COMPARATIVE EFFECTIVENESS OF SIDDHA TREATMENT REGIMEN ANDKADUKKAI TEA (HERBAL BEVERAGE) IN MAJAL KAAMALAI(CHRONIC HEPATITIS-B)

Phase 2

Conditions: Health Condition 1: B181- Chronic viral hepatitis B withoutdelta-agent

Registration Number: CTRI/2023/09/057785

Lead Sponsor: OT APPLICABLE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Adults aged above 18 years of age, with inactive chronic hepatitis B (HB) or immune tolerant phase, with or without liver enzyme changes and having all of the following

1.HBsAg +ve for >6 months

2.Patientswhoarepositive forHBVwith increasedviral loadabove300 IU/mL

3.Not currently on antiviral therapy for Chronic hepatitis B or discontinued antiviral treatment for the last 3 months

Exclusion Criteria

? Pregnant, lactatingwomen and Children

? Evidence of any other chronic liver disease

? Patient with hepatocellular carcinoma

? Coinfection with HIV,HCV

? Active substance or alcohol abuse and concurrent use of corticosteroids/NSAIDS or immunosuppressive agents

? Positive fibroscan or ultrasound elastography showing evidence of fibrosis (F3 and above)

? Allergic to the drug ingredients

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary out come: <br/ ><br>?Primary Outcome is mainly assessed by reduction in HBV viral load (Quantitative PCR) <br/ ><br>Timepoint: one year

Secondary Outcome Measures

Name	Time	Method
?To evaluate the safety of the study drugs by assessing adverse events & laboratory investigations (viz., hemogram, liver function tests (LFT), renal function tests (RFT), lipid profile).Timepoint: one year