Antiviral effect of 3 herbs in chronic inactive carriers of hepatitis B virus- A randomized placebo controlled clinical trial.

Organic India0 个研究点目标入组 80 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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.

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