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.: PACTR201609001765772 Date of Approval: 05/09/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Ginkgo biloba in HCV-patients
Official scientific title The Clinical Outcome of the Combination Regimen of Ginkgo biloba Extract with Ursodeoxycholic acid in Chronic Hepatitis C Egyptian Patients
Brief summary describing the background and objectives of the trial This study is designed to evaluate the clinical efficacy and safety of Ginkgo biloba (EGb) extract, ursodeoxycholic acid (UDCA) and their combination in chronic hepatitis C patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Hepatitis C,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 05/12/2012
Actual trial start date 05/12/2012
Anticipated date of last follow up 05/02/2015
Actual Last follow-up date 05/02/2015
Anticipated target sample size (number of participants) 67
Actual target sample size (number of participants) 60
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using random number generator mobile app Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using random number generator mobile app Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group extract of ginkgo biloba (EGb) 260 mg 12 weeks 1 capsule once daily 20
Experimental Group ursodeoxycholic acid (UDCA) 300 mg 12 weeks UDCA 300 mg 3 tablets/ day 20
Experimental Group extract of ginkgo biloba + ursodeoxycholic acid 260 mg of EGb and 300 mg of UDCA 12 weeks EGb 1 capsule once daily and UDCA 300 mg three times daily 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
positive serum anti-HCV Ab and HCV RNA clinical and ultrasonographic criteria suggestive of chronic hepatitis C Elevation of ALT at least 1.5 times the upper limit of normal (but < 5 times the normal limit) Child Pugh Grade A Child Pugh Grade was B or C had other causes of liver disease or had evidence of advanced liver disease e.g. history or presence of ascitis, bleeding esophageal varices, or hepatic encephalopathy. had portal vein thrombosis, hepatocellular carcinoma, seizure disorders body mass index >40 advanced systemic disease like heart failure or any debilitating disease that will affect life expectancy using oral contraceptive pills, selective serotonin reuptake inhibitors, narcotic drugs, blood thinning drugs or those who received a treatment of antiviral agents (interferon with or without ribavirin) in the previous 2 months. pregnancy or lactation patients with platelet level <50,000/µL patients with sensitivity to UDCA or EGb. 18 Year(s) 65 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 04/08/2014 ethics committe for experimental and clinical studies at Faculty of Pharmacy Ain Shams University
Ethics Committee Address
Street address City Postal code Country
monzmet elwe7da el africia Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome liver enzymes baseline after 12 weeks
Primary Outcome serum total antioxidant capacity baseline after 12 weeks
Primary Outcome serum transforming growth factor beta1 baseline after 12 weeks
Primary Outcome serum Hyaluronic acid baseline after 12 weeks
Primary Outcome International normalized Ratio (INR) baseline after 12 weeks
Secondary Outcome adverse effects after 12 weeks
Secondary Outcome complete blood count baseline after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of the Tropical Medicine Department, El-Demerdash Hospital, Ain Shams University Abbasyia Cairo Egypt
Yassin Abel GaffarCharity Center for Liver Diseases and Researches Nasr City Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No funding sources
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dina Mohamed kamal El-Gindy 9B Street 31, fourth area, fifth district, fifth settlement, New Cairo, Cairo, Egypt Cairo 11835 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Misr International University kilo 28 Cairo Ismailia Road, Orabi district Cairo 11341 Egypt
Faculty of Pharmacy Ain Shams University el Abbasyia Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dina El-Gindy dina_kamal25@hotmail.com 01223289088 9B Street 31, fourth area, fifth district, fifth settlement, New Cairo, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 11835 Egypt Misr International University
Role Name Email Phone Street address
Public Enquiries Dina El-Gindy dina_kamal25@hotmail.com 01223289088 9B Street 31, fourth area, fifth district, fifth settlement, New Cairo, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 11835 Egypt Misr International University
Role Name Email Phone Street address
Scientific Enquiries Dina El-Gindy dina_kamal25@hotmail.com 01223289088 9B Street 31, fourth area, fifth district, fifth settlement, New Cairo, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 11835 Egypt Misr International University
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information