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 | Completed Phase 2 DMC

• 1 other identifier: TarbiatModaresU
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• The level of anxiety

  Before the intervention and after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

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 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

Intervention group; control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fateme Moshirenia: lead

Study Sites (1)

Tarbiat Modares university

Tehran, Tehran Province, 1411713116, Iran

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Reproductive Health and Principal Investigator

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: December 11, 2025
• Study Start: June 22, 2024
• Primary Completion: July 14, 2025
• Study Completion: July 22, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-11

Locations

IR (1)