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

Phase 2

• Conditions: Acute Hepatitis A/B

• Registration Number: CTRI/2008/091/000090
• Lead Sponsor: Council of Scientific & Industrial Research

Brief Summary

This study is double blind placebo controlled, randomized clinical trial to evaluate the efficacy & safety of Colebrookea Oppostitifolia (Aceteoside) in acute hepatitis patients A/B. Acetoside is aqueous Extract obtained from the dried & powdered aerial parts of the Colebrookea Plant. Patients meeting inclusion criteria will be randomized & divided in two groups, one group will receive Acteoside 25 mg T.D. S and other group placebo 25 mg TDS for a period of Six weeks, the primary out come measure will be statistical improvement in liver function tests like S.Bil, S.Alt, S.Ast, S. Albumin S. Alkaline phosphate & prothrombin time these will be assessed at base line, 1 wk, 2 wks, 4 wks, & 6 wks.Immunological Tests-1 gm anti HBC anti body, S.HBeAG, and 1 gm Anti HAV anti body, HBsAg, Anti HBs antibody , S.HBeAg, ANTI Hbe Ab, 1 gm ANTI HAV antibody and liver ultrasound imaging. Adverse drug reaction (ADR) monitoring will be done throughout the study as per the pharmacovigilance programme.

Detailed Description

Not available

Recruitment & Eligibility

• 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 – 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. NSAID’s, Anticonvulsants, anti-diabeitic, statins , hormones, erythromycin etc.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	6 weeks onwards

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1)

LADY HARDINGE MEDICAL COLLEGE & ALLIED HOSPITALS; 🇮🇳 Delhi, DELHI, India

LADY HARDINGE MEDICAL COLLEGE & ALLIED HOSPITALS

🇮🇳Delhi, DELHI, India

DR. HARMEET SINGH REHAN

Principal investigator

09811694040

harmeetrehan@hotmail.com