Health Condition 1: null- Inactive chronic hepatitis B or immune tolerant phase of chronic hepatitis B
Conditions
Interventions
Intervention1: Polyherbal Capsule: Each capsule contains 3 herbs: Phyllanthus niruri, Boerhaavia diffusa, Picrorhiza kurora. All the participants will be instructed to take 3 capsules twice daily at a
Sponsors
Organic India
Eligibility
Inclusion criteria
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 3.HBeAg positive or negative irrespective of viral DNA load 4.Not currently on antiviral therapy for Chronic hepatitis B
Exclusion criteria
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 ( 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number 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 | — |
Countries
India
Contacts
Public ContactDr Sindhu N
Organic India
Outcome results
None listed