<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03776448</url>
  </required_header>
  <id_info>
    <org_study_id>SulimanAC-BlackseedOil</org_study_id>
    <nct_id>NCT03776448</nct_id>
  </id_info>
  <brief_title>The Effect of 2 Grams Daily Supplementation of Sativa Nigra Oil on Blood Glucose Levels of Adults.</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sulaiman AlRajhi Colleges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sulaiman AlRajhi Colleges</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes mellitus is a growing global concern with significant health and financial burdens.&#xD;
      The Kingdom of Saudi Arabia is one of the world's top 10 countries with the highest diabetes&#xD;
      prevalence. Strict blood glucose control is an important measure in the treatment of diabetes&#xD;
      and prevention of its complications. The scientific community has recently shown a profound&#xD;
      interest in the area of complementary and alternative medicine where a ton of research is&#xD;
      being conducted. The primary focus of this field of research is subjecting many of the&#xD;
      medicinal plants used in herbalism to the scientific methodology of testing. In order for&#xD;
      these plants to be implemented in treatment protocols, their effect must be clearly proven&#xD;
      and documented scientifically. This study aims to investigate the effect of daily consumption&#xD;
      of black seed oil on the blood sugar levels of healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Research Question and Objectives:&#xD;
&#xD;
           Research question: Will daily consumption of 2g of N. sativa extract oil improve&#xD;
           (decrease) fasting blood glucose levels of adults?&#xD;
&#xD;
           Research Objectives:&#xD;
&#xD;
           Primary: To conduct a feasibility study investigating the effect of daily consumption of&#xD;
           2g of N. sativa extract oil on the fasting blood glucose levels of adults.&#xD;
&#xD;
           Secondary: To investigate the effect of daily consumption of 2g of N. sativa oil extract&#xD;
           on blood pressure.&#xD;
&#xD;
           Secondary: To investigate the feasibility of regular black seed oil intake by means of&#xD;
           gastrointestinal symptoms questionnaire&#xD;
&#xD;
        2. Trial Design:&#xD;
&#xD;
           Design: This is a placebo-controlled double-blinded randomized controlled trial with two&#xD;
           parallel groups.&#xD;
&#xD;
           Allocation: The randomization will substantially reduce the risk of selection bias and&#xD;
           confounding factors. Simple randomization will be used in this study. This randomization&#xD;
           will insure a balanced 1:1 allocation ratio at the end of sample recruitment. A computer&#xD;
           program will be used to generate a set of random numbers, an allocation sequence. Each&#xD;
           number assigns the participant either to the intervention or the control group. However,&#xD;
           this information will only be revealed after a sealed opaque file is opened at the time&#xD;
           of recruitment.&#xD;
&#xD;
           Framework: Exploratory study to gather preliminary information on the intervention and&#xD;
           the feasibility of its use in blood glucose control.&#xD;
&#xD;
        3. Study Setting:&#xD;
&#xD;
           This study will be conducted in the internal clinics of Sulaiman Al Rajhi Colleges in&#xD;
           Qassim region, Kingdom of Saudi Arabia.&#xD;
&#xD;
        4. Participants Timeline:&#xD;
&#xD;
           The primary outcome (Fasting blood glucose, FBG) will be assessed three times during the&#xD;
           study period. FBG measurement moments for each participant are at 0, 2, and 4 weeks from&#xD;
           the time of randomization. The rationale behind spacing measuring moments two weekly is&#xD;
           to allow a sufficient response time for FBG levels to be interpretable. Secondary&#xD;
           outcomes will be assessed weekly totaling five assessments at 0, 1, 2, 3 and 4 weeks&#xD;
           from the time of randomization. The participant will have to visit the College internal&#xD;
           clinics at his or her respective measurement points. The participant will be reminded&#xD;
           the night before to remain fasting for at least 6 hours before the visit. At each visit,&#xD;
           the participant will initially answer a set of questions to assess the degree of&#xD;
           compliance and adherence. He or she then will be asked to report any possible side&#xD;
           effects and will be allowed a time to fill in the questionnaires and express any&#xD;
           concerns he or she might have. Next, blood pressure will be measured. Finally, a venous&#xD;
           blood sample will be taken to measure the fasting blood glucose.&#xD;
&#xD;
        5. Recruitment:&#xD;
&#xD;
           The participants in this study are going to be recruited form Sulaiman Al Rajhi&#xD;
           Colleges, Al-Qassim, Kingdom of Saudi Arabia. Multiple channels will be used to recruit&#xD;
           subjects including but not limited to: invitation posters/flyers, E-mails and social&#xD;
           media. Prospective participants will be subjected to our inclusion/exclusion criteria to&#xD;
           determine their eligibility and finalize their recruitment and randomization. Each&#xD;
           participant will have to provide a written informed consent in order be enrolled.&#xD;
&#xD;
        6. Data Collection:&#xD;
&#xD;
      Primary outcome: Trained personnel will be responsible for obtaining venous blood samples&#xD;
      from all subjects in a controlled and private environment. Each sample will be labeled with&#xD;
      the participant's unique identification code and sent immediately to a cooperating external&#xD;
      lab equipped with advanced and accurate devices.&#xD;
&#xD;
      Secondary outcomes: Each participant will have his or her blood pressure measured privately&#xD;
      in the internal clinic by trained personnel using a standardized sphygmomanometer. The side&#xD;
      effects of the intervention will be assessed by means of a questionnaire specifically&#xD;
      developed for the purpose. The use of a standardized questionnaire is not necessary since the&#xD;
      data is not intended to diagnose or categorize any particular health condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting venous blood glucose</measure>
    <time_frame>The primary outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms</measure>
    <time_frame>This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention</time_frame>
    <description>The proportion of subjects reporting significant gastrointestinal symptoms defined as moderate or severe in the questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Sativa Nigra oil arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The charcoal arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sativa Nigra oil Softgels</intervention_name>
    <description>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. .</description>
    <arm_group_label>Sativa Nigra oil arm</arm_group_label>
    <other_name>Blackseed oil softgels</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Activated Charcoal Softgels</intervention_name>
    <description>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.</description>
    <arm_group_label>The charcoal arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18-60&#xD;
&#xD;
          -  Regular Student or Faculty in Sulaiman Alrajhi Colleges&#xD;
&#xD;
          -  Consenting for intervention and follow up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type I diabetes or Insulin Therapy&#xD;
&#xD;
          -  Significant chronic medical illness&#xD;
&#xD;
          -  Current use of long-term prescription drugs&#xD;
&#xD;
          -  Current use of black seed oil&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nazmus Saquib, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>SRC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nazmus Saquib, Phd</last_name>
    <phone>699 533445899</phone>
    <email>a.saquib@sr.edu.sa</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Abduljalil</last_name>
    <phone>699 595449479</phone>
    <email>13110033@srcolleges.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sulaiman AlRajhi Colleges</name>
      <address>
        <city>Al Bukairiyah</city>
        <state>Qassim</state>
        <zip>51941, PO Box 777</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <contact>
      <last_name>Nazmus Saquib, Phd</last_name>
      <phone>966 533445899</phone>
      <email>a.saquib@sr.edu.sa</email>
    </contact>
    <investigator>
      <last_name>Nazmus Saquib, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ahmed Abduljalil</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Charcoal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03776448
org study id: SulimanAC-BlackseedOil
nct id: NCT03776448
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
1. 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

        2. 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.

        3. Study Setting:

           This study will be conducted in the internal clinics of Sulaiman Al Rajhi Colleges in
           Qassim region, Kingdom of Saudi Arabia.

        4. 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.

        5. 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.

        6. Data Collection:

      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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
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.
measure: Fasting venous blood glucose
time frame: The primary outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
description: 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.
measure: Blood pressure
time frame: This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
description: 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
measure: Gastrointestinal symptoms
time frame: This outcome will be assessed at 1 week, 2 weeks, 3 weeks and 4 weeks of intervention
description: The proportion of subjects reporting significant gastrointestinal symptoms defined as moderate or severe in the questionnaire.
arm group label: Sativa Nigra oil arm
arm group type: Experimental
description: 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.
arm group label: The charcoal arm
arm group type: Placebo Comparator
description: 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.
intervention type: Dietary Supplement
intervention name: Sativa Nigra oil Softgels
description: 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. .
arm group label: Sativa Nigra oil arm
other name: Blackseed oil softgels
intervention type: Dietary Supplement
intervention name: Activated Charcoal Softgels
description: 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.
arm group label: The charcoal arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nazmus Saquib, Phd
role: Principal Investigator
affiliation: SRC
last name: Nazmus Saquib, Phd
phone: 699 533445899
email: a.saquib@sr.edu.sa
last name: Ahmed Abduljalil
phone: 699 595449479
email: 13110033@srcolleges.org
facility: 
contact: 
investigator: 
investigator: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Charcoal
sharing ipd: No