Effect of Polyherbal Formulation in Chronic Inactive Carriers of Hepatitis B Virus

Study Overview
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Brief Summary
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This trial will study the effect of a polyherbal capsule in lowering the viral load of patients with chronic Hepatitis B infection and record the incidence of from Hepatitis B surface antigen elimination in 12 months

Detailed Description
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A placebo controlled randomised trial. 3 herbs that have proven effect on eliminating the virus and normalizing liver function will be given. Equally matched placebo (blinded) will be given randomly to patients. All parameters of hepatitis B infection will be compared between the randomized groups

Official Title
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Antiviral Effect of 3 Herbs in Chronic Inactive Carriers of Hepatitis B Virus. - A Randomized Placebo Controlled Clinical Trial

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Polyherbal
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged above 18 years of age, with inactive chronic hepatitis B (HB) or immune tolerant phase, with or without dyslipidaemia and having all of the following HBsAg +ve for >6 months and anti-HBs negative Alanine amino transferase ≤ 2 upper limit of normal HBeAg positive or negative irrespective of viral DNA load Not currently on antiviral therapy for Chronic hepatitis B Exclusion Criteria: Any one of the following Patients with decompensated liver disease of any etiology(characterized by elevated bilirubin, raised International normalized ratio, or a history of ascites, variceal hemorrhage,hepatic encephalopathy, Spontaneous bacterial peritonitis, hepatorenal syndrome or Hepatocellular carcinoma) Family history of hepatocellular carcinoma Patients with HIV and Hepatitis C virus co-morbidity Pregnant, attempting to conceive, or lactating women Patients with diabetes mellitus Recent history of acute coronary syndrome (<6months) or chronic coronary artery disease with poor left ventricular function (by physician / cardiology opinion) Patients with renal failure ( Creatinine clearance less than 60 ml/min) Active substance or alcohol abuse and concurrent use of corticosteroids or immunosuppressive agents. Presence of extra hepatic manifestations Previously treated with pegylated interferon within the last 2 years Positive fibroscan or ultrasound elastography showing evidence of fibrosis (F3 and above) Current or former employees of organic India Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyherbal<br>Combination of 3 whole herbs in a capsule | Drug: Polyherbal<br>* Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa<br>* Other names: Liver Kidney Care;|
| Placebo Comparator: Matching placebo<br>Similar looking inert capsules | Drug: Placebo<br>* Inactive compound that is similar looking as the intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with change in mean Hepatitis B Virus (HBV) DNA by at least 2log10 units from baseline at end of treatment for those with HBV DNA ≥ 1000 IU/ml. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with change in hepatitis B surface antigen titers from baseline for those with HBV DNA <1000 IU/ml |  | 12 months | 
| Number of patients with Incidence of seroconversion from Hepatitis B surface antigen to anti-Hepatitis B surface antibody |  | 12 months |