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.: PACTR202101703883803 Date of Approval: 20/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of The Therapeutic Role of Coenzyme Q10 and Coconut Oil in Acute Aluminum Phosphide Poisoning Outcomes:A Randomized Controlled Clinical Trial
Official scientific title Evaluation of The Therapeutic Role of Coenzyme Q10 and Coconut Oil in Acute Aluminum Phosphide Poisoning Outcomes:A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial The aim of this study is to evaluate the efficacy and safety of Coenzyme Q10 and coconut oil in acute aluminum phosphide poisoning outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/11/2020
Actual trial start date 01/12/2020
Anticipated date of last follow up 01/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group the standered supportive care plus lavage with coconut oil and Coenzyme Q10 lavage will be done using 50 ml of coconut oil and repeated until lavage become clear the total daily CoQ10 dose is 1200 mg. It will be divided into 2 doses: Initial 600 mg dissolved in coconut oil after gastric lavage followed by 600 mg after 12 hours of initial dose. coconut oil until lavage becomes clear Coenzyme Q 10 for 12 h in two divided dose in addition to the standard supportive treatment that includes patient resuscitation, good oxygenation, supporting circulation with vasopressors and adequate hydration gastric lavage will be performed using coconut oil after gastric content aspiration through a nasogastric tube wherever possible or orally administered to those who refuse gastric lavage, the total daily CoQ10 dose is 1200 mg. It will be divided into 2 doses: Initial 600 mg dissolved in coconut oil after gastric lavage followed by 600 mg after 12 hours of initial dose. 28
Control Group The standered treatment 2 ampules of sodium bicarbonate added to each 500 ml saline activated charcoal in a dose of 1 g/Kg, orally. lavage continued until becomes clear patients will receive the standard and routine therapy after admission according to Tanta university poison control center protocol as follows: patient resuscitation, good oxygenation, and supporting circulation with vasopressors and gastric decontamination (with sodium bicarbonate and activated charcoal in a dose of 1 g/Kg, orally , adequate hydration and other supportive treatment. 28 Active-Treatment of Control Group
Control Group the standered supportive measurements plus coconut oil Lavage will be done using 50 ml of coconut repeated until lavage becomes clear until lavage becomes clear patents will receive coconut oil in addition to the standard treatment including patient resuscitation,good oxygenation, and supporting circulation with vasopressors adequate hydration and other supportive treatment.Gastric lavage will be performed using coconut oil after gastric content aspiration through a nasogastric tube wherever possible or orally administered to those who refuse gastric lavage . 28 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All acute ALP poisoned patients of both sexes admitted to Tanta university poison control center within 6 hours delay after ingestion and fit for gastric lavage will be enrolled in this study. • Asymptomatic patients • Pregnant and lactating women • Patients with combined drug/chemical ingestion in addition to aluminum phosphide. • Patients with chronic diseases (e.g. cardiovascular disease, renal or hepatic failure, infection, and cancer). • Patients with a disturbed consciousness level • Patients with post-cardiac arrest patients with ALP inhalation Patents with previous medical interventions before coming 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 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 21/11/2020 the Research Ethics Committee of Tanta Faculty of Medicine.
Ethics Committee Address
Street address City Postal code Country
elgesh street tanta 34282 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mortality rate period of hospital stay
Secondary Outcome • Need for intubation and mechanical ventilation. • Need for ICU admission • Duration of hospital stay • Total dose of needed inotropes period of hospital stay
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University poison control center Elgesh street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rasha Elhussieny El kornish street tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rasha Elhussieny Elsharkawy El kornish tanta Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mona mohamed heshmat Hassan Radwan street Tanta Egypt
Ayman Nagy Hala Tawfeek street Tanta Egypt
Ghada Nabil Botros street Tanta Egypt
Mona Ghoniem El shon street El mahala Elkobra Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rasha Elhussieny rashaelhussieny5@gmail.com 00201010797192 Elkornish
City Postal code Country Position/Affiliation
tanta Egypt assistant lecturer of forensic medicine and clinical toxicology
Role Name Email Phone Street address
Scientific Enquiries Ghada Nabil ghada.mahmoud1@med.tanta.edu.eg 00201004997450 Botros
City Postal code Country Position/Affiliation
tanta Egypt Ass. Professor of Forensic Medicine and Clinical toxicology
Role Name Email Phone Street address
Public Enquiries Mona Ghonaim mona.ghonaim@med.tanta.edu.eg 00201064257070 elshon
City Postal code Country Position/Affiliation
el mahala el kobra Egypt ass.prof of forensic medicine and clinical toxicology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes recorded data of patients in the trial Study Protocol one year All acute ALP poisoned patients aged more than 12 years of both sexes admitted to Tanta university poison control center within 6 hours delay after ingestion and fit for gastric lavage will be enrolled 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