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

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ClinicalTrials.gov Identifier: NCT02899130
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Organic India

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Polyherbal Drug: Placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antiviral Effect of 3 Herbs in Chronic Inactive Carriers of Hepatitis B Virus. - A Randomized Placebo Controlled Clinical Trial
Study Start Date : October 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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 Name: Liver Kidney Care

Placebo Comparator: Matching placebo
Similar looking inert capsules
Drug: Placebo
Inactive compound that is similar looking as the intervention




Primary Outcome Measures :
  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. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of patients with change in hepatitis B surface antigen titers from baseline for those with HBV DNA <1000 IU/ml [ Time Frame: 12 months ]
  2. Number of patients with Incidence of seroconversion from Hepatitis B surface antigen to anti-Hepatitis B surface antibody [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899130


Contacts
Contact: Alben Sigamani, MD +91 8884431444 alben.sigamani.dr@nhhospitals.org
Contact: Sanjaya Chauhan, Pharm.D +91 9611252350 ext 2388 drsanjayachauhan49@gmail.com

Locations
India
Mazumdar Shaw Mutispeciality Hospital Recruiting
Bangalore, Karnataka, India, 560099
Principal Investigator: Alben Sigamani, MD         
Sponsors and Collaborators
Organic India
Investigators
Principal Investigator: Alben Sigamani, MD Narayana Hrudayalaya Hospital

Responsible Party: Organic India
ClinicalTrials.gov Identifier: NCT02899130     History of Changes
Other Study ID Numbers: OI- 002- 2016
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections