Randomized controlled clinical trial to study the efficacy of the Shivlingi Beeja (Bryonia laciniosa) churna in the manegement of PCOS

“RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY OF THE SHIVLINGI BEEJA (BRYONIA LACINIOSA ) CHURNAINTHE MANEGEMENT OF PCOS.”

Introduction:

PCOS is one of the most common reproductive endocrinological disorder with a broad spectrum of clinical manifestations affecting 8 to 10%1.2 in reproductive age group. In PCOS ovaries fail to develops a mature egg and generate only multiple immature follicles with increase in ovarian size represented by oligomenorrhoea or amenorrhea, hyperandrogenism (Clinical Or Biochemical) and polycystic ovaries in USG which is diagnosed by Rotterdam Criteria (2003)3. The pathogenesis of PCOS is still largely unknown and until now medical care of these subjects has been limited to symptomatic control of cosmetic concerns, menstrual dysfunctions and infertility. Women with the syndrome are frequently insulin resistant, independent of obesity14. In these regards, much of the data supports that insulin resistance and the associated hyperinsulinemia plays an important role in PCOS. Insulin has direct effect on ovarian steroidogenesis stimulating androgen synthesis in theca cells leading to the syndrome7,15.

In Ayurvedic classics, PCOS maybe consider under various headings as Artavakshaya, Anartava, Nashtartava, Granthibhoota Artavdushti, Vandhyatva Yonivyapada, and Santarpanottha strotodushti. Pushpaghni Jataharini described in Kashyapa Samhita Khilsthana is the entity which is found more resembling with symptoms of PCOSamongst the others5.

Pushpaghni represents with typical features that includes destruction of Pushpa withregular menstruation, appearance of facial hair and obesity9.

PCOS can be considered as a condition manifested due to Mithyachara, Pradushtartava Beeja Dosha4.It may be term as Vata Kaphaja artva dushti.It is a Santarpanottha vikara withSanga, Avarana and Siragranthi form of pathogenesis. As the pathogenic factors involved in PCOS are Vata and Kapha Doshas Rasa and Meda – Dushyas, Artavavaha Strotas, Jatharagni and Dhatvagnimandya and will needVatakaphaghna and Rasayan Chikitsa as one of theway for sampraptibhanga.

Currently the standard care treatment for women with PCOS ranges from lifestyle modifications to pharmacological interventions including Anti androgens (Spironolactone, Flutamide), Insulin lowering agents (Metformin, Thiazolidine)8 and Oral Contraceptives as a single or combined17. Though effective, they do not abolish the basic problem and treatment is also associated with various adverse effects such as irregular menstruation, gastrointestinal disturbances, weight gain.

Considering all above points from various research papers found that “Shivlingi beeja” working on male as well as female infertility. Scientific research need was expressed by various authors in their review articles. As per data present role of Shivlingi beeja was studied on male rats, which shows good results. Every paper says it works on females also but such research is not done. As per tribes of Pakalkot these seeds are to be use in females those wants to concive.10 So it has been decided to work on Shivlingi beeja. According to Ayurvedic texts Shivlingi beeja has properties like uterine tonic, Rasayana, anti-obesity and antidiabetic properties. So with the hypothesis on the basis of available literature, Herbal or Herbomineral medicines according to Ayurveda can have great benefit in PCOS to abolish basic problem without or minimal adverse effect of conventional drugs. So it is decided to study the effect of the Shivlingi beeja (bryonia laciniosa ) churna in PCOS.

  Purpose of the study:

Purposeof present study is to Study theefficacy ofShivlingi beeja churna vatiin patients with PCOS.

 Expected duration of study and expected number of participants:

140 participants and each participant will be studied for 3 months.

Sr.No.

 Group A

Group B

|1.

Drug

Shivlingi beeja churna

Tab. Metformin

|2.

Dose

3 gms OD

Luke warm water

500 mg OD

|3.

Kala

Pragbhakta

Pragbhakta

|4.

Duration of therapy

3 months

3 months

|5.

Route of Administration

Oral

Oral

|6.

Follow up

Monthly

Monthly

Criteria of Assessment:

Assessment will be done based on following criteria before and after the treatment.

 Subjective criteria:

Menstrual cycle:

Interval between 2 cycles.

|Hirsutism19,20,21:

Modified Ferrimen and Galley Visual Scoring System*

Objective

Sr.Insulin(F)7,14,15

|BSL(F)14

|Insulin  Resistance

|Sr.Testesterone7,14,15

|PCOS Pattern and Ovarian Volume

|BMI (kg/m2 )18

Observational criteria:

1: Grading for interval between two menstrual cycles 2: Assessment of Hirsutism with Modified Ferriman and Galley Visual Scoring System19. 3: Assessment of variable BMI(Kg/m2)18 4: For Variable Sr. Insulin(F) 5: For variable Sr. Testesterone 6: For Variable BSL(F) 7: For Variable Ovarian Volume 8: For PCOS Pattern (Present or Absent)