A Study to Test How Safe and Effective Ovacare Forte Tablets Are in Improving Periods, Metabolism, and Fertility in Women with PCOS

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Ovacare Forte Tablets for Menstrual Regulation, Metabolic Health, and Fertility in Women with Polycystic Ovarian Syndrome. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/05/087755

Enrollment

300

Registered

2025-05-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Intervention1: Treatment Arm: Ovacare Forte tablets (Formula A and Formula B) Intervention2: Treatment Arm: Ovacare Forte tablets Formula A: 1000 mg Formula B: 1.2 g Both Formula A and Formula B tab

Eligibility

Inclusion criteria

Inclusion criteria: Patients meeting all the following criteria will be eligible for the study: 1. Female patients aged between 18 to 40 years (both inclusive). 2. Subjects with HbA1c greater than or equal to 6.5 percent 3. Clinically diagnosed case of PCOS, following the Modified Rotterdam Criteria, requiring two of the three symptoms as follows: oligo-anovulation, hyperandrogenism, and/or polycystic ovarian morphology PCOM. 4. BMI less than 35 kg per m2. 5. Willingness to participate in the study by providing written informed consent, follow study procedures and comply with lifestyle and dietary modifications.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will not be eligible for the study: 1. Subjects with BMI greater than or equal to 35 kg per m2. 2. Subjects with HbA1c greater 6.5 percent. 3. Subjects with comorbidities such as diabetes, hypertension, asthma and cardiovascular diseases. 4. Subjects with endocrine disorders except PCOD. 5. Intake of over-the-counter weight loss agents, centrally acting appetite suppressants, or prior surgery for obesity in the previous three months. 6. Subjects consuming any nutraceutical agents for the past 1 month including myoinositol. 7. Subjects with any psychiatric or neuronal illness. 8. Subjects with evidence of malignancy. 9. Pregnant and lactating women. 10. Subjects with hypersensitivity to any ingredients of the Investigational Products. 11. Subjects who have participated in any other clinical trial within the last 3 months. 12. Any other condition that the Principal Investigator thinks may jeopardize the study.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and efficacy of Ovacare Forte tablets in comparison to placebo in regulating menstrual cycles, improving metabolic health, and enhancing fertility in women with polycystic ovarian syndrome (PCOS).Timepoint: Baseline to Visit 5	—

Secondary

Measure	Time frame
To assess the impact of Ovacare Forte on PCOS-related symptoms such as acne and hirsutismTimepoint: Baseline, Visit 3, Visit 4, Visit 5;To evaluate improvements in quality of life using validated Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQoL-47)Timepoint: Baseline to Visit 5	—

Countries

India

Contacts

Public ContactAdarsh Karanth

Meyer Organics Private Limited

medicalservices@meyer.co.in9866951573

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026