Effect of Polyherbal Formulation in Chronic Inactive Carriers of Hepatitis B Virus
NCT ID: NCT02899130
Last Updated: 2017-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2016-10-31
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Polyherbal
Combination of 3 whole herbs in a capsule
Polyherbal
Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa
Matching placebo
Similar looking inert capsules
Placebo
Inactive compound that is similar looking as the intervention
Interventions
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Polyherbal
Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa
Placebo
Inactive compound that is similar looking as the intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. HBsAg +ve for \>6 months and anti-HBs negative
2. Alanine amino transferase ≤ 2 upper limit of normal
3. HBeAg positive or negative irrespective of viral DNA load
4. Not currently on antiviral therapy for Chronic hepatitis B
Exclusion Criteria
1. 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)
2. Family history of hepatocellular carcinoma
3. Patients with HIV and Hepatitis C virus 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.
18 Years
ALL
No
Sponsors
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Composite Interceptive Med Science
INDUSTRY
Responsible Party
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Principal Investigators
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Alben Sigamani, MD
Role: PRINCIPAL_INVESTIGATOR
Narayana Hrudayalaya Hospital
Locations
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Mazumdar Shaw Mutispeciality Hospital
Bangalore, Karnataka, India
Countries
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Central Contacts
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Other Identifiers
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OI- 002- 2016
Identifier Type: -
Identifier Source: org_study_id