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.: PACTR202404706815223 Date of Approval: 26/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of Liquid Chlorophyll As Adjuvant Therapy In Children With Beta Thalassemia
Official scientific title Role of Liquid Chlorophyll As Adjuvant Therapy In Children With Beta Thalassemia
Brief summary describing the background and objectives of the trial Thalassemia is a group of genetic disorders resulting from defects in the rate of synthesis of globin chains in haemoglobin molecule. Blood transfusion therapy is a lifesaving treatment for these patients. However, the complication of this therapy is iron overload caused by recurrent blood transfusion which transmits 200 to 250 mg of iron to the patient's body per unit. The mechanism involved in iron overload damage has been thought to be associated with oxidative stress or excessive reactive oxygen species (ROS) generation. Chlorophyll has a porphyrin ring similar to that of heme in haemoglobin.Chlorophyll has antioxidant activity; it has the ability to scavange long lived free radicals.The aim of this study is to evaluate role of liquid chlorophyll as adjuvant therapy in children with beta thalassemia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/05/2024
Actual trial start date
Anticipated date of last follow up 15/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Not yet 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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo 5 ml once daily 6 months placebo 35 Placebo
Experimental Group Liquid chlorophyll Liquid chlorophyll oral syrup will be given 5 ml once daily with a glass of water , the drug concentration is (100 mg/5ml) for 6 months Adjuvant treatment 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with β- thalassemia aged 1 -18 years 1.Children with β- thalassemia who are not compliant with liquid chlorophyll therapy. 2.Children with β- thalassemia who are allergic to liquid chlorophyll. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 1 Year(s) 18 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 24/01/2024 Faculty of medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El-Gharbia Governorate,Tanta . El-Gash st Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome frequency of blood transfusion, CBC parameters, serum ferritin level in both groups 0 , 3 , 6 months after liquid chlorophyll.
Secondary Outcome Liquid chlorophyll side effects 3,6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital El-Gharbia Governorate, El-Gash st Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No fund source Al Gharbia Governorate , Al Gash st Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University Al Gharbia Governorate Al Gash street Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Eman Mohammed Elaskary El Gharbia Governorate Al Gash st Tanta 31527 Egypt
Ibrahim Mohammed Badraia El Gharbia Governorate Al Gash st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Elaskary eman_elaskary@yahoo.com +201003007638 El Gharbia Governorate Al Gash st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Pediatrics
Role Name Email Phone Street address
Public Enquiries Ibrahim Badraia mohambadraia@gmail.com +201002169369 El Gharbia Governorate ,Al Gash street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of Pediatrics
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Badraia mohambadraia@gmail.com +201002169369 El Gharbia Governorate ,Al Gash street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of Pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share deidentified individual trial participant data. All of the individual participant data collected during the trial and after deidentification will be available for anyone who wishes to access the data for any purpose. Statistical Analysis Plan,Study Protocol After completion of the research and publication of the paper on request
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