The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Biochemical Markers and Imaging Studies of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in ALT (Alanin aminotransferase) level
研究概览
简要总结
The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease (NAFLD).
详细描述
In a randomized double-blind placebo-controlled clinical trial Shirazi's Thyme is compared with placebo. Investigators select randomly 90 patients with NAFLD by inclusion criteria. Investigators measure anthropometric and laboratory parameters including fasting blood sugar, insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90 days later. Patients are divided into two equal groups. Intervention group in addition to diet and exercise recommendations receive capsules containing 700 mg of Shirazi thyme powder daily for 90 days. Placebo group in addition to the same recommendations for diet and exercise, receives placebo capsules twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20-65 years
- •Body mass index: 18-35 kg/m2
- •Serum ALT level: >45 U/Lit. in Males, >29 U/Lit. in Females
- •Grade >=1 fatty liver in liver sonography
排除标准
- •Pregnancy and Lactation
- •Acute or chronic liver failure
- •Acute or chronic renal failure
- •Autoimmune or viral hepatitis
- •Wilson's disease
- •Diabetes mellitus
- •Alcoholism
- •Malignancy
- •Hypothyroidism or hyperthyroidism
- •Drug used in last three months: OCP, metformin, vitamin E, ursodeoxycholic acid, glucocorticoids, thiazolidenediones.
- •History of allergic reactions to Thyme
研究组 & 干预措施
Placebo
Wheat powder capsule 350 mg twice daily for 3 months
干预措施: Placebo (Other)
Thyme
Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months
干预措施: Thyme (Dietary Supplement)
结局指标
主要结局
Change in ALT (Alanin aminotransferase) level
时间窗: 3 months
Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System
时间窗: 3 months
次要结局
- Body weight(3 months)
- Waist circumference(3 months)
- Fasting blood sugar (FBS)(3 months)
- Fasting insulin level(3 months)
- Change in AST (Aspartate aminotransferase) level(3 months)
- Change in Gama GT (γ-glutamyl transpeptidase) level(3 monyhs)
- Hip circumference(3 months)
- Number of patients with adverse events(4 months)
研究者
Mesbah Shams, MD
Associate professor of Internal medicine and Endocrinology
Shiraz University of Medical Sciences