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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02899130
• Other study ID #: OI- 002- 2016
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2016
• Last updated: December 5, 2017
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: December 2017
• Source: Organic India
• Contact: Alben Sigamani, MD
• Phone: +91 8884431444
• Email: alben.sigamani.dr[@]nhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Polyherbal
Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa
• Placebo
Inactive compound that is similar looking as the intervention

Locations

Country	Name	City	State
India	Mazumdar Shaw Mutispeciality Hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Organic India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with change in hepatitis B surface antigen titers from baseline for those with HBV DNA <1000 IU/ml		12 months
Secondary	Number of patients with Incidence of seroconversion from Hepatitis B surface antigen to anti-Hepatitis B surface antibody		12 months