A Study to Evaluate the Safety and Effectiveness of PCO-NIL Capsules in Women with Polycystic Ovary Syndrome (PCOS)

A TOXICOLOGICAL AND PILOT CLINICAL EVALUATION OF PCO-NIL CAPSULE FOR ASSESSING ITS SAFETY AND THERAPEUTIC EFFICACY IN THE MANAGEMENT OF PCOS. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113695

Enrollment

Registered

2026-07-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Willing to participate after providing written informed consent Diagnosed with PCOS as per Rotterdam Criteria (2023), fulfilling at least two of the 3 criteria. following: Oligo-ovulation or anovulation (irregular or absent menstruation) more than 35 days between the cycle or less than 9 cycle per year Clinical or biochemical signs of hyperandrogenism (e.g., acne, hirsutism, elevated testosterone) Polycystic ovaries on ultrasound (more than 20 follicles or increased ovarian volume) Not currently taking any hormonal therapy or Ayurvedic medications for PCOS (for at least4 6 weeks prior to study)

Exclusion criteria

Exclusion criteria: Other known endocrine disorders, such as - Thyroid dysfunction (hypo-/hyperthyroidism), Type 1 or 2 Diabetes Mellitus Pregnancy or lactation endometriosis, or uterine abnormalities Hb less than 8 gm% Use of hormonal contraceptives, insulin sensitizers (like metformin), or corticosteroids within the last 6 weeks Known hypersensitivity or allergy to any component of the tablet formulation Severe systemic illness or psychiatric conditions that could interfere with study participation or compliance Participation in any other clinical trial within the last 3 month

Design outcomes

Primary

Measure	Time frame
Reduction in Ovarian cyst size (8 weeks)Timepoint: menstrual regulation, hormonal balance, ovulation improvement	—

Secondary

Measure	Time frame
menstrual regulation, hormonal balance, pcos symptom relifeTimepoint: Total Duration BT-0th day DT- 4th week AT- 12th week; menstrual regulationTimepoint: PCOS Symptom Reduction, Improved Reproductive Health;Regulation menstrualTimepoint: Ovulation Improvement Hormonal Balance PCOS Symptom Reduction Improved Reproductive Hea;nilTimepoint: nil	—

Countries

India

Contacts

Public ContactDr Mauli Vaishnav

Parul University

mauli.vaishnav36886@paruluniversity.ac.in9589788336

Outcome results