A clinical trial of ATTATHI CHOORANAM in the management of RAKTHA SOORAI VAAYU (POLY CYSTIC OVARIAN SYNDROME)

Phase 2

Not yet recruiting

• Conditions: Polycystic ovarian syndrome,

• Registration Number: CTRI/2019/05/019119
• Lead Sponsor: Government Siddha Medical College and Hospital

Brief Summary

The study is a prospective open labelled, non-randomised, phase II clinical trial to determine the efficacy and safety of ATTATHI CHOORANAM in patients with RAKTHA SOORAI VAAYU ( POLY CYSTIC OVARIAN SYNDROME). The trial drug is processed from raw herbs and mineral. In this clinical trial to be held at GSMC, Palayamkottai, 40 patients (20 in OPD + 20 in IPD) will be recruited and the trial drug will be administered at the dose of 40 mg/ Kg/ BW TDS A/F along with Honey or ghee as adjuvant for a period of 48 days. All the study related data will be recorded and documented in a separate file for each patients. In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patient will be given in OPD, GSMC, Palayamkottai. During this trial all the efficacy and safety parameters will be recorded in the CRF. After completion of trial all the study related data will be analysed statistically.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-14
• Last Update Posted: 2019-09-05

Recruitment & Eligibility

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

Inclusion Criteria

• Marital Status : Married / Unmarried II.
• Symptoms -Irregular menstruation, oligomenorrhoea (or) amenorrhoea (or) dysmenorrhoea (or) dysfunctional uterine bleeding -Hirsuitism and obesity III.
• Patient willing to take USG pelvis IV.
• Patient willing to undergo routine blood investigation V.
• USG pelvis showing polycystic ovaries VI.
• Patient willing to participate in trial and signing in consent form.

Exclusion Criteria

• History of recent hormone therapy (within one year) II.
• Lactating mother.
• History of renal disease V.
• History of Liver diseas VI.
• Uterine anomalies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of RAKTHA SOORAI VAAYU and evaluation of the therapeutic efficacy of Attathi chooranam. It is assessed by the improvement in the score of irregular menstruation (Intermenstrual period & duration of bleeding) before and after treatment.	48 days

Secondary Outcome Measures

Name	Time	Method
Changes in the polycystic swellings of the ovaries in USG pelvis and reduction of other symptoms.	48 days

Trial Locations

Locations (1)

Goverment Siddha Medical College and Hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Goverment Siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

Rasenthiran Sasvatha

Principal investigator

8883955520

sasrajenthiran@gmail.com