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A Clinical Trial to study the efficacy & safety of Colebrookea Oppositifolia (Aceteoside) in acute hepatitis patients.

Phase 2
Registration Number
CTRI/2008/091/000090
Lead Sponsor
Council of Scientific & Industrial Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

1.Individuals between 18-60 years of age of either sex suffering from acute hepatitis A/B. Diagnosis will be made on the basis of clinical history or immunological markers.

2.Patients ready to abide by trial procedures and to give informed consent.

Exclusion Criteria

1.Patients over 60 years or less than 16 years of age.

2.Pregnant or lactating mothers / complicated with Non A & B Hepatitis or Drug / alcoholic hepatitis / chronic active hepatitis.

3.Suspicion of auto â?? immune disease concomitant presence of disease of Cardiovascular System, renal or haemopoietic System or mental disease.

4.Patients using drugs which are likely to affect liver function tests e.g. NSAIDâ??s, Anticonvulsants, anti-diabeitic, statins , hormones, erythromycin etc.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome measures will be improvement in liver function tests, immunological test and liver ultrasound imaging as compared to base line using appropriate statistical test.Timepoint: 6 weeks onwards
Secondary Outcome Measures
NameTimeMethod
ot ApplicableTimepoint: Not Applicable
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