An interventional study of Sativa Nigra oil Softgels and Activated Charcoal Softgels in Diabetes Mellitus, sponsored by Sulaiman AlRajhi Colleges. Status unknown at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-14.
Sponsored by Sulaiman AlRajhi Colleges · Not applicable, Interventional, and Treatment
Diabetes mellitus is a growing global concern with significant health and financial burdens. The Kingdom of Saudi Arabia is one of the world's top 10 countries with the highest diabetes prevalence. Strict blood glucose control is an important measure in the treatment of diabetes and prevention of its complications. The scientific community has recently shown a profound interest in the area of complementary and alternative medicine where a ton of research is being conducted. The primary focus of this field of research is subjecting many of the medicinal plants used in herbalism to the scientific methodology of testing. In order for these plants to be implemented in treatment protocols, their effect must be clearly proven and documented scientifically. This study aims to investigate the effect of daily consumption of black seed oil on the blood sugar levels of healthy adults.
Research Question and Objectives:
Research question: Will daily consumption of 2g of N. sativa extract oil improve (decrease) fasting blood glucose levels of adults?
Research Objectives:
Primary: To conduct a feasibility study investigating the effect of daily consumption of 2g of N. sativa extract oil on the fasting blood glucose levels of adults.
Secondary: To investigate the effect of daily consumption of 2g of N. sativa oil extract on blood pressure.
Secondary: To investigate the feasibility of regular black seed oil intake by means of gastrointestinal symptoms questionnaire
Trial Design:
Design: This is a placebo-controlled double-blinded randomized controlled trial with two parallel groups.
Allocation: The randomization will substantially reduce the risk of selection bias and confounding factors. Simple randomization will be used in this study. This randomization will insure a balanced 1:1 allocation ratio at the end of sample recruitment. A computer program will be used to generate a set of random numbers, an allocation sequence. Each number assigns the participant either to the intervention or the control group. However, this information will only be revealed after a sealed opaque file is opened at the time of recruitment.
Framework: Exploratory study to gather preliminary information on the intervention and the feasibility of its use in blood glucose control.
Study Setting:
This study will be conducted in the internal clinics of Sulaiman Al Rajhi Colleges in Qassim region, Kingdom of Saudi Arabia.
Participants Timeline:
The primary outcome (Fasting blood glucose, FBG) will be assessed three times during the study period. FBG measurement moments for each participant are at 0, 2, and 4 weeks from the time of randomization. The rationale behind spacing measuring moments two weekly is to allow a sufficient response time for FBG levels to be interpretable. Secondary outcomes will be assessed weekly totaling five assessments at 0, 1, 2, 3 and 4 weeks from the time of randomization. The participant will have to visit the College internal clinics at his or her respective measurement points. The participant will be reminded the night before to remain fasting for at least 6 hours before the visit. At each visit, the participant will initially answer a set of questions to assess the degree of compliance and adherence. He or she then will be asked to report any possible side effects and will be allowed a time to fill in the questionnaires and express any concerns he or she might have. Next, blood pressure will be measured. Finally, a venous blood sample will be taken to measure the fasting blood glucose.
Recruitment:
The participants in this study are going to be recruited form Sulaiman Al Rajhi Colleges, Al-Qassim, Kingdom of Saudi Arabia. Multiple channels will be used to recruit subjects including but not limited to: invitation posters/flyers, E-mails and social media. Prospective participants will be subjected to our inclusion/exclusion criteria to determine their eligibility and finalize their recruitment and randomization. Each participant will have to provide a written informed consent in order be enrolled.
Primary outcome: Trained personnel will be responsible for obtaining venous blood samples from all subjects in a controlled and private environment. Each sample will be labeled with the participant's unique identification code and sent immediately to a cooperating external lab equipped with advanced and accurate devices.
Secondary outcomes: Each participant will have his or her blood pressure measured privately in the internal clinic by trained personnel using a standardized sphygmomanometer. The side effects of the intervention will be assessed by means of a questionnaire specifically developed for the purpose. The use of a standardized questionnaire is not necessary since the data is not intended to diagnose or categorize any particular health condition.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Sulaiman AlRajhi Colleges is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
A total of 15 subjects randomly allocated to the treatment arm will receive 2000mg a day of 'Sativa Nigra oil' softgels for 30 consecutive days. The total daily dose is divided in 4 doses taken 6 hourly (each softgel contains 500mg). This supplement is manufactured by \[Bioextract Ltd, Sri Lanka\] and is available commercially.
Dietary Supplement: Sativa Nigra oil Softgels
Subject randomly allocated to the control arm will receive 1040mg a day of activated charcoal softgels for 30 consecutive days. The total daily dosage is divided in 4 doses taken 6 hourly (each softgel contains 260mg). This supplement is manufactured by \[Arkopharma Pharmaceutical Laboratories\] and is available commercially.
Dietary Supplement: Activated Charcoal Softgels
Nigella sativa, a flowering plant native to southwest Asia, is considered one of the most important healing medicinal plants in Islamic culture. The use of its richly colored black seeds has been recommended in the prophetic medicine. It's also known by various other names amongst different cultures. Importantly, its seed is known in Arabic as 'habat al Baraka' which translates literally to 'the seed of blessing'.The active ingredient is believed to be thymoquinone richly present in the oil extract of its seeds. Apart from mild occasional gastrointestinal disturbance, black seed oil has no side effects and is considered very safe. .
Also known as: Blackseed oil softgels
This supplement is manufactured by \[Arkopharma Pharmaceutical Laboratories\] and is available commercially. The use of activated charcoal softgels as a placebo is documented in several other clinical trials. The single most relevant characteristic of charcoal is its minimal if any gastrointestinal absorption. As a result, it does not undergo any metabolism and is excreted completely in feces. This makes charcoal an attractive placebo choice for small trials or when manufacturing a specific placebo is not feasible. Charcoal softgels are black in color and resemble black seed oil softgels to a great extent.
Fasting venous blood glucose
The change from baseline in fasting venous blood glucose after 1 month of intervention. The participant-level analysis is change from baseline at 1 month and the method of aggregation for each study group is the mean.
Time frame: The primary outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
Blood pressure
the change from baseline in mean seated blood pressure after 1 month of intervention. The participant-level analysis is change from baseline at 1 month and the method of aggregation for each study group is the mean
Time frame: This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
Gastrointestinal symptoms
The proportion of subjects reporting significant gastrointestinal symptoms defined as moderate or severe in the questionnaire.
Time frame: This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
Plan to share: No
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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Sulaiman AlRajhi Colleges