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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome (PCOS) With Concurrent Nonalcoholic Fatty Liver Disease (NAFLD)
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran
  • Tehran Province
    • Tehran, Tehran Province, Iran, 1411713116
      • Tarbiat Modares university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; curcumin capsules	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
Placebo Comparator: control group; receiving placebo	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver ultrasound view (gradient change)	There is no need to fast, and as soon as possible, the patient is referred to an ultrasound specialist for diagnostic and examination procedures according to specific criteria for examining fatty liver.	Before the intervention and 48 hours after the end of the intervention
Body mass index (BMI)	Measuring height with a centimeter tape and measuring weight with a digital scale and then entering the obtained values into the formula of weight in kilograms divided by the square of height in meters to calculate the body mass index.	Before the intervention and 48 hours after the end of the intervention
The level of low-density lipoprotein (LDL)	laboratory test	before the intervention and 48 hours after the intervention
The level of high-density lipoprotein (HDL)	laboratory test	before the intervention and 48 hours after the intervention
The level of triglyceride (TG)	laboratory test	before the intervention and 48 hours after the intervention
The level of cholesterol	laboratory test	before the intervention and 48 hours after the intervention
The level of alanine aminotransferase (ALT)	laboratory test	before the intervention and 48 hours after the intervention
The level aspartate aminotransferase (AST)	laboratory test	Before the intervention and 48 hours after the intervention
The level of alkaline phosphatase (ALP)	laboratory test	Before the intervention and 48 hours after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of anxiety	With the history of taking and filling the DASS questionnaire	Before the intervention and after the intervention

Collaborators and Investigators

• Sponsor: Fateme Moshirenia

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2024
• Primary Completion (Actual): July 14, 2025
• Study Completion (Actual): July 22, 2025

Study Registration Dates

• First Submitted: November 29, 2025
• First Submitted That Met QC Criteria: November 29, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 29, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome; Organic Chemicals; Hydrocarbons, Acyclic; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Diarylheptanoids; Heptanes; Alkanes; Catechols; Phenols; Benzene Derivatives; Curcumin
• Other Study ID Numbers: TarbiatModaresU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No