Comparative Study on The Effect of Individualised Homoeopathic Medicine Versus Placebo in Treatment of Non-Alcoholic Fatty Liver Disease: An Interventional Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Fib-4 scorring and measuring serum alanine aminotransferase (ALT)
研究概览
简要总结
This is a double-arm interventional trial that will examine the effectiveness of individualised homoeopathic medicine in comparison to placebo as an intervention to treat Non-Alcoholic Fatty Liver Disease (NAFLD) in adults. The sample size that will be used will comprise 54 participants who meet the inclusion criteria that will be divided into two groups (Group A) which will receive individualized homoeopathic medicine with concomitant care (yoga and proper diet ) and Group B which will receive placebo with the same concomitant care. The research process will take one year and six months and monthly follow-ups of each patients or as per requirements, upto six months. The main outcomes involve the evaluation of hepatic changes of fatty in the liver through Fib-4 score and serum ALT; secondary outcome is the ultrasonographic assessment of the status of hepatomegaly after six months. The research aims to establish whether individualised homoeopathic treatment can provide any substantial result as compared to the placebo in the management of NAFLD as a part of the evidence-based validation of homoeopathic treatment.
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
- •Patients attending OPD’s and IPD of MBHMCH, diagnosed with non-alcoholic fatty liver disease with hepatomegaly grade 1 or grade 2, by ultrasonography done within last three months from the day of first visit.
- •2.Patient willing to give informed consent.
排除标准
- •1.Patient Having Grade 3 Fatty Liver.
- •Patient having Cirrhotic Changes.
- •Terminally Ill Patient.
- •Patients with Any Kind of Substance Abuse.
- •Patient Diagnosed with Psychological Illness.
结局指标
主要结局
Fib-4 scorring and measuring serum alanine aminotransferase (ALT)
时间窗: At every two months after, three times
次要结局
- Ultrasonography of whole abdomen(At baseline or under three months before enrollment and after 6 months.)
研究者
Dr Kausthab Dey
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital