A Clinical trial to study the effect of the drug Soothaga Chooranam in patients having S Poly Cystic Ovarian Syndrome (Soothaga Vaayu)

Phase 2

Not yet recruiting

• Conditions: Polycystic ovarian syndrome,

• Registration Number: CTRI/2021/11/038124
• Lead Sponsor: Government Siddha Medical College

Brief Summary

This is a single non randomized open clinical trial to study the safety and efficacy of the Soothaga Chooranam. The trial drug is given 1250-1500 mg twice a day for 48 days.Clinical trial is conducted after conducting pre clinical toxicity study. The trial drug Soothaga Chooranam is mentioned in Sarabendirar Siddha Maruthuva Sudar. During the trial all the study related date will be recorded and documented. After the completion of trial all the data will be analysed statistically.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-11-17
• Study Start: 2021-11-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Unmarried and married women Married women with primary infertility H/o Amenorrhea H/o Irregular menstruation H/o Ovulation related infertility H/o Oligomenorrhoea H/o Poly cystic ovary in ultra sound (unilateral/ bilateral).

Exclusion Criteria

H/o Hyperthyroidism /hypothyroidism H/oCongenital uterine defects H/o Pituitary/adrenal disorders H/o Hemorrhagic cyst H/o Chocolate cyst H/oAny serious systemic illness H/o Tuberculosis of the ovary and uterus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is mainly assessed by regulation of menstrual cycle hormonal profile and ovulation Reduction/disappearance in the size and number of cyst in ovary	It is mainly assessed by regulation of menstrual cycle hormonal profile and ovulation Reduction/disappearance in the size and number of cyst in ovary

Secondary Outcome Measures

Name	Time	Method
Secondary outcome is assessed by comparing the safety parameters before and after treatment	48 days

Trial Locations

Locations (1)

Arignar Anna Government Hospital of Indian Medicine; 🇮🇳 Chennai, TAMIL NADU, India

Arignar Anna Government Hospital of Indian Medicine

🇮🇳Chennai, TAMIL NADU, India

Dr Boomathi S

Principal investigator

9095909539

boomathisozhanambi@gmail.com