A Pilot Clinical study of Siddha Medicine in the treatment of Pen Maladu (Female Infertility)

Phase 2/3

Not yet recruiting

• Conditions: Pen Maladu (Female Infertility)

• Registration Number: CTRI/2017/03/008067
• Lead Sponsor: National Institute of Siddha

Brief Summary

It is a single, non randomized, open label trial to determine the efficacy and safety of Siddhathi Ennai (Prepared from herbal constitutents) and Vediuppu Chunnam (Prepared from herbo mineral constitutents) in patients with Pen maladu (Female infertility).

In this trial 10 patients will be recruited and the trial drug will be administered. Siddhathi Ennai 10ml OD dose at morning oral route 3 days duration and Vediuppu Chunnam 500mg BID dose oral route 96 days duration.

During this trail period all the study related data will be recorded and documented in a page 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 the CRF. After completion of the trial all the study related data will be analysed statistically. The out come of this trial will be published in Indian Journal of Medical Research.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-17
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Female who doesn’t have chance of conception for 1 year after Marriage with frequent unprotected sexual intercourse.
• Patient willing to undergo USG, Follicular study, Hormonal assay &Routine blood investigation.

Exclusion Criteria

• Endometriosis 2.
• Uterine Malformation 3.
• Any Major systemic illness [diabetes, hypertension, heart failure, renal failure..] 4.
• Genito urinary tuberculosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Enabling the patient to conceive	PRE STUDY SCREENING AND AFTER | TREATMENT

Secondary Outcome Measures

Name	Time	Method
1. Attain normal regular menstrual cycle	2.Restoration of Follicular maturation

Trial Locations

Locations (1)

National Institute of Siddha; 🇮🇳 Kancheepuram, TAMIL NADU, India

National Institute of Siddha

🇮🇳Kancheepuram, TAMIL NADU, India

Dr S Yavanarani

Principal investigator

04422381314

dr.yavana25@gmail.com