Placebo controlled Randomized Clinical Trial to assess the effectivity of Kalingathi Ennai in improving ovulation in patients with polycycstic ovary syndrome who are undergoing treatment with Clomiphene citrate or Letrozole

Phase 3

Conditions: Polycystic Ovary Syndrome (Soothaga Vaayu)

Registration Number: SLCTR/2024/006

Lead Sponsor: nit of Siddha Medicine, Faculty of Applied Science

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1. Subfertile women between 20 to 45 years with PCOS. (Subfertility defined as - Inability to conceive after 1year of regular unprotected intercourse)

2. PCOS will be diagnosed according to the International Evidence-Based Guideline for the Assessment and Management of Polycystic Ovary Syndrome 2018. Monash University: Melbourne, Australia; Sonographic appearance of polycystic ovaries and one of the following criteria: Infrequent cycles (formerly referred to as oligomenorrhoea) or amenorrhoea; hyperandrogenism (clinical or laboratory).

3. Women who have been under any form of treatment (Allopathic or Siddha or Ayurvedic or Unani or Homeopathic or Traditional Chinese) for PCOS or subfertility within the three previous months will be recruited after three months (washout time) without taking any medication for PCOS or subfertility.

Exclusion Criteria

1.Women with inherited disorders such as Cushing syndrome, hyperprolactinemia, untreated hypothyroidism, congenital adrenal hyperplasia, or with an androgen-secreting ovarian/adrenal tumour and those taking a corticosteroid, antiepileptic or antipsychotic drugs.

2.Women who are not suitable for pregnancy (Uncontrolled Diabetic Mellitus, Uncontrolled Hypertension, etc) and women with Body Mass Index >30.

3.Women with tubal factor infertility and women whose partners have azoospermia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ovulation - It will be confirmed by Serum Progesterone 20 nmol/L or more in the mid-luteal phase [Day 21st of the menstrual cycle (after treatment of the first to sixth menstrual cycle) Every month, until positive results are achieved or until six months after treatment.]<br>

Secondary Outcome Measures