Herbal combination treatment for infertility and metabolic symptoms in women with PCOS
Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome
This trial will test whether a novel combination of herbal medicines, alone or with metformin, can help improve fertility and insulin resistance in women aged 18–40 with PCOS and HOMA-IR > 2.0.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Jinnah Postgraduate Medical Centre Government |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT07399535 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study at Jinnah Postgraduate Medical Centre tests a polyherbal formulation (Melats P) that includes Momordica charantia, Linum usitatissimum, Symplocos racemosa bark, Allium cepa, Tribulus terrestris, and eggshell, given alone or with metformin XR. Participants are women 18–40 years with clinician-diagnosed PCOS and insulin resistance (HOMA-IR > 2.00). Arms include the herbal formulation, metformin XR, and a combination of metformin 750 mg with herbal formulation 500 mg, with monitoring for reproductive and metabolic responses as well as safety and tolerability. As a Phase 1 effort, the emphasis is on early safety, tolerability, and signals of benefit for ovulation, fertility-related outcomes, and insulin sensitivity.
Who should consider this trial
Good fit: Women aged 18–40 with clinician-confirmed PCOS and insulin resistance (HOMA-IR > 2.00), who are not pregnant or lactating and who meet the listed medical exclusion criteria, are the intended participants.
Not a fit: Women with diabetes, significant liver or kidney impairment, hormone-secreting tumors, uncontrolled thyroid disease, or who are outside the 18–40 age range are unlikely to benefit or be eligible for this trial.
Why it matters
Potential benefit: If successful, this approach could offer a better-tolerated herbal option or adjunct to improve ovulation, fertility outcomes, and insulin resistance in women with PCOS.
How similar studies have performed: Some small trials of individual herbal agents and of metformin have shown improvements in ovulation and insulin sensitivity, but high-quality evidence for this specific polyherbal combination is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Karachi, Sindh
- Jinnah Postgraduate Medical Centre — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Saba Zubair, PhD scholar — University of Sindh Jamshoro
- Study coordinator: Saba Zubair, PhD Scholar
- Email: saba.zubair1@gmail.com
- Phone: +923313613089
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.