Effectiveness Of Individualized Homoeopathic Medicines In The Treatment Of Non-alcoholic Fatty Liver Disease:A Prospective Single-arm Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serum ALT and serum AST level
研究概览
简要总结
A prospective single-arm study to know the effectiveness of individualized homoeopathic medicines in Non-alcoholic fatty liver disease
OBJECTIVES-
Primary Objective:
- To assess the effectiveness of individualized Homoeopathic medicines in the treatment of NAFLD by evaluating change in serum ALT and serum AST
Secondary objective
-
To find out the changes in grade level of NAFLD in ultrasonography after Homoeopathic medicines
-
To determine the changes in Quality of Life WHO Quality of Life Scale-Brief in patients with NAFLD after homoeopathic intervention.
-
To find out changes in BARD Score in patients with NAFLD to predict risk of advanced fibrosis
• DIAGNOSTIC CRITERIA
• Liver function test
• Ultra sonogram(USG)of abdomen
• Procurement of medicines: Pharmacy of Nehru Homoeopathic Medical College and Hospital. If not available it will be provide from a GMP certified pharmacy
• Study duration: maximum 12 months
• Study design: Prospective open label single-arm clinical study.
• Sample size- Minimum 30 cases
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Non-Alcoholic patients 2.Both male and female patients aged between 18-70 years.
- •3.Patients with elevated Serum ALT 4.Patients with elevated serum AST 5.Ultrasonographically diagnosed cases of NAFLD.
排除标准
- •1.Subjects with history of drug intake known to result in liver enzyme elevation 2.Patients with complications of like liver cirrhosis, hepatocellular carcinoma.
- •3.Patients with cholelithiasis & cholecystitis.
- •4 Pregnant and lactating women.
结局指标
主要结局
Serum ALT and serum AST level
时间窗: At baseline and at an interval of 3 months
次要结局
- Comparing changes in Ultrasonography of Abdomen
- Improvement in quality of life (WHO-QOL bref scale )(At baseline and at the end of study)
- BARD SCORE(3 months)
研究者
Dr Ancy Saj
Nehru Homoeopathic Medical College and Hospital