Clinical research study of Soothaga vaayu leghium and Veezhi ennei (Internal medicines)in the treatment of Garpa vaayu (polycystic ovarian disease)

Phase 3

Recruiting

• Conditions: GARPA VAAYU(POLYCYSTIC OVARIAN DISEASE)

• Registration Number: CTRI/2014/01/004282
• Lead Sponsor: AYOTHIDOSS PANDITHAR HOSPITAL

Brief Summary

It is a single, non-randomized, open-label trial to determine the efficacy and safety of SOOTHAGA VAAYU LEGHIUM (Prepared with 22 herbal constituents and one mineral constituent, milk ghee and honey)  and VEEZHI ENNAI (prepared with 15 herbal constituents and castor oil and ghee) in patients with Garpa vaayu (polycystic ovarian disease.) In this trial 40 patients will be recruited. 70 ml of Veezhi ennai will be administered orally before food as a single dosage for the first three days of every menstrual cycle for the consecutive three cycles to induce purgation. In addition 6 gm of Soothaga vaayu leghium will be administered orally twice a day after food for a period of 15 days in each menstrual cycle for the consecutive three cycles.During this trial period all the study related data will be recorded and documented in a separate trial master file for each patients. During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance department in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety and efficacy parameters will be recorded in CRF.After completion of the trial all the study related data will be analysed statistically.The out come of the  trial will be published in Indian Journal of Medical Research.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Last Update Posted: 2014-03-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• •Age: 16-35 years •Patient having the symptoms of irregular menstruation •Oligomenorrhoea (or) Amenorrhoea (or) Dysmenorrhoea •Patient willing to take USG pelvis •Patient willing to undergo routine blood investigation.
• •USG pelvis showing polycystic ovaries •Patient willing to undergo purgation as a preparatory part of treatment •Patient willing to participate in trial and signing in consent form.

Exclusion Criteria

•H/O hypertension •H/O diabetes mellitus •H/O cardiac disease •Pregnancy and lactation •H/O thyroid dysfunction •H/O recent hormone therapy (Past one year).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assessed by the improvement in the score of irregular menstruation (Intermenstrual period& duration of bleeding)	pre study screening and after treatment

Secondary Outcome Measures

Name	Time	Method
Changes in the polycystic swellings of the ovaries in USG pelvis and reduction of other clinical symptoms	pre study screening and after treatment

Trial Locations

Locations (1)

AYOTHIDOSS PANDITHAR HOSPITAL; 🇮🇳 Kancheepuram, TAMIL NADU, India

AYOTHIDOSS PANDITHAR HOSPITAL

🇮🇳Kancheepuram, TAMIL NADU, India

DR C PRATHEEPA

Principal investigator

8056903166

pratheepa.bsms@gmail.com