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

Antiviral Effect of 3 Herbs in Chronic Inactive Carriers of Hepatitis B Virus. - A Randomized Placebo Controlled Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: Placebo; Drug: Polyherbal

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Recruiting
      • Mazumdar Shaw Mutispeciality Hospital
      • Principal Investigator: Alben Sigamani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polyherbal; Combination of 3 whole herbs in a capsule	Drug: Polyherbal; Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa; Other Names: Liver Kidney Care
Placebo Comparator: Matching placebo; Similar looking inert capsules	Drug: Placebo; Inactive compound that is similar looking as the intervention

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Composite Interceptive Med Science
• Investigators: Principal Investigator: Alben Sigamani, MD, Narayana Hrudayalaya Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic
• Other Study ID Numbers: OI- 002- 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED