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.: PACTR201804003215168 Date of Approval: 19/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title event related evoked potential versus clinical tests in assessment of subclinical cognitive impairment in chronic hepatitis c virus
Official scientific title event related evoked potential versus clinical tests in assessment of subclinical cognitive impairement in chronic hepatitis c virus
Brief summary describing the background and objectives of the trial chronic infection by hepatitis c virus causes impairment in neurocognitive function in up to 50% of patients which may not detected by clinical tests. Objectives: early detection of neurocognitive impairment in chronic hepatitis c patients and investigating the cognitive function in hepatitis c virus patients by p300 and clinical trials.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HCV- cognitive function,Mental and Behavioural Disorders,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/06/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 31/01/2018
Actual Last follow-up date 31/01/2018
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using a radomisation table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group p300 once 2hours Nihon Kohen Neuropack MEB was used. Electrophysiological activity was recorded from 3 different positions. Stimuli introduced through head phone. Subjects detected or counted the target stimuli 60
Control Group p300 once 2hours Nihon Kohen Neuropack MEB was used. Electrophysiological activity was recorded from 3 different positions. Stimuli introduced through head phone. Subjects detected or counted the target stimuli 30
Experimental Group MMSE score once 3 hours we assess the total MMSE score where 25-30 nomal. 20-24 mild cognitive impairement. 19-11 moderate cognitive impairement 60
Control Group MMSE score once 3 hours we use the M probe. The patient in supine position. the probe on the lower ribs. we pressed the probe button. The measurment were taken 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Chronic hepatitis c patient High level of education Patients with other causes for chronic liver disease except HCV Psychiatric disorders Ascites Obesity Renal failure diabetes Drug abuse 18 Year(s) 55 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 01/04/2017 Minia university- Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Minia university Minia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cognitive function impairment 2 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia University hospital Minia University hospital street Minia 61519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minia university hospital Minia University hospital street Minia 61519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Elham Ahmed Mohammed Minia University hospital street Minia 61519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Elham Ahmed Mohammed Minia University hospital street Minia 61519 Egypt
Hanaa Kalaf Fath El Bab Minia University hospital street Minia 61519 Egypt
Wail Talaat Soliman Minia University hospital street Minia 61519 Egypt
Dina Fathy Mansour Minia University hospital street Minia 61519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elham Ahmed elhamo2011@yahoo.com 01003539887 Minia university hospital
City Postal code Country Position/Affiliation
Minia 61519 Egypt lecturer MD
Role Name Email Phone Street address
Public Enquiries Elham Ahmed elhamo2011@yahoo.com 01003539887 Minia university hospital
City Postal code Country Position/Affiliation
Minia 61519 Egypt lecturer MD
Role Name Email Phone Street address
Scientific Enquiries Elham Ahmed elhamo2011@yahoo.com 01003539887 Minia university hospital
City Postal code Country Position/Affiliation
Minia 61519 Egypt lecturer MD
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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