Actively Recruiting

Phase 1
Age: 18Years - 40Years
FEMALE
ID07399535

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

Led by Jinnah Postgraduate Medical Centre · Updated on 2026-02-10

116

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a new herbal formulation called Melats P for women with Polycystic Ovarian Syndrome (PCOS), a common metabolic disorder affecting women of childbearing age. PCOS causes problems such as hormonal imbalance, irregular ovulation, infertility, obesity, excessive hair growth, acne, and metabolic issues like insulin resistance and type 2 diabetes. This study aims to compare the herbal formulation against conventional treatment and their combination in improving infertility and menstrual cycle regulation in women with PCOS. Participants will be divided into three groups: one receiving the herbal formulation Melats P at 500 mg twice daily, another receiving Metformin XR 750 mg twice daily, and a third group receiving both treatments together. Each treatment is given for 4 months. The herbal formulation contains plant-based ingredients chosen for their potential to restore hormonal balance and improve ovulation with fewer side effects compared to standard drugs. The study includes a phase 1 clinical trial design with randomized assignment and no masking. During the study, participants will have their menstrual cycle regulation monitored from baseline to 4 months. Additional assessments include blood tests for hormones such as follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone, as well as metabolic measures like glycated hemoglobin (HbA1c), fasting insulin levels, insulin resistance (HOMA-IR), and body weight. These evaluations will occur at the start and after 4 months of treatment to assess safety and effectiveness. The total participation duration is approximately 4 months, with the study scheduled to start in February 2025 and end by March 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female subjects of reproductive age (18-40 years).
  • Diagnosis of polycystic ovary syndrome (PCOS) confirmed by a clinician.
  • Insulin resistance with HOMA-IR greater than 2.00.
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women.
  • Known Cushing's syndrome.
  • Late-onset congenital adrenal hyperplasia.
  • Androgen-secreting tumors.
  • Uncontrolled thyroid disease.
  • Hyperprolactinemia.
  • Diabetes mellitus.
  • Uncontrolled hypertension.
  • Other cardiovascular diseases.
  • Acute or chronic infections.
  • Any known malignancy.
  • Impaired renal function with serum creatinine greater than 1.5 times upper limit of normal.
  • Impaired liver function with serum ALT equal to or greater than 2.5 times upper limit of normal.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 months

Participants receive assigned medication—herbal formulation, metformin, or both—twice daily as treatment for PCOS.

Regular visits to monitor safety and effectiveness

Trial Site Locations

Total: 1 location

1

Jinnah Postgraduate Medical Centre

Karachi, Sindh, Pakistan

Actively Recruiting

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Research Team

S

Saba Zubair, PhD Scholar

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome.

Helena J Teede, Marie L Misso, Michael F Costello...

https://pubmed.ncbi.nlm.nih.gov/30052961

A comprehensive review of clinical studies with herbal medicine on polycystic ovary syndrome (PCOS).

Arezoo Moini Jazani, Hamidreza Nasimi Doost Azgomi, Alireza Nasimi Doost Azgomi...

https://pubmed.ncbi.nlm.nih.gov/31741280

A comparison of the effects of cinnamon, ginger, and metformin consumption on metabolic health, anthropometric indices, and sexual hormone levels in women with poly cystic ovary syndrome: A randomized double-blinded placebo-controlled clinical trial.

Marsa Dastgheib, Reza Barati-Boldaji, Niki Bahrampour...

https://pubmed.ncbi.nlm.nih.gov/36523331