Effect of poly herbal formulation in chronic inactive carriers of hepatitis B virus

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Adults aged above 18 years of age, with inactive chronic hepatitis B or immune tolerant phase, with or without dyslipidaemia and having all of the following

1.HBsAg +ve for >6 months and anti-HBs negative

2.Alanine amino transferase <= 2 upper limit of normal(ULN)

3.HBeAg positive or negative irrespective of viral DNA load

4.Not currently on antiviral therapy for Chronic hepatitis B

Exclusion Criteria

Any one of the following

1.Patients with decompensated liver disease of any etiology(characterized by elevated bilirubin, raised INR, or a history of ascites, variceal hemorrhage,hepatic encephalopathy, Spontaneous bacterial peritonitis, hepatorenal syndrome or Hepatocellular carcinoma)

2.Family history of hepatocellular carcinoma

3.Patients with HIV and HCV co-morbidity

4.Pregnant, attempting to conceive, or lactating women

5.Patients with diabetes mellitus

6.Recent history of acute coronary syndrome ( <6months) or chronic coronary artery disease with poor left ventricular function (by physician / cardiology opinion)

7.Patients with renal failure ( Creatinine clearance less than 60 ml/min)

8.Active substance or alcohol abuse and concurrent use of corticosteroids or immunosuppressive agents.

9.Presence of extra hepatic manifestations

10.Previously treated with pegylated interferon within the last 2 years

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

12.Current or former employees of organic India

13.Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.

14.Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is a change from baseline in mean HBV DNA by at least 2log10 units at end of treatment â?? 12 months for those with HBV DNA â?¥ 1000 IU/ml.Timepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
umber of patients with incidence of seroconversion from Hepatitis B surface antigen to anti-hepatitis B antibody.Timepoint: 12 months;Number of patients with resurgence of HBeAg positivity.Timepoint: 12 months