Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome (NCT07399535) | Clinical Trial Compass
CompletedPhase 1
Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome
Pakistan116 participantsStarted 2025-02-22
Plain-language summary
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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.