Efficacy of Individualized Homeopathic medicines in Non Alcoholic Fatty Liver Disease A Randomized Placebo Controlled Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine the efficacy of individualized homoeopathic medicines relative to a placebo in
研究概览
简要总结
This study is for the clinical evaluation of individualized homoeopathic medicine in the treatment of non alcoholic fatty liver diseases. study conducted in two groups. One group will be provided with homoeopathic medicine and other will be provided with identical placebo. Each case will be reviewed at 3 weeks for a period of minimum 15 weeks. Serum ALT and ALT estimation will be done at an interval of 3 weeks. Risk for fibrosis will be assessed by FIB4 index. USG abdomen will be done at baseline and at final outcome of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Cases with elevated liver enzymes ALT or AST.
- •Ultrasonography abdomen findings with grade 1& grade 2 fatty liver.
- •3.Non Alcoholic Male and Female Patients aged between 18-60years.
- •Individuals with present or past history of alcohol consumption in an amount less than a particular level aged between 18-60 years(20 gm/day for males and 10 gm/day for females) of alcohol will be included.
排除标准
- •Adults who had a heart attack or stroke, or other atherosclerotic disease.
- •Patients diagnosed with diabetics (glycosylated hemoglobin above 6.5%.)
- •Patients diagnosed with moderate and severe hypertension (BP 160/100 mmHg above)
- •Patients with HBsAg positive.
- •Patients with complications of hepatic steatosis like liver cirrhosis, hepatocellular carcinoma.
- •Pregnant and lactating women.
结局指标
主要结局
To determine the efficacy of individualized homoeopathic medicines relative to a placebo in
时间窗: Each case will be reviewed at 3 weeks interval and followed for a period of minimum 15 weeks. | Serum ALT and AST value estimation will be done at an interval of 3 weeks or whenever | necessary. | Risk for fibrosis will be assessed by calculating fibrosis score FIB-4 index. | USG Abdomen will be done at baseline and at final outcome period.
modifying blood ALT and AST levels and grading of fatty liver in ultrasonography findings in
时间窗: Each case will be reviewed at 3 weeks interval and followed for a period of minimum 15 weeks. | Serum ALT and AST value estimation will be done at an interval of 3 weeks or whenever | necessary. | Risk for fibrosis will be assessed by calculating fibrosis score FIB-4 index. | USG Abdomen will be done at baseline and at final outcome period.
patients with NAFLDs after 15 weeks of study.
时间窗: Each case will be reviewed at 3 weeks interval and followed for a period of minimum 15 weeks. | Serum ALT and AST value estimation will be done at an interval of 3 weeks or whenever | necessary. | Risk for fibrosis will be assessed by calculating fibrosis score FIB-4 index. | USG Abdomen will be done at baseline and at final outcome period.
次要结局
- determine the change in ‘risk for fibrosis’ in patients before and after treatment by FIB-4(index.)
研究者
Dr Labeeba Ali K
Government Homoeopathic Medical College, Karaparamba Kozhikode