An open label Clinical trial to evaluate the efficacy of Muliv Strong Syrup in the management of Non- Alcoholic Fatty Liver disease (NAFLD).
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in NAFLD Score
研究概览
简要总结
It is an open labeled single armed, single centric, prospective interventional clinical study to evaluate the efficacy of Muliv Strong Syrup on 50 patients suffering Non- Alcoholic Fatty Liver disease (NAFLD). The study will be conducted in National Institute of Ayurveda, Jaipur, Rajasthan,
Dose: 10 ml tds Muliv Strong Syrup orally will be given before meal with luke warm water for 45days.
Purpose –
To evaluate the effect of Muliv Strong Syrup in the management of Non- Alcoholic Steatohepatitis (NASH).
Research question: Is Muliv Strong Syrup is effective in management of Non- Alcoholic Fatty Liver disease (NAFLD).
Null Hypothesis: Muliv Strong Syrup is not effective in the management of Non- Alcoholic Fatty Liver disease (NAFLD).
Alternative hypothesis: Muliv Strong Syrup is effective in the management of Non- Alcoholic Fatty Liver disease (NAFLD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex not taking any medicine will be included in the study.
- •Individuals suffering from NAFLD with or without elevated liver enzymes or hepatomegaly will be included.
- •Patients willing to give informed consent for the study.
排除标准
- •Individuals with chronic hepatitis (more than 3 months), Patients with malignant jaundice, patient with acute hepatitis (Other than infective).
- •Individuals with known hypersensitivity to ingredients of study products; individuals with immediate life threatening diseases such as preexisting cardiovascular, liver, or neoplastic diseases or who received any immunosuppressant, sedative, hypnotic or tranquilizer within 14 days prior to enrollment;
- •Individuals with any psychiatric illness which may impair the ability to provide written ICF.
- •Individuals participating in any other clinical trial.
- •Pregnant or lactating females.
- •Alcohol, smoke, and drug abusers will be excluded from study.
结局指标
主要结局
Changes in NAFLD Score
时间窗: 60 days
次要结局
- Changes in Subjective parameters, LFT, USG(60days)