Antiviral efficacy of Unani herbal medicine in chronic hepatitis B
Phase 2
Completed
- Conditions
- Health Condition 1: null- Chronic hepatitis BHealth Condition 2: B181- Chronic viral hepatitis B withoutdelta-agent
- Registration Number
- CTRI/2017/11/010386
- Lead Sponsor
- Shabnam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1.Clinically stable patients.
2.Patients of both sexes.
3.Patients in age groups of 18 to 60 years.
4.HbsAg +ve cases with a clinical history of more than 6 month.
5.Patients with HBV DNA Quantitative greater than 2,000 IU/mL.
6.ALT (alanine aminotransferase) >2 times of upper limit of normal.
7.Both HBeAg positive and negative patients.
Exclusion Criteria
1.Children below 18 years.
2.Patient above 60 years.
3.Pregnant and lactating mothers.
4.Mentally retarded person.
5.Patients who fail to give consent.
6.Patient with cirrhosis, portal hypertension/ascites, and obstructive jaundice.
7.Patients with diabetes, and hypertension.
8.Patients with kidney and heart disease.
9.Patients with neurological disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. HBsAg loss/ negativation <br/ ><br>2. HBeAg loss / negativation <br/ ><br>3. In HBV DNA, Complete virologic response: a plasma HBV DNA level of less than 103 copies/mL (200 IU/mL) with normalization of ALT at week 12 (after treatment). <br/ ><br>4. Biochemical response: Significant proportion of patients recover to normal ALT levels at 6th weeks and after 12 weeks. <br/ ><br>Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method 1. Partial virologic response: Significant mean reduction in HBV DNA of more than 1 log10 copies/ mL <br/ ><br>2. Significant mean change in the values of liver function tests (LFT). <br/ ><br>3. Significant improvement in quality of life. <br/ ><br>4. To provide tolerable and economic treatment. <br/ ><br>Timepoint: 12 weeks