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Trial record 17 of 351 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Organic India
Sponsor:
Information provided by (Responsible Party):
Organic India
ClinicalTrials.gov Identifier:
NCT02899130
First received: September 8, 2016
Last updated: October 14, 2016
Last verified: October 2016
  Purpose
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 Intervention
Chronic Hepatitis B
Drug: Polyherbal
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Organic India:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • Number of patients with Incidence of seroconversion from Hepatitis B surface antigen to anti-Hepatitis B surface antibody [ Time Frame: 12 months ]

Estimated Enrollment: 80
Study Start Date: October 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Organic India
ClinicalTrials.gov Identifier: NCT02899130     History of Changes
Other Study ID Numbers: OI- 002- 2016 
Study First Received: September 8, 2016
Last Updated: October 14, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

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

ClinicalTrials.gov processed this record on February 17, 2017