A Randomized Controlled Trial Assessing the Efficacy and Safety Profile of Oral Ziliv Among Patients with Hepatic Disease Attending the Gastrointestinal Clinic of the Lagos University Teaching Hospital, Idi-Araba
Phase 4
Recruiting
- Conditions
- Digestive SystemHEPATOLOGY-LIVER HEALTH
- Registration Number
- PACTR202107709749875
- Lead Sponsor
- Zifam Pinnacle Nigeria Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. All consenting adults (male or female) subjects aged 18years and above.
2. All subjects with elevated alanine aminotransferase (ALT) enzyme levels of at ;least 1.5 times upper limit normal.
Exclusion Criteria
1. Subjects less than 10years old.
2. Hepatic malignancies (primary or secondary).
3. Terminally ill patients.
4. Patients with history of advanced chronic kidney disease or on hemodialysis.
5. Patients already on other hepatic-tonic supplements
6. Patients who refuse to give to give consent.
7. Pregnant or breastfeeding mothers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with greater than or equal to 50 percent reduction of ALT. Overall improvement in well-being after completion of trial.
- Secondary Outcome Measures
Name Time Method Proportion with reduced liver enzymes ALT, AST, ALP and bilirubin from the baseline.