Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome (NCT04120597) | Clinical Trial Compass
CompletedPhase 1/2
Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome
China126 participantsStarted 2019-12-23
Plain-language summary
Polycystic ovary syndrome is the most common endocrine and metabolic disorder in gynecology. Traditional Chinese medicine has a good clinical effect in the treatment of PCOS. We intend to conduct this trial in strict accordance with the requirements of evidence-based medicine, through a multi-center, randomized, controlled study, using a double-blind, randomized, placebo-controlled study design method to clarify that Zishen Qingre Lishi Huayu Recipe restores spontaneous ovulation in PCOS patients. The overall efficacy of improving the characteristics of Kaohsiung and glucose and lipid metabolism is optimal, and high-level evidence-based evidence is obtained to form a diagnosis and treatment plan for promotion.
Who can participate
Age range
20 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
. Diagnosed as PCOS patients, the diagnostic criteria are the Rotterdam criteria. All subjects must have: no ovulation, combined with polycystic ovarian or / and hyperandrogenism.
. Age: 20 to 40 years old, no maternity requirements.
. Willing to be treated according to the treatment plan specified in this study.
Exclusion criteria
. Hyperprolactinemia: In the past year, patients with normal levels can be included.
. Menopausal FSH levels：FSH \> 15 mIU/mL. In the past year, patients with normal levels can be included.
. Patients with thyroid disease: TSH \< 0.2 mIU/mL or \>5.5 mIU/mL. In the past year, patients with normal levels can be included.
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.
What they're measuring
1
Ovulation rate
Timeframe: The 3-month treatment
Trial details
NCT IDNCT04120597
SponsorJiangxi University of Traditional Chinese Medicine