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.: PACTR202302478939306 Date of Approval: 06/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Nigella Sativa cardioprotective effect in Type 1 diabetes
Official scientific title Possible cardioprotective effect of Nigella Sativa in Type 1 diabetes
Brief summary describing the background and objectives of the trial Diabetic cardiomyopathy (DCM) is a distinct clinical entity of diabetic heart muscle that describes diabetes-associated changes in the structure and function of the myocardium in the absence of coronary artery disease, hypertension, and valvular disease. The development of DCM is multifactorial and several pathophysiologic mechanisms have been proposed to explain structural and functional changes associated with DCM including hyperglycemia, oxidative stress and inflammation. Oxidative stress plays a critical role in DCM development. It has numerous deleterious effects on the cardiovascular system through direct cellular damage of proteins and DNA in addition to activation of apoptosis . The inflammatory mediators can modulate cardiac function, stimulate apoptosis and contribute to the development of DCM. Nigella sativa is a widely used medicinal plant throughout the world with a long history of use of the raw seeds as well as oil in medicines and food. Nigella sativa (N. sativa) has been reported to possess hypoglycemic, hypolipidemic and antioxidant properties Previous clinical studies reported that N sativa significantly decreases plasma lipid concentration (total cholesterol, LDL, and TG) in adults and may have effects on major cardiovascular risk factors.The aim of this study is to determine the possible cardioprotective effect of Nigella sativa type 1 diabetic children and adolescents.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/02/2023
Actual trial start date 11/02/2023
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Treatment group with Nigella Sativa 450 mg twice daily 3 months Children and adolescents with type 1 DM will receive Nigella Sativa 460 mg twice daily for 3 months in addition to insulin therapy. Echocardiography and laboratory tests will be performed before and after treatment 30
Control Group none No Nigella Sativa will be received only insulin therapy 3 months Children and adolescents with type 1 DM will receive placebo twice daily in addition to insulin therapy . Echocardiography and laboratory tests will be performed at base line and after 3 months. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Type 1 diabetes children and adolescents with age 6-18 years Clinical evidence of heart failure coronary artery disease systemic hypertension rheumatic fever cardiomyopathy, The use of any medication other than insulin known to affect cardiac function (such as digitalis, angiotensin converting enzyme inhibitor, or β-blocker) Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 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 18/12/2022 Research ethics committee Faculty of Medicine Tanta Univerisity FWA00022834 IRB0010038
Ethics Committee Address
Street address City Postal code Country
Elgheish Street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cardiac function by echocardiography At baseline and afters 3 months
Secondary Outcome Serum level of malondialdhyde, nitric oxide, TNF-α and the cardiac marker troponin I. At baseline and afters 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Elgheish Street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dalia El Afify Elgheish street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Mediine Tanta Unversity Elgheish Street Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Doaa El Amrousy Elmotasem street Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dalia El Afify daliaelafify@yahoo.com 00201006831093 Elgheish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assisstant Professor of Clinical Pharmacy
Role Name Email Phone Street address
Scientific Enquiries Doaa El Amrousy doaamoha@yahoo.com 00201289022229 elmotasem street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of Pediaterics
Role Name Email Phone Street address
Public Enquiries Wael El Feky waelfeky@yahoo.com 00201004332200 El nile street
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of Cardiothoracic surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol and IPD data will be shared in a word document format as summary of results upon reasonable request Statistical Analysis Plan within 12 months of the end of the study controlled access after approval of the authors
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