NCT02899130Unknown不适用
Antiviral Effect of 3 Herbs in Chronic Inactive Carriers of Hepatitis B Virus. - A Randomized Placebo Controlled Clinical Trial
Composite Interceptive Med Science1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •HBsAg +ve for >6 months and anti-HBs negative
- •Alanine amino transferase ≤ 2 upper limit of normal
- •HBeAg positive or negative irrespective of viral DNA load
- •Not currently on antiviral therapy for Chronic hepatitis B
排除标准
- •Any one of the following
- •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)
- •Family history of hepatocellular carcinoma
- •Patients with HIV and Hepatitis C virus co-morbidity
- •Pregnant, attempting to conceive, or lactating women
- •Patients with diabetes mellitus
- •Recent history of acute coronary syndrome (<6months) or chronic coronary artery disease with poor left ventricular function (by physician / cardiology opinion)
- •Patients with renal failure ( Creatinine clearance less than 60 ml/min)
- •Active substance or alcohol abuse and concurrent use of corticosteroids or immunosuppressive agents.
- •Presence of extra hepatic manifestations
- •Previously treated with pegylated interferon within the last 2 years
- •Positive fibroscan or ultrasound elastography showing evidence of fibrosis (F3 and above)
- •Current or former employees of organic India
- •Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
- •Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
研究组 & 干预措施
Polyherbal
Experimental
Combination of 3 whole herbs in a capsule
干预措施: Polyherbal (Drug)
Matching placebo
Placebo Comparator
Similar looking inert capsules
干预措施: Placebo (Drug)
结局指标
主要结局
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.
时间窗: 12 months
次要结局
- Number of patients with change in hepatitis B surface antigen titers from baseline for those with HBV DNA <1000 IU/ml(12 months)
- Number of patients with Incidence of seroconversion from Hepatitis B surface antigen to anti-Hepatitis B surface antibody(12 months)
研究者
研究点 (1)
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