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.: PACTR201911790018554 Date of Approval: 11/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of the Cardio protective Effect of Melatonin in Acute Aluminum Phosphide Poisoning: A Randomized Clinical Trial
Official scientific title Evaluation of the Cardio protective Effect of Melatonin in Acute Aluminum Phosphide Poisoning: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Aluminum phosphide is a common self-poisoning agent in Egypt due to their low price and easy availability(3).It is present in either tablet or powder forms. The aim of this study is to evaluate the protective effect of melatonin on the cardiotoxicity induced in cases of acute aluminum phosphide poisoning.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied aluminum phosphide poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2019
Actual trial start date 01/04/2019
Anticipated date of last follow up 01/08/2020
Actual Last follow-up date 01/09/2020
Anticipated target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group melatonin 20 mg single dose oral tablets 60 Dose Comparison
Experimental Group melatonin 20 mg two doses oral tablets 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All admitted cases above 18 years with acute aluminum phosphide poisoning will be included in this study. • Cases ingested or exposed to other substances in addition to the phosphide. • Cases with delayed presentation. • Cases with pre-exciting disease (e.g. cardiovascular disease, renal Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 25/08/2018 ethical committee of tanta university
Ethics Committee Address
Street address City Postal code Country
el bahr street tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome o Determination of troponin I level and Arterial Blood Gases and o Lipid peroxidation (LPO) assessment o Total antioxidant capacity assessment after 2 hours
Secondary Outcome • Mortality. • Need for ventilation. • Duration of hospital stay at discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta poison control centre el gish street tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
fatma gaber ahmed sobeeh el nady street tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor fatma gaber sobeeh el nady street tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator fatma gaber drfatmagaber1@yahoo.com +201090147026 el nady
City Postal code Country Position/Affiliation
tanta 31527 Egypt faculty of medicine tanta university
Role Name Email Phone Street address
Scientific Enquiries mervat mondy oreby orebya@gmail.com +201001217686 el nady
City Postal code Country Position/Affiliation
tanta 31527 Egypt faculty of medicine tanta university
Role Name Email Phone Street address
Public Enquiries rabab el kelany rababkelany@yahoo.com +201001957313 hasan radwan
City Postal code Country Position/Affiliation
tanta 31527 Egypt faculty of medicine tanta university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes recorded data of patients in the trial Study Protocol 8 months All admitted cases above 18 years with acute aluminum phosphide poisoning will be included in this study.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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