Clinical trial NCT02899130: Effect of Polyherbal Formulation in Chronic Inactive Carriers of Hepatitis B Virus
Official title: Antiviral Effect of 3 Herbs in Chronic Inactive Carriers of Hepatitis B Virus. - A Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis B
Lead sponsor: Composite Interceptive Med Science
Sponsor class: INDUSTRY
First posted: 2016-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients with change in hepatitis B surface antigen titers from baseline for those with HBV DNA <1000 IU/ml
timeFrame: 12 months
measure: Number of patients with Incidence of seroconversion from Hepatitis B surface antigen to anti-Hepatitis B surface antibody
timeFrame: 12 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Mazumdar Shaw Mutispeciality Hospital
state: Karnataka
Study officials:
affiliation: Narayana Hrudayalaya Hospital
name: Alben Sigamani, MD
role: PRINCIPAL_INVESTIGATOR
References: