Clinical Study of Dabur Hepano tablet in comparison with a marketed Hepatoprotective formulation in Liver Disorder Patients
- Conditions
- Health Condition 1: R945- Abnormal results of liver functionstudies
- Registration Number
- CTRI/2014/02/004410
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
• Willing to provide informed consent to participate in the study
• Males or females 18-65 years of age.
• 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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in the Liver enzyme level from baseline to end of therapy compared between Hepano Tab and marketed liver formulationTimepoint: From baseline to end of therapy
- Secondary Outcome Measures
Name Time Method Percentage change in the serum total bilirubin level, liver enzyme and subjective clinical improvement from baseline to subsequent visits and end of therapyTimepoint: From baseline to subsequent visits (Day 7, 14, 28) and end of therapy