Health Condition 1: R945- Abnormal results of liver functionstudies
Conditions
Interventions
Intervention1: Dabur Hepano Tablet: 2 tablets at a time, twice daily for 8 weeks
Control Intervention1: Marketed Ayurvedic formulation: 2 tablets at a time, twice daily for 8 weeks
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Vidyadhar Kumbhar
Dabur India Limited
Outcome results
None listed