Dihydroartemisinin for the treatment of polycystic ovary syndrome: study protocol for a multi-centre placebo-controlled randomised clinical trial.
Liangshan Mu, Yanting Shen, Guiquan Wang...
https://pubmed.ncbi.nlm.nih.gov/42320967/Actively Recruiting
Led by Shanghai Zhongshan Hospital · Updated on 2025-04-20
150
Participants Needed
4
Research Sites
13 weeks
Total Duration
Polycystic ovary syndrome PCOS is a common hormone disorder affecting women of reproductive age, characterized by irregular menstrual cycles, excess male hormones, and ovaries with multiple cysts. Researchers are studying the effects of dihydroartemisinin, a drug that has shown promise in improving hormone levels and menstrual regularity in earlier studies, to see if it can help women with PCOS in a controlled clinical trial. The trial aims to evaluate whether this treatment can restore regular menstrual cycles over six months, along with improvements in ovarian follicles and metabolism. Participants will receive either dihydroartemisinin tablets at a dose of 40 mg three times daily or a matching placebo for 90 days. This is a randomized, placebo-controlled study with two groups, and both participants and study staff will not know who receives the active drug or placebo during the trial. Treatment effects will be monitored over a 26-week follow-up period after the start of treatment to assess menstrual cycle regularity and other hormonal and metabolic outcomes. Women in the study will undergo evaluations including hormone blood tests, ultrasound scans to count ovarian follicles, and assessments of metabolic markers before and immediately after treatment. Researchers will track the return of regular menstrual cycles during the six months following treatment start. Safety and adherence will be monitored throughout the trial period. Total participation will last about six months, including treatment and follow-up visits.
CONDITIONS
Dihydroartemisinin for the Treatment of Polycystic Ovary Syndrome
L
Liangshan Mu, MD, PhD
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Shanghai Zhongshan Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 90 days
Participants take Dihydroartemisinin tablets or placebo three times daily for 90 days.
Visits before and immediately after treatment
Duration - Up to 26 weeks after treatment
Participants are monitored to assess the occurrence of a regular menstrual cycle and other outcomes after treatment.
Periodic visits during follow-up
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Liangshan Mu, Yanting Shen, Guiquan Wang...
https://pubmed.ncbi.nlm.nih.gov/42320967/Shanghai Zhongshan Hospital
Lead Sponsor