Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202107709749875 Date of Approval: 21/07/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title 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
Official scientific title 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
Brief summary describing the background and objectives of the trial This study is to evaluate the potential efficacy and safety of oral Ziliv as a supportive treatment in liver disease, and to demonstrate the reduction in hepatic enzyme elevation in patients with hepatic disease attending the Gastroenterology clinic in Lagos University Teaching Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ZILIV STUDY
Disease(s) or condition(s) being studied Digestive System,HEPATOLOGY-LIVER HEALTH
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2021
Actual trial start date 03/06/2021
Anticipated date of last follow up 01/12/2021
Actual Last follow-up date 10/12/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cases Ziliv one capsule twice daily THREE MONTHS SCREEN FOR ELIGIBILITY. CONSENT ADMINISTERED HISTORY AND EXAMINATION FOR PRESENCE OF LIVER DISEASE BLOOD SAMPLES TAKEN--LIVER ENZYMES, CHEMISTRY AND FUNCTION, FULL BLOOD COUNT, CREATININE 50
Control Group CONTROL PLACEBO ONE TWICE DAILY FOR THREE MONTHS 3 MONTHS ELIGIBILTY. CONSENT. QUESTIONAIRE ADMINISTERED HISTORY AND EXAMINATION. SAMPLES TAKEN FOR LIVER ENZYMES, CHEMISTRY, LIVER FUNCTION, CREATININE, FULL BLOOD COUNT 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/02/2021 Lagos University Teaching Hospital Health Research Ethics Committee LUTH HREC
Ethics Committee Address
Street address City Postal code Country
PMB 12003, Ishaga Road, Surulere Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of patients with greater than or equal to 50 percent reduction of ALT. Overall improvement in well-being after completion of trial. 3 months
Secondary Outcome Proportion with reduced liver enzymes ALT, AST, ALP and bilirubin from the baseline. 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Ishaga Road, Surulere Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
ZIFAM PINNACLE NIGERIA LTD Ilupeju Bypass beside First Bank, Ilupeju Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zifam Pinnacle Nigeria Ltd Ilupeju Bypass beside First Bank, Ilupeju, Mushin Lagos Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ganiyat Oyeleke drgoyeleke@yahoo.com +2348025380385 Department of Internal Medicine, Lagos University Teaching Hospital
City Postal code Country Position/Affiliation
Lagos Nigeria Consultant Physician Gastroenterologist and Hepatologist
Role Name Email Phone Street address
Public Enquiries Abdulwasiu Busari busarial@yahoo.com +2348033011555 Department of Pharmacology, Therapeutics and Toxicology, College of Medicine, University of Lagos.
City Postal code Country Position/Affiliation
Lagos Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Emuobor Odeghe eaodeghe@yahoo.com +2348023166319 College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Lecturer and Consultant Gastroenterologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We plan to make IPD available. However only de-identified that underlie results in a publication will be shared. Data will be shared after publication of primary results. data will be made available to investigators whose proposed research has received IRB approval. Data will be available via a data repository following execution of data use agreement. Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of study completion. Available on request. Via data repository.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information