xml: <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/NCT06029868</url>
    </required_header>
    <id_info>
      <org_study_id>IR.BUMS. REC.1398.020</org_study_id>
      <nct_id>NCT06029868</nct_id>
    </id_info>
    <brief_title>Black Seed Oil in Treatment of Osteoarthritis</brief_title>
    <official_title>Improving the Process of Dryness, Limited Movement, and Joint Pain Using the Black Seed in Osteoarthritis: a Randomized, Double-blind, Placebo-controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ramsar international campus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ramsar international campus</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Osteoarthritis is a continual illness of joints. We aim to investigate the effect of Nigella&#xD;
        sativa oil in comparison with placebo on the reduction of osteoarthritis pain.&#xD;
  &#xD;
        This study is a double-blinded, randomized, controlled trial study, conducting in Vali-e-Asr&#xD;
        Hospital in 2019, in Birjand, on patients with mild osteoarthritis. The Western Ontario and&#xD;
        McMaster Universities Osteoarthritis Index is applied to score the functional status of&#xD;
        participants' joints.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was a randomized controlled trial. Regarding to the inclusion criteria, 110&#xD;
        osteoarthritis patients were included in this study based on clinical signs, physical&#xD;
        examination and radiological signs. In the next step, a fully explanation was given to the&#xD;
        participants around the conditions of conducting the research, and then the informed consent&#xD;
        were collected. Subsequently, patients were randomly divided into two groups of recipients;&#xD;
        black seed soft gel capsules (intervention) and placebo equally in accordance with&#xD;
        demographic information. Furthermore, the two groups were randomly classified regarding to&#xD;
        age, consequently the study population was divided into subgroups of categorized ages.&#xD;
        Thereafter, an equal number of each subgroup was randomly selected and divided into two&#xD;
        groups to take black seed and placebo. Therefore, the two groups were similar, but the exact&#xD;
        membership of individuals in the groups were random. Due to the higher prevalence of&#xD;
        osteoarthritis among women in the community, the number of female cases were higher. It&#xD;
        should be noted that the experimenters as well as patients did not know who was receiving a&#xD;
        particular treatment (Double-blinded study). Prior to commencing the study, participants were&#xD;
        asked to take a regular 48-day course of anti-inflammatory therapy. The cases in the&#xD;
        intervention group took 700 mg of black seed soft gel capsule once a day from Gorgan&#xD;
        Essential Oil Pharmaceutical Company, and the control group were treated by placebo capsules&#xD;
        in the same-color and shape of the drug, with a taste of rice bran. Moreover, questionnaires&#xD;
        were filled to record demographic information of both groups including age, sex, history&#xD;
        medication and diet. The condition of participants were evaluated twice before the treatment&#xD;
        and 48 days after the onset of black seed. At the end of each period, joint pain scores, the&#xD;
        range of activity, and the dryness of the joints of all patients were assessed, and their&#xD;
        mean were measured.&#xD;
  &#xD;
        Data collection tools:&#xD;
  &#xD;
        Scoring the functional status of individuals' joints were evaluated by applying Western&#xD;
        Ontario and McMaster Universities Osteoarthritis Index (WOMAC)[2]. The WOMAC questionnaire&#xD;
        was published in the 1908s to assess osteoarthritis of hip and knee, which is a standard&#xD;
        criterion for assessing the health status of patients' self-reported activity. Three criteria&#xD;
        should be measured ranging between zero to 4 for each question, by the end of each evaluation&#xD;
        period: reduce pain is identified based on the mean for the first 5 WOMAC questions (from no&#xD;
        pain to severe pain), the 6th and 7th questions were specified for joint dryness (from no&#xD;
        dryness to severe limitation),and Joint movement is determined based on the average of&#xD;
        questions 0 to 24 (from no problem to severe limit).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 14, 2019</start_date>
    <completion_date type="Actual">February 12, 2020</completion_date>
    <primary_completion_date type="Actual">June 20, 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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Knee joint pain</measure>
      <time_frame>48 days</time_frame>
      <description>Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) .reduce pain is identified based on the mean for the first 5 WOMAC questions (from no pain to severe pain)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>joint movement limitation</measure>
      <time_frame>48 days</time_frame>
      <description>Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Joint movement is determined based on the average of questions 0 to 24 (from no problem to severe limit).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>joint dryness</measure>
      <time_frame>48 days</time_frame>
      <description>Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). the 6th and 7th questions were specified for joint dryness (from no dryness to severe limitation)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">110</enrollment>
    <condition>Osteo Arthritis Knee</condition>
    <arm_group>
      <arm_group_label>Black seed</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Black seed oil capsule taken orally</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo capsule taken orally</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Black seed oil capsule</intervention_name>
      <description>700 mg black seed soft gel capsule once a day from Gorgan Essential Oil Pharmaceutical Company,</description>
      <arm_group_label>Black seed</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo Black seed oil capsule</intervention_name>
      <description>Placebo Black seed oil capsule</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  unilateral or bilateral involvement of one or more joints for over 4 months,&#xD;
  &#xD;
            -  ability to walk&#xD;
  &#xD;
            -  ability to stay throughout the study period&#xD;
  &#xD;
            -  no history of underlying inflammatory disease (arthropathy / rheumatoid arthritis),&#xD;
  &#xD;
            -  absence of diabetes,&#xD;
  &#xD;
            -  no history of allergy to black seed&#xD;
  &#xD;
            -  absence of hyperuricemia (&lt;338 umol/l) or history of gout,&#xD;
  &#xD;
            -  absence of recent injury and trauma to the joint with osteoarthritis,&#xD;
  &#xD;
            -  absence of intra articular injection of corticosteroids in the last 4 months,&#xD;
  &#xD;
            -  lack of sensitivity to NSAIDS,&#xD;
  &#xD;
            -  no underlying liver and kidney disease or history of peptic ulcer Or gastrointestinal&#xD;
               bleeding, Congestive Heart Failure, hypertension, and hyperkalemia ,&#xD;
  &#xD;
            -  no fever&#xD;
  &#xD;
            -  absence of obvious Complete Blood Count disorders, coagulopathy, hematologic or&#xD;
               neurological disorders ,&#xD;
  &#xD;
            -  no alcohol consumption&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy,&#xD;
  &#xD;
            -  breast feeding,&#xD;
  &#xD;
            -  pregnancy-related decision&#xD;
  &#xD;
            -  obesity (BMI&gt; 30 kg /m2).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ramsar international campus</name>
        <address>
          <city>Ramsar</city>
          <state>Mazandaran</state>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ramsar international campus</investigator_affiliation>
      <investigator_full_name>Mohammad Khodashenas Roudsari</investigator_full_name>
      <investigator_title>Mohammad khodashenas roudsari ,Assistant prof of internal medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029868
  org study id: IR.BUMS. REC.1398.020
  nct id: NCT06029868
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Osteoarthritis is a continual illness of joints. We aim to investigate the effect of Nigella
        sativa oil in comparison with placebo on the reduction of osteoarthritis pain.
  
        This study is a double-blinded, randomized, controlled trial study, conducting in Vali-e-Asr
        Hospital in 2019, in Birjand, on patients with mild osteoarthritis. The Western Ontario and
        McMaster Universities Osteoarthritis Index is applied to score the functional status of
        participants' joints.
  This study was a randomized controlled trial. Regarding to the inclusion criteria, 110
        osteoarthritis patients were included in this study based on clinical signs, physical
        examination and radiological signs. In the next step, a fully explanation was given to the
        participants around the conditions of conducting the research, and then the informed consent
        were collected. Subsequently, patients were randomly divided into two groups of recipients;
        black seed soft gel capsules (intervention) and placebo equally in accordance with
        demographic information. Furthermore, the two groups were randomly classified regarding to
        age, consequently the study population was divided into subgroups of categorized ages.
        Thereafter, an equal number of each subgroup was randomly selected and divided into two
        groups to take black seed and placebo. Therefore, the two groups were similar, but the exact
        membership of individuals in the groups were random. Due to the higher prevalence of
        osteoarthritis among women in the community, the number of female cases were higher. It
        should be noted that the experimenters as well as patients did not know who was receiving a
        particular treatment (Double-blinded study). Prior to commencing the study, participants were
        asked to take a regular 48-day course of anti-inflammatory therapy. The cases in the
        intervention group took 700 mg of black seed soft gel capsule once a day from Gorgan
        Essential Oil Pharmaceutical Company, and the control group were treated by placebo capsules
        in the same-color and shape of the drug, with a taste of rice bran. Moreover, questionnaires
        were filled to record demographic information of both groups including age, sex, history
        medication and diet. The condition of participants were evaluated twice before the treatment
        and 48 days after the onset of black seed. At the end of each period, joint pain scores, the
        range of activity, and the dryness of the joints of all patients were assessed, and their
        mean were measured.
  
        Data collection tools:
  
        Scoring the functional status of individuals' joints were evaluated by applying Western
        Ontario and McMaster Universities Osteoarthritis Index (WOMAC)[2]. The WOMAC questionnaire
        was published in the 1908s to assess osteoarthritis of hip and knee, which is a standard
        criterion for assessing the health status of patients' self-reported activity. Three criteria
        should be measured ranging between zero to 4 for each question, by the end of each evaluation
        period: reduce pain is identified based on the mean for the first 5 WOMAC questions (from no
        pain to severe pain), the 6th and 7th questions were specified for joint dryness (from no
        dryness to severe limitation),and Joint movement is determined based on the average of
        questions 0 to 24 (from no problem to severe limit).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Knee joint pain
  time frame: 48 days
  description: Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) .reduce pain is identified based on the mean for the first 5 WOMAC questions (from no pain to severe pain)
  measure: joint movement limitation
  time frame: 48 days
  description: Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Joint movement is determined based on the average of questions 0 to 24 (from no problem to severe limit).
  measure: joint dryness
  time frame: 48 days
  description: Scoring the functional status of individuals' joints were evaluated by applying Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). the 6th and 7th questions were specified for joint dryness (from no dryness to severe limitation)
  arm group label: Black seed
  arm group type: Experimental
  description: Black seed oil capsule taken orally
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo capsule taken orally
  intervention type: Dietary Supplement
  intervention name: Black seed oil capsule
  description: 700 mg black seed soft gel capsule once a day from Gorgan Essential Oil Pharmaceutical Company,
  arm group label: Black seed
  intervention type: Dietary Supplement
  intervention name: Placebo Black seed oil capsule
  description: Placebo Black seed oil capsule
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Iran, Islamic Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Ramsar international campus
  investigator full name: Mohammad Khodashenas Roudsari
  investigator title: Mohammad khodashenas roudsari ,Assistant prof of internal medicine
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: No