A Randomized, Active Controlled, Multicentre, Prospective, Clinical Study to Compare the Efficacy and Safety of Dabur Hepano Tablet with a Marketed Liver Formulation in Liver Disorder Patients with Abnormal Liver Function Test (LFT)
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Percentage change in the Liver enzyme level from baseline to end of therapy compared between Hepano Tab and marketed liver formulation
研究概览
简要总结
The study will be a multicentre, randomized, double blinded, parallel-group, comparator study which is intended to evaluate the safety and efficacy of Hepano Tab in liver disorder subjects. Subjects with liver disorders of different etiologies in the age group of 18-65 years will be included in the study. Subjects will be randomized to either of the two treatment groups in 1:1 ratio. One group will receive Hepano Tablet and other will receive marketed product. Each group to get two tablets, twice a day for a period of 8 weeks. These subjects will be followed further for another 4 weeks after treatment period. The total duration of the study after randomization will be 12 weeks. Total completers for the study is planned to be 150 patients. The following parameters will be evaluated like Physical examination, Vital signs, Assessment of clinical improvement, Liver function test, Adverse Event (AE) assessments etc at various intervals of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Willing to provide informed consent to participate in the study • Males or females 18-65 years of age.
- •â€¢ Diagnosis of hepatic disorder with abnormal LFT and clinical icterus • Serum total bilirubin level more than equal to 2 mg/dL, AST or ALT >2 times ULN • The subject is able and willing to undertake all study-required procedures and has the ability to take oral medications.
排除标准
- •â€¢ Pregnant or lactating mother • Suspected hypersensitivity to contents of investigational product liver formulation • Known case of hepatitis-B or hepatitis-C • Obstructive Jaundice and Advanced liver diseases • Subjects with serious illness, • Current use of other herbal medicines for liver disorders or recent use within past two weeks • Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol.
结局指标
主要结局
Percentage change in the Liver enzyme level from baseline to end of therapy compared between Hepano Tab and marketed liver formulation
时间窗: From baseline to end of therapy
次要结局
- Percentage change in the serum total bilirubin level, liver enzyme and subjective clinical improvement from baseline to subsequent visits and end of therapy(From baseline to subsequent visits (Day 7, 14, 28) and end of therapy)