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

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Composite Interceptive Med Science; Organic India

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.