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

Composite Interceptive Med Science

Status: Unknown

Conditions: Chronic Hepatitis B

Treatments: Drug: Polyherbal; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02899130

OI- 002- 2016

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Polyherbal

Experimental group

Description:

Combination of 3 whole herbs in a capsule

Treatment:

Drug: Polyherbal

Matching placebo

Placebo Comparator group

Description:

Similar looking inert capsules

Treatment:

Drug: Placebo