Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome (PCOS)

February 6, 2026 updated by: Saba Zubair, Jinnah Postgraduate Medical Centre
Polycystic Ovarian Syndrome (PCO) is a metabolic disorder that afflicts the women of childbearing age. An approximate of 5-10% women are the victim of this disorder. PCOS is a leading cause of infertility in females these days and is characterized by Hyperandrogenism, Chronic Anovulation, Impaired fertility, obesity, Hirsutism, Acne, Obesity, Metabolic disturbances (dyslipidemias, Hyperinsulinemia, insulin resistance, and type- 2 diabetes), and Endometrial Hyperplasia. This study will test a combination of herbal medications (Melats P) in women with PCOS to determine which works best to overcome infertility.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Polycystic Ovarian Syndrome is a point of concern these days in female population around the world.The patients feel psychological and mentally unhealthy. PCO effects around 6- 14% of women worldwide. PCOS is characterized by hormonal dis-regulation and hyperinsulinemia. Improvements in sex hormones and insulin sensitivity in PCOS women, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS Commonly prescribed treatment for PCOS include oral contraceptives (OCPs), metformin, pioglitazone, estrogen, GnRH agonist, myo-inositol, letrozole and clomiphene citrate. Despite their effectiveness in symptom relief and ovulation induction, these treatments are associated with adverse effects including weight gain, cardiac issues, lactic acidosis, dysmenorrhea, and abdominal discomfort (Hussain et al., 2022). Given the limitations of conventional drugs, Herbal therapies are gaining attention for their multi-targeted ability to restore natural hormonal balance, improve ovulation and offer symptom relief with minimal side effects (Hussain et al., 2022). In this context, the present study is designed to explore the therapeutic benefits of a novel polyherbal formulation that includes Momordica charantia L., Linum usitatissimum, Symplocos racemose bark, Allium cepa L., Tribulus terrestris, and eggshell. These ingredients were selected based on their various pharmacological properties that are relevant to the pathophysiology of PCOS. This study will evaluate the safety and effectiveness of Melats P in achieving a successful menstruation regulation in PCOS women.We will recruit 3 groups , First group with conventional treatment (Metformin ) , Second with Alternative medicine having a herbal Formulation ( Melats P) and Third group patients will receive both Conventional (Metformin) and Herbal Formulationn (Melats P).

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Jinnah Postgraduate Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female subjects of reproductive age (18-40 years).
  • Subjects with a diagnosis of polycystic ovary syndrome (PCOS) confirmed by clinician diagnostic criteria.
  • Subjects with insulin resistance defined as HOMA-IR > 2.00.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Subjects with known Cushing's syndrome.
  • Subjects with late-onset congenital adrenal hyperplasia.
  • Subjects with androgen-secreting tumors.
  • Subjects with uncontrolled thyroid disease.
  • Subjects with hyperprolactinemia.
  • Subjects with diabetes mellitus.
  • Subjects with uncontrolled hypertension.
  • Subjects with other cardiovascular diseases.
  • Subjects with acute or chronic infections.
  • Subjects with any known malignancy.
  • Subjects with impaired renal function (serum creatinine > 1.5 × ULN).
  • Subjects with impaired liver function (serum ALT ≥ 2.5 × ULN).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Herbal formulation treated group
Herbal formulation 500 mg twice daily for 4 months in PCOS patients
Drug: Herbal Formulation
Herbal Formulation 500mg twice daily for 4 months in PCOS patients
Other Names:
  • Melats P
Active Comparator: Metformin XR treated group
Metformin XR 750 mg twice daily for 4 months in PCOS patients
Drug: Metformin XR
Metformin XR 750mg twice daily for 4 months in PCOS patients
Other Names:
  • Glucophage
Experimental: Adjunct Group
Herbal formulation 500 mg and Metformin XR 750 mg twice daily for 4 months in PCOS patient
Drug: Metformin 750 mg and herbal formulation 500 mg
Herbal formulation and Metformin twice daily for 4 months in PCOS patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regulation of Menstrual Cycle
Time Frame: Baseline to 4 months
Improvement and restoration of regular ovulatory menstrual cycles ( cycle length 21-35 days) after 4 months of treatment, assessed through menstrual history and ultrasonographic confirmation of ovulation. Ovulation confirmed by transvaginal ultrasonography, defined by the presence of a dominant follicle followed by follicular rupture during the treatment period.
Baseline to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Follicle-Stimulating Hormone (FSH) Levels
Time Frame: Baseline and after 4 months
Change in serum follicle-stimulating hormone (FSH) concentration measured using standard laboratory assays. Unit of Measure: mIU/mL, Normal Range: Women (Follicular Phase): 3.5 - 12.5 , Women (Ovulation Phase): 4.7 - 21.5, Women (Luteal Phase): 1.7 - 7.7
Baseline and after 4 months
Serum Luteinizing Hormone (LH) Levels
Time Frame: Baseline and after 4 months
Change in serum luteinizing hormone (LH) concentration measured using standard laboratory assays. Unit of Measure: mIU/mL, Normal Range: Women (Follicular Phase): 1.9 - 9.2, Women (Ovulation Phase): 6.1 - 49.1, Women (Luteal Phase): 1.3 - 10.8
Baseline and after 4 months
Serum Testosterone Levels
Time Frame: Baseline and after 4 months
Change in serum testosterone levels measured using standard laboratory assays. Unit of Measure: ng/mL, Normal Range: 18-49 years: 0.084-0.481
Baseline and after 4 months
Glycated Hemoglobin (HbA1c) Level
Time Frame: Baseline and after 4 months
Change in glycated hemoglobin (HbA1c) percentage measured using standardized laboratory methods. Unit of Measure: %, Normal Range: Normal <5.6%, Prediabetes: 5.7% - 6.4%, Diabetes: 6.5% or higher
Baseline and after 4 months
Fasting Serum Insulin Concentration
Time Frame: Baseline and after 4 months
Change in fasting serum insulin concentration measured using standard laboratory assays. Unit of Measure: µIU/mL, Normal Range: 2 to 25
Baseline and after 4 months
HOMA-IR
Time Frame: Before and after 4 months
HOMA-IR will be calculated before and immediately after 90-day treatment. HOMA-IR is calculated using the following equation: HOMA-IR = fasting plasma glucose in mmol/L×fasting insulin in μU/ml/22.5.
Before and after 4 months
Body Weight
Time Frame: Baseline and after 4 months

Change in body weight measured using a calibrated weighing scale. Unit of Measure:

kg
Baseline and after 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of quality of life via Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL)
Time Frame: Before and after 4 months

The Polycystic Ovary Syndrome Quality of Life Scale (PCOSQOL) is a disease-specific questionnaire used to assess the impact of polycystic ovary syndrome on quality of life. It evaluates five domains: Emotions (8 items), Body Hair (5 items), Weight (5 items), Infertility Problems (4 items), and Menstrual Problems (4 items). Cronbach's alpha were above 0.7 when the PCOSQL was validated (Jones et al., 2004). It has 26 items and uses a 7-point Likert-type scale.

Scale Range:

Minimum value: 1 Maximum value: 7

Lower scores indicate decreased quality of life, while higher scores indicate improved quality of life.
Before and after 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Postgraduate Medical Centre

Investigators

  • Principal Investigator: Saba Zubair, PhD scholar, University of Sindh Jamshoro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2025

Primary Completion (Estimated)

February 22, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO.F.2-81/2024-GENL/101/JPMC (Other Identifier: Jinnah Postgraduate Medical Centre)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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