A study to determine if a Zinc therapy can help in recovery of Hepatitis E virus infection.
Phase 2
- Conditions
- Health Condition 1: null- Patients with Acute viral hepatitis due to HEV and Acute on chronic liver failure with HEV
- Registration Number
- CTRI/2017/12/010757
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion criteria (for AVH):
1)Age > 18 years with Acute viral hepatitis due to HEV
2)Duration of symptoms < 7 days
3)Written informed consent
Inclusion criteria (for ACLF)
1)Age > 18 years with Acute on chronic liver failure with HEV as acute precipitant.
2)Written informed consent
Inclusion criteria (for HEV-ALF)
1)Age > 18 years with Acute liver failure due to HEV.
2)Written informed consent from patient or relatives
Exclusion Criteria
1)Chronic renal insufficiency (creatinine level, > 2.0mg/dl)
2)Patients diagnosed with Acute Kidney Injury.
3)Respiratory insufficiency
4)Anaemia, haemoglobin < 8g/dl
5)Coexistent bacterial infection
6)Associated hepatocellular carcinoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) To study the effect of Zinc supplementation on recovery of liver function tests at the end of 1st week and 2nd weekTimepoint: 1) End of 1st week and 2nd week
- Secondary Outcome Measures
Name Time Method 1) To evaluate the effect of Zinc supplementation on the duration of HEV viremia (Stool and Blood) and cytokine profile. <br/ ><br>2) To evaluate the safety and efficacy of Zinc therapy in patients with HEV infection. <br/ ><br>Timepoint: day 0, 5, 10 and 15 <br/ ><br>