NCT02899130

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 6, 2017

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

September 8, 2016

Last Update Submit

December 5, 2017

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Polyherbal

EXPERIMENTAL

Combination of 3 whole herbs in a capsule

Drug: Polyherbal

Matching placebo

PLACEBO COMPARATOR

Similar looking inert capsules

Drug: Placebo

Interventions

PolyherbalDRUG

Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa

Also known as: Liver Kidney Care
Polyherbal
PlaceboDRUG

Inactive compound that is similar looking as the intervention

Matching placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • HBsAg +ve for \>6 months and anti-HBs negative
  • Alanine amino transferase ≤ 2 upper limit of normal
  • HBeAg positive or negative irrespective of viral DNA load
  • Not currently on antiviral therapy for Chronic hepatitis B

You may not qualify if:

  • Any one of the following
  • 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)
  • Family history of hepatocellular carcinoma
  • Patients with HIV and Hepatitis C virus co-morbidity
  • Pregnant, attempting to conceive, or lactating women
  • Patients with diabetes mellitus
  • Recent history of acute coronary syndrome (\<6months) or chronic coronary artery disease with poor left ventricular function (by physician / cardiology opinion)
  • Patients with renal failure ( Creatinine clearance less than 60 ml/min)
  • Active substance or alcohol abuse and concurrent use of corticosteroids or immunosuppressive agents.
  • Presence of extra hepatic manifestations
  • Previously treated with pegylated interferon within the last 2 years
  • Positive fibroscan or ultrasound elastography showing evidence of fibrosis (F3 and above)
  • Current or former employees of organic India
  • Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
  • Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mazumdar Shaw Mutispeciality Hospital

Bangalore, Karnataka, 560099, India

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alben Sigamani, MD

    Narayana Hrudayalaya Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alben Sigamani, MD

CONTACT

+91 8884431444alben.sigamani.dr@nhhospitals.org

Sanjaya Chauhan, Pharm.D

CONTACT

+91 9611252350drsanjayachauhan49@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 14, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

December 6, 2017

Record last verified: 2017-12

Locations

IN(1)