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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Liver ultrasound view (gradient change)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention group
curcumin capsules
干预措施: 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)
control group
receiving placebo
干预措施: 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)
结局指标
主要结局
Liver ultrasound view (gradient change)
时间窗: Before the intervention and 48 hours after the end of the intervention
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.
Body mass index (BMI)
时间窗: Before the intervention and 48 hours after the end of the intervention
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.
The level of low-density lipoprotein (LDL)
时间窗: before the intervention and 48 hours after the intervention
laboratory test
The level of high-density lipoprotein (HDL)
时间窗: before the intervention and 48 hours after the intervention
laboratory test
The level of triglyceride (TG)
时间窗: before the intervention and 48 hours after the intervention
laboratory test
The level of cholesterol
时间窗: before the intervention and 48 hours after the intervention
laboratory test
The level of alanine aminotransferase (ALT)
时间窗: before the intervention and 48 hours after the intervention
laboratory test
The level aspartate aminotransferase (AST)
时间窗: Before the intervention and 48 hours after the intervention
laboratory test
The level of alkaline phosphatase (ALP)
时间窗: Before the intervention and 48 hours after the intervention
laboratory test
次要结局
- The level of anxiety(Before the intervention and after the intervention)
研究者
Fateme Moshirenia
Associate Professor of Reproductive Health and Principal Investigator
Tarbiat Modarres University