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
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Locations near you
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Full eligibility criteria for NCT02899130
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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.
All locations for NCT02899130
Mazumdar Shaw Mutispeciality Hospital
Bangalore, Karnataka, India, 560099
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View full eligibility
Tris trial is registered with FDA with number: NCT02899130. The sponsor of the trial is Organic India and it is looking for 80 volunteers for the current phase.
Official trial title: Antiviral Effect of 3 Herbs in Chronic Inactive Carriers of Hepatitis B Virus. - A Randomized Placebo Controlled Clinical Trial
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