The Effect of 2 Grams Daily Supplementation of Sativa Nigra Oil on Blood Glucose Levels of Adults.
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|ClinicalTrials.gov Identifier: NCT03776448|
Recruitment Status : Not yet recruiting
First Posted : December 14, 2018
Last Update Posted : December 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Dietary Supplement: Sativa Nigra oil Softgels Dietary Supplement: Activated Charcoal Softgels||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Both participants and researchers involved directly in collecting data (ex. Measuring blood pressure or interviewing subjects) will be unaware of the allocation status and thus blinded. However, statistical analysts and those who will provide the participants with the intervention/placebo will be aware of the allocation status. All interventions (black seed oil and charcoal softgels) will be supplemented in neutral identical containers. Each participant will receive a container labeled with his or her specific identification code and containing the intervention for the arm to which he or she has been allocated.|
|Official Title:||The Effect of 2 Grams Daily Supplementation of Thymoquinone -Containing Sativa Nigra Oil on Blood Glucose Levels of Adults: A Placebo-controlled Double-blinded Randomized Controlled Trial|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Experimental: Sativa Nigra oil arm
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
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. .
Other Name: Blackseed oil softgels
Placebo Comparator: The charcoal arm
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
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 [ Time Frame: The primary outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention ]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.
- Blood pressure [ Time Frame: This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention ]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
- Gastrointestinal symptoms [ Time Frame: This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention ]The proportion of subjects reporting significant gastrointestinal symptoms defined as moderate or severe in the questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776448
|Contact: Nazmus Saquib, Phd||699 email@example.com|
|Contact: Ahmed Abduljalil||699 firstname.lastname@example.org|
|Sulaiman AlRajhi Colleges||Not yet recruiting|
|Al Bukairiyah, Qassim, Saudi Arabia, 51941, PO Box 777|
|Contact: Nazmus Saquib, Phd 966 533445899 email@example.com|
|Principal Investigator: Nazmus Saquib, Phd|
|Sub-Investigator: Ahmed Abduljalil|
|Principal Investigator:||Nazmus Saquib, Phd||SRC|