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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyherbal | Experimental | Combination of 3 whole herbs in a capsule |
|
| Matching placebo | Placebo Comparator | Similar looking inert capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyherbal | Drug | Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa |
|
| 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 |
| 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 |
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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
Exclusion Criteria:
Any one of the following
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alben Sigamani, MD | Contact | +91 8884431444 | alben.sigamani.dr@nhhospitals.org | |
| Sanjaya Chauhan, Pharm.D | Contact | +91 9611252350 | 2388 | drsanjayachauhan49@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alben Sigamani, MD | Narayana Hrudayalaya Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mazumdar Shaw Mutispeciality Hospital | Recruiting | Bangalore | Karnataka | 560099 | India |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Placebo | Drug | Inactive compound that is similar looking as the intervention |
|
| 12 months |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |