Investigating effect of Triphala in patients suffering from Non-alcoholic fatty liver disease (NAFLD): a proof of concept clinical study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Expected outcomes:
研究概览
简要总结
Objectives:To determine the effect of Triphala on fatty liver changes
To evaluate the effect of Triphala on insulin resistance
To assess the effect of Triphala on weight and waist circumferences
Methodology: This is a randomised, single arm clinical study.
Study Groups:
There will be a single group of individuals receiving tablets made from Triphala aqueous extract (n=6).
Dosage:
Triphala tablets (each weighing 500 mg) will be administered in the dose of 3 tablets twice a day post meals with water.
Duration of treatment: 3 months
Evaluation Parameters: waist circumference and body composition analysis, fasting glucose, fasting insulin, glycosylated hemoglobin, lipid profile, complete blood count, liver function tests (AST, ALT), platelet count and kidney function (Creatinine, Blood Urea Nitrogen)
Time Points : Day 0, Day 30, Day 60, Day 90
Expected Outcome: Triphala tablets will prove beneficial in NAFLD
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Individuals of either sex between the age group of
- •60 years 2.Individuals with BMI ≥ 27.5 kg/m2- ≤ 35 kg/m2 3.Individuals with presence of NAFLD grade II or above on Ultrasound 4.Individuals willing to abide by the study related procedures.
排除标准
- •1.Individuals with secondary obesity e.g. Prader-Willi syndrome, Corticosteroid induced obesity, or other endocrine disorders 2.Individuals with alcohol addiction 3.Individuals with viral hepatitis disorders (Hepatitis B, Hepatitis C) 4.Individuals with known history of usage of herbal medications/ nutritional supplements/ multivitamin supplements/ pre and probiotic supplementation within past 30 days for any indication 5.Pregnant or lactating females.
结局指标
主要结局
Expected outcomes:
时间窗: Day 0 & Day 90
Lipid profile, Complete blood count, Liver profile, Renal Profile, Fasting Insulin, Fasting blood glucose
时间窗: Day 0 & Day 90
Assessment Parameters:
时间窗: Day 0 & Day 90
Fatty liver changes by FibroScan
时间窗: Day 0 & Day 90
Body weight, BMI and waist circumferences
时间窗: Day 0 & Day 90
1.10% improvement in fatty liver changes due to Triphala
时间窗: Day 0 & Day 90
2.10% improvement in insulin resistance due to Triphala
时间窗: Day 0 & Day 90
次要结局
- 10% improvement in the anthropometry due to Triphala(Day 0, Day 30,Day 60 & Day 90)