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

NCT ID: NCT07278128

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-22
• Study Completion Date: 2025-07-22

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

curcumin capsules

Group Type: EXPERIMENTAL

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

Intervention Type: 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 laboratory of Shahid Beheshti Faculty of Pharmacy in Tehran), twice a day (one gram per day) for three months

control group

receiving placebo

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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 laboratory of Shahid Beheshti Faculty of Pharmacy in Tehran), twice a day (one gram per day) for three months

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Women of reproductive age from 18 to 45 years old Women with polycystic ovary syndrome and non-alcoholic fatty liver disease Having two of the three Rotterdam criteria including: Having an ultrasound appearance of polycystic ovaries, having serum hyperandrogenism with/without clinical symptoms related to hyperandrogenism such as acne, hirsutism, acanthosis nigricans, etc., having an ovulation disorder and irregular menstrual cycle. Ability to speak and write in Persian

Exclusion Criteria

-Pregnancy Breastfeeding Using hormonal methods for contraception Having any other diagnosed disease Sensitivity to turmeric History of advanced chronic liver disease Smoking and alcohol use Drug addiction Adrenal hyperplasia that has symptoms similar to polycystic ovary syndrome Kidney failure or any active digestive disorder Other chronic non-metabolic diseases Thyroid disease Hyperprolactinemia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fateme Moshirenia

OTHER

Sponsor Role: lead

Responsible Party

Fateme Moshirenia

Associate Professor of Reproductive Health and Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tarbiat Modares university

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

TarbiatModaresU

Identifier Type: -

Identifier Source: org_study_id