NCT07278128

Evaluation of the Therapeutic Effects of Curcumin on Changes in Lipid, Metabolic, and Hormonal Profiles, Liver Enzyme Activity, and Ultrasonography Morphology of the Liver in Women With Polycystic Ovary Syndrome and Nonalcoholic Fatty Liver Disease: A Double-blind, Placebo-controlled Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Fateme Moshirenia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Background and Objectives: Polycystic ovary syndrome (PCOS) and nonalcoholic fatty liver disease (NAFLD) commonly co-occur and are associated with insulin resistance, chronic inflammation, and metabolic and hormonal imbalances. Standard drug therapies can cause side effects, so safer and more effective alternatives are needed. This study evaluated whether daily curcumin supplementation could improve lipid, metabolic, hormonal, and liver-related parameters in women of reproductive age with both PCOS and NAFLD. Study Design and Participants: This was a double-blind, randomized, placebo-controlled clinical trial conducted at Arash General Women's Hospital. Ninety-four women of reproductive age diagnosed with PCOS and NAFLD were enrolled and randomly assigned to receive curcumin or placebo. Intervention: Participants in the intervention group received 1000 mg curcumin daily; the control group received 1000 mg placebo daily. The treatment period was 12 weeks. Measurements were taken at baseline and after 12 weeks. Key measurements: Anthropometric measurements, lipid profile (total cholesterol, LDL, HDL, triglycerides), fasting blood glucose, HbA1c, serum testosterone, anti-mullerian hormone (AMH), liver enzymes (AST, ALT, ALP), and liver ultrasound for degree of steatosis.

Conditions

• Polycystic Ovary Syndrome (PCOS) With Concurrent Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

Type	Name	Description
DRUG	Patients (women of reproductive age suffering from non-alcoholic fatty liver with polycystic ovary syndrome) receiving 500 mg curcumin capsules (prepared from the extraction of turmeric in the laborat	Patients (women of reproductive age suffering from non-alcoholic fatty liver with polycystic ovary syndrome) receiving 500 mg curcumin capsules (prepared from the extraction of turmeric in the laboratory of Shahid Beheshti Faculty of Pharmacy in Tehran), twice a day (one gram per day) for three months

Timeline

• Start date: 2024-06-22
• Primary completion: 2025-07-14
• Completion: 2025-07-22
• First posted: 2025-12-11
• Last updated: 2025-12-11

Locations

1 site across 1 country: Iran