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Clinical Trials/CTRI/2024/06/069265
CTRI/2024/06/069265
Not yet recruiting
Phase 2

Single Centric Non Randomized Open Clinical trial Phase II in Soothaga Vaayu (PCOD) with Siddha Medicine Soosika Chooranam among patients attending OPD at Government Siddha Medical College Hospital, Chennai.

Government Siddha Medical College, Chennai1 site in 1 country40 target enrollmentStarted: September 2, 2024Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Government Siddha Medical College, Chennai
Enrollment
40
Locations
1
Primary Endpoint
Regulation of menstrual cycle and harmonal profile.

Overview

Brief Summary

PCOD is a multifactorial and polygenic condition, manifested by amenorrhea, hirsutism and obesity associated with enlarged polycystic ovaries.This complex endocrine disorder occurs at a frequency of 11.2% in women of reproductive age group.It was first described by Stein and Leventhal in 1935 and is linked with anovulation. It is now recognized as a common, heterogeneous heritable disorder affecting women throughout their lifetime. In Siddha system of Medicine, there are unique combinations of medicines which have solutions to the present scenario of PCOD. One such combination is SOOSIKA CHOORANAM which will be more effective and reliable. The method of preparation of the medicine is easy and the raw drugs are also easily available.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
15.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • a.Female aged between 15-45 years (24).
  • Based upon the presence of any two of the following Rotterdam criteria 1.Oligo / Anovulation 2.Hyperandrogenism (Clinical/Biochemical) 3.Polycystic ovaries (unilateral/bilateral) c.
  • Seeking treatment for PCOD induced infertility.

Exclusion Criteria

  • Under any other serious systemic illness.

Outcomes

Primary Outcomes

Regulation of menstrual cycle and harmonal profile.

Time Frame: 3 months

Secondary Outcomes

  • Disappearance/reduction in the size or number of cysts.(3 months)

Investigators

Sponsor
Government Siddha Medical College, Chennai
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr G Sanjana

Government Siddha Medical College,Chennai.

Study Sites (1)

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