Chronic Hepatitis B
Conditions
Brief summary
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
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
Interventions
DRUGPolyherbal
Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa
DRUGPlacebo
Inactive compound that is similar looking as the intervention
Sponsors
Composite Interceptive Med Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
* Any one of the following 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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
India
Contacts
Primary ContactAlben Sigamani, MD
Backup ContactSanjaya Chauhan, Pharm.D
Outcome results
None listed