogenesis and has an influence on atresia rate.

In women, an AMH level can provide information about the fertility status and the ability to get pregnant. The term ovarian reserve describes the number and the quantity of  the remaining oocytes in the follicles.

According to Acharya Sushruta, there are four factors responsible for creation of Garbha i.e. Rutu (ovulatory period/ period for copulation), Kshetra (reproductive tract including uterus, fallopian tube, ovary), Ambu (nutritive fluid for fertilized ovum), Beeja (Shukra & Shonita i.e. sperm & ovum). Among these four factors low AMH can be considered as the deformity of Beeja i.e. Beejadusti. Beeja is the corestone of female reproductive process and in its absence conception cannot achieve despite of all other factors, here Beeja is taken as Antahpushpa i.e., ovum.

Rationale for selection of the topic

AMH level is indicative of ovarian response, its measurement becomes an inevitable criteria before IVF. Considering the high cost and possible complications of ART procedures, the unavoidable role of AMH as a superior candidate predicting ovarian reserve has been explored in various studies.

Therefore, uncertainty in the ART procedure outcome can be minimized to a greater extent. Reports suggest that patients with a diminished ovarian reserve have the only option of IVF with a donor egg.The occurrence of poor ovarian response in IVF ranges from10 to 20%.

The clinical symptoms observed in the infertility with low AMH resembles to Dhatukshayajanya Vandhyatva (infertility due to depletion of body tissues), that has been already explained in Ayurveda in Harita Samhita.

The role of an effective Ayurvedic treatment protocol to improve the AMH level to a satisfactory level to have a better response to ovarian stimulation for normal conception or IVF by own eggs, thereby opening a scope of an integrated medical approach. The present study is an attempt on the same

 AIM :-

To evaluate the efficacy of Virechana, Shatpushpa Yapana Basti, Uttara Basti with Phalakalyan Ghrita, Nasya with Shatapushpa Taila along with oral administration of Lakshmana Choorna in the management of female infertility (Vandhytava) due to low AMH.

Objectives:

To evaluate the effect of  trial drug in improving the AMH (Anti Mullerian Hormone) level.

To evaluate the effect of trial drug in improving the AFC (Antral Follicle Count).

 Materials and Methods

In this study there is only one group containing 15 patients and will be treated with in first month Virechana Karma will be done.In second month Shatpushpa Yapan Basti (7 days)will be done.In third month Phalkalyan Ghrita Uttarbasti (6 days) will be done.In forth and fifth month Shatpushpa Taila Nasya ( 7 days and will repeat this  for 2 consecutive ctyclcles) will be done along with Lakshamana Choorna orally for 5 month.

Results and Discussion:

Data generated during the above study will be presented in a systemic manner and shall be analysed statistically. The important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.

Side Effects: This drug has no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.