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.: PACTR202310875852492 Date of Approval: 03/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Black seed (Nigella sativa) in the management of Type 2 Diabetes
Official scientific title Efficacy of Black seed (Nigella sativa) in the management of Type 2 Diabetes
Brief summary describing the background and objectives of the trial Type 2 diabetes mellitus (T2DM) remains a global health problem with increasing prevalence yearly. This has led to reduced quality of life associated with macrovascular complications as a result of oxidative stress initiated by Hypoglycemia. Uses of functional food like Nigella sativa have been shown to reduce oxidative stress in T2DM patients. This study aims to explore the efficacy of Nigella sativa in the management of T2DM. The study will be a randomized control trial with two groups; Intervention(NS) and control group (C). Nigella sativa (1g) will be given to the NS group in doses of 500mg twice per day for three months while the C group will receive a placebo of 1g; in a dosage of 500mg daily for three months. Baseline data that include patient characteristics; social demographic and social economic; dietary intake and physical activity data will be collected. Pre-intervention and post-intervention data will include, HbA1c, Lipid profile, anthropometric (Body mass index; MI, Waist circumference; WC; Waist hip ratio; WHR; body fat); glutathione levels (GSH) and Tumor necrotic factor (TNF-𝜶). Data will be analyzed using statistical package for Social Sciences (SPSS) software. Data on demographic and medical history will be presented using descriptive statistics and results compared between groups using the chi-square test and logistic regression. Manna Whitney and independent t-test will be used to compare mean values between the groups at baseline. Analysis of variance (ANOVA) will be used to compare means between groups after the intervention. The primary outcome measure will be mean changes in HbA1c; while the secondary outcome measure will be mean change in, anthropometric indices, lipid profile, GSH, and TNF-𝜶. Results from this study will provide empirical evidence on the usefulness of Nigella sativa in the management of T2DM patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BLACKSEED STUDY
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/09/2022
Actual trial start date 13/10/2022
Anticipated date of last follow up 22/12/2022
Actual Last follow-up date 31/01/2023
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status Completed
Publication URL not Applicable
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 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
Experimental Group nigella sativa group 2grams per day of black cumin seed powder in the form of capsules each 500mg -2 capsules in the morning and 2 in the evening 3 months The participants in the experimental group were given Nigella sativa (Black seed) powders in the form of capsules packaged with 500mg in doses of 2 grams per day-2 capsules in the morning and 2 capsules in the evening 25
Experimental Group B GROUP 2.5 grams given in doses of 1 gram (2 capsules of 500mg each) in the morning and 1.5 grams (3 capsules of 500 mg each) in the evening 3 months Intervention group where participants were given 2.5 g of Nigella sativa for three months with supply being given monthly 25
Control Group control group Cgroup 2 g of activated charcoal distributed 1 gram in the morning( 2*500mg capsules in the morning and evening) 3 months the participants were given activated charcoal that acted as a placebo with doses of 2 capsule of 500mg in the morning and evening 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All participants with Type 2 diabetes attending care at Gatundu Level 5 Hospital Non-communicable Disease Center who consented to participate and signed a written informed consent. Type 2 diabetes patient attending care at Gatundu Level 5 Hospital Non-communicable Disease Center WHO HAD COMPLICATION SUCH AS RENAL FAILURE, STROKE. Those who did not consent Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 79 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 04/08/2022 Jomo Kenyatta University of Agriculture and Technology Instittional Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
62000-Nairobi Nairobi 00200 Kenya
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 04/08/2022 Jomo Kenyatta University of Agriculture and Technology Instittional Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
62000-Nairobi Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean change in HbA1C 3 months post intervention after 3 months post intervention
Secondary Outcome Mean changes in Lipid profile--Triglycerides, total cholesterol, high density lipo-protein and low density lipo-protein post intervention after 3 months post intervention
Secondary Outcome mean changes in Tumor necrotic factor post intervention after 3 months post intervention
Secondary Outcome mean change in antioxidant factor-vitamin C and glutathione level post intervention after 3 months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gatundu Level 5 Hospital Gatundu kiambu Nairobi 01000 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
African ai Japan Project JICA KENYA 62000 JKUAT-JUJA NAIROBI 00200 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor African ai Japan project JICA JKUAT PAUSTI 62000-JKUAT-JUJA NAIROBI 00200 Kenya Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ANN THUITA WAMBUGU ann.thuita@jkuat.ac.ke +254721783766 62000-JKUAT JUJA
City Postal code Country Position/Affiliation
NAIROBI 00200 Kenya Jomo Kenyatta University of Agriculture and Technology
Role Name Email Phone Street address
Public Enquiries ANN THUITA WAMBUGU ann.thuita@jkuat.ac.ke +254721783766 62000-JKUAT JUJA
City Postal code Country Position/Affiliation
NAIROBI 00200 Kenya Jomo Kenyatta University of Agriculture and Technology
Role Name Email Phone Street address
Scientific Enquiries ANN THUITA WAMBUGU ann.thuita@jkuat.ac.ke +254721783766 62000-JKUAT JUJA
City Postal code Country Position/Affiliation
NAIROBI 00200 Kenya Jomo Kenyatta University of Agriculture and Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data will be shared after completion of the study Informed Consent Form,Study Protocol 24 month following completion of the study implementation Publication
URL Results Available Results Summary Result Posting Date First Journal Publication Date
no publication yet 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