CTRI/2024/02/063162尚未招募2 期
A randomized single blind two arm clinical trial of polyherbal unani formulation in the treatment of alcoholic hepatitis in comparison of jigreena capsules
PG Dept of Moalijat1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月3日最近更新:
试验速览
- 阶段
- 2 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 reduce ALT (Alanine transaminase) to normal value 50 IU/dl
研究概览
简要总结
Alcoholic hepatitis became one of the serious concern for rising death rates globally.Alcohol is the world’s 3rd largest risk factor for disease burden results in 2.5 million death every year.In this research trail 20 pateint will be given treatment a polyherbal unani formulation 3gm per day for 90 days with every 2 weeks fallow up as control drug and 20 patients will be given jigreena capsules 1.5 gm for 90 days with 2 weeks fallow up and results be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.On going consumption of alcohol more than 40gm per day in female and more than 60gm per day in male.
- •2.Total serum bilirubin more than 1.2mg/dl 3.ALT more than 50 IU/dl.
排除标准
- •1.Pateint with Diabates and uncontrolled hypertension, uncontrolled drug addiction,latent tuberculosis.
- •2.patient with Auto immune disorders.
- •3.patient with active hepatitis-B and chronic hepatitis-C.
- •4.patient with increase creatinine level more than 2.5mg/dl.
结局指标
主要结局
To reduce ALT (Alanine transaminase) to normal value 50 IU/dl
时间窗: Serum ALT and serum bilirubin at every 15 days
To reduce total serum bilirubin to normal 1.2mg/dl
时间窗: Serum ALT and serum bilirubin at every 15 days
次要结局
- To reduce hepatomegaly in alcoholic hepatitis patients(30 days)
研究者
Dr Mohammed Junaid Ali
Govt Nizamia tibbi college and General Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Clinical Trial to evaluate the effectiveness of Siddha formulations in the management of Kalleeral Noi(Alcoholic Liver Disease) among Out Patients attending Ayothidoss Pandithar HospitalCTRI/2025/02/081092National Institute of Siddha30
尚未招募
3 期
An interventional Study on selective siddha medicines like seenthil chooranam, inji rasayanam, mandurathi kudineer in the management of kaleeral noi(Alcoholic Liver Disease stage I and stage II)CTRI/2025/02/079854National Institute of siddha30
暂停
4 期
Assessment of Oral Ademetionine in Indian Patients with Alcoholic Liver DiseaseCTRI/2024/09/074413Dr Ashish Kumar60
尚未招募
2 期
Management of Hepatitis with Indigenous drugsCTRI/2024/05/067339Dr Soumya Sucharita Sarangi40
已完成
2 期
A Study on Mandurathi Kudineer in the management of Kaleeral Noi (Non-Alcoholic Fatty Liver Disease).CTRI/2024/06/068735National Institute of Siddha20