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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

NCT07278128 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-12-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Fateme Moshirenia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-22
Primary Completion
2025-07-14
Completion
2025-07-22

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278128 on ClinicalTrials.gov