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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201810495738292 Date of Registration: 15/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effects of Nigella Sativa on Sickle Cell Disorders
Official scientific title The Effects of Nigella Sativa on Sickle Cell Disorders among Sudanese Children at Fath Alrahman Albasheer Outpatient Clinic, Khartoum, Sudan 2018-20
Brief summary describing the background and objectives of the trial Sickle cell disease is the most Prevalent human hereditary disorder with prominent morbidity and mortality. Nigella Sativa extract is safe, available, cheap, and can be easily administered. The antisickling effect of Nigella sativa on sickle cell disorders was reported but was not studied invivo. Studying the effect of Nigella sativa on the renal system of sicklers is of particular interest because renal impairment impacts the morbidity and mortality. The hematological changes are of special importance because hematological manifestations are central in the pathophysiology of the disease. The general objective of this study is to investigate the effects of Nigella sativa on patients with sickle cell disease with special emphasis on the renal and hematological systems. Specific objectives are to investigate the effects of Nigella sativa aqueous extracts on: i. Hematological parameters in patients with sickle cell disease. ii. Pulmonary Function patients with sickle cell disease. iii. Total and fetal hemoglobin concentration in patients with sickle cell disease. iv. GFR (glomerular filtration rate) in patients with sickle cell disease.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 07/11/2018
Actual trial start date
Anticipated date of last follow up 27/03/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
033308 Research ethics committee/ National medicines and poisons board/ Federal Ministry of Health
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard management according to wight 8 weeks Standard treatment 40 Active-Treatment of Control Group
Experimental Group Standard treatment alongside Nigella Sativa 2 gm once/ day for participants aging 5 - less than 13 years 4 gm once/ day for participants aging 13 to 18 years 8 weeks Nigella Sativa powder formulated into hard capsules given orally 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with sickle cell disease ages range between (5- 18) years, will be recruited for the study during their consultation at FathAlrahmaan Albasheer outpatient clinic. Patients with comorbidities like: hepatitis HIV end-stage renal disease Adolescent: 13 Year(s)-17 Year(s),Child: 6 Year-12 Year 5 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 27/02/2018 Drugs and poisons board research ethics committe
Ethics Committee Address
Street address City Postal code Country
Alsiteen street Almamoora Khartoum 11111 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Overall clinical status Reduction in hospital admissions, school absentees, blood transfusion, vaso-oclusive and painful episodes. 4 weeks intervals
Primary Outcome an increase in total hemoglobin and hemoglobin F concentration 4 weeks intervals
Secondary Outcome Pulmonary function an improvement in lung function measurements 4 weeks intervals
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fath Alrahman Albasheer outpatient clinic 21 October street Khartoum 11111 Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
National Ribat University Nile street Khartoum 11111 Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Ribat University Nile Street Khartoum 11111 Sudan University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Enas Shareef drenasshaareef@gmail.com +249115140720 Nile street
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan National Ribat University Faculty of Medicine lecturer at department of physiology
Role Name Email Phone Street address
Scientific Enquiries Enas Shareef drenasshaareef@gmail.com +249115140720 Nile street
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan National Ribat University faculty of medicine lecturer at department of physiology
Role Name Email Phone Street address
Scientific Enquiries Omer Musa omusa56@yahoo.co.uk +249912391297 Nile street
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan National Ribat University faculty of medicine professor at department of physiology
Role Name Email Phone Street address
Scientific Enquiries Mohammed Altohami drmohdomer@gmail.com +249923278356 Al-gasr Street
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan University of Khartoum faculty of medicine Assistant professor at department of pathology
Role Name Email Phone Street address
Public Enquiries Enas Shareef drenasshaareef@gmail.com +249115140720 Nile street
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan National Ribat University Faculty of medicine lecturer at department of physiology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all IPD that underlie results in a publication Statistical Analysis Plan,Study Protocol for 6 months 8 months after publication
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