Antiviral effect of 3 herbs in chronic inactive carriers of hepatitis B virus- A randomized placebo controlled clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The primary outcome is a change from baseline in mean HBV DNA by at least 2log10 units at end of treatment – 12 months for those with HBV DNA ≥ 1000 IU/ml.
研究概览
简要总结
Nearly 37 million Indians are carriers of Hepatitis B virus. Current therapies have not been effective in clearing the virus completely. Herbal medications are commonly used in treating acute and chronic hepatitis B infections.
The aim of this trial is to study the effect of a poly herbal capsule containing 3 herbs: Bhumyamalaki (Phyllanthus niruri), Punarnava (Boerhaavia diffusa) and Katuki (Picrorhiza kurroa) in lowering viral load and increasing incidence of seroconversions in Hepatitis B surface antigen. Treatment will be given for 12 months and outcomes will be compared at end of treatment period.
We hypothesize that 30 – 40% more patients, will clear the surface antigen in the active arm compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged above 18 years of age, with inactive chronic hepatitis B 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(ULN) 3.HBeAg positive or negative irrespective of viral DNA load 4.Not currently on antiviral therapy for Chronic hepatitis B.
排除标准
- •Any one of the following 1.Patients with decompensated liver disease of any etiology(characterized by elevated bilirubin, raised INR, 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 HCV 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.
结局指标
主要结局
The primary outcome is a change from baseline in mean HBV DNA by at least 2log10 units at end of treatment – 12 months for those with HBV DNA ≥ 1000 IU/ml.
时间窗: 12 months
次要结局
- Number of patients with incidence of seroconversion from Hepatitis B surface antigen to anti-hepatitis B antibody.(12 months)
- Number of patients with resurgence of HBeAg positivity.(12 months)