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

A double blind, placebo controlled comparative, randomized study to evaluate efficacy & Safety of Colebrookea Oppositifolia (Aceteoside) in acute hepatitis A/B Patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000090

Enrollment

200

Registered

2008-06-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tablet 25 Mg. 25 Mg with water soluble fraction of Colebrookea oppositifolia extract: Tablet 25 mg TDS for 6 weeks Control Intervention1: Tablet 25 Mg Placebo: Tablet 25 mg TDS for 6 we

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactDR. K. A. Suri

PROFESSOR & HEAD DEPT OF PHARMACOLOGY, LADY HARDINGE MEDICAL COLLEGE & SMT S.K. HOSPITAL, NEW DELHI â?? 110001

harmeetrehan@hotmail.com09811694040

Outcome results