<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/NCT03778099</url>
  </required_header>
  <id_info>
    <org_study_id>W-001</org_study_id>
    <nct_id>NCT03778099</nct_id>
  </id_info>
  <brief_title>The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome</brief_title>
  <acronym>PCOS</acronym>
  <official_title>The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome, Jeddah 2019: Randomized Double-blind Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdulaziz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdulaziz University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Title: The effect of cinnamon supplementation on ovulation induction in women with polycystic&#xD;
      ovary syndrome, Jeddah 2019: Randomized Double-Blind Placebo-controlled trial&#xD;
&#xD;
      Phase: III&#xD;
&#xD;
      Population: 118 women with polycystic ovary syndrome will be recruited from Obstetrics and&#xD;
      Gynecology clinics in King Abdul-Aziz University Hospital, Jeddah 2019.&#xD;
&#xD;
      Subject Participation Duration: Each participant will be followed for three months.&#xD;
&#xD;
      Intervention: 2g of cinnamon capsules daily will be provided.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
        1. To compare the effectiveness of cinnamon supplement in combination with clomiphene&#xD;
           citrate versus clomiphene citrate alone on ovulation in women with PCOS, in King&#xD;
           Abdul-Aziz University Hospital in Jeddah 2019.&#xD;
&#xD;
        2. To measure the difference in insulin resistance after three months of cinnamon&#xD;
           supplementation in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.&#xD;
&#xD;
        3. To determine the effect of cinnamon and CC on menstrual cyclicity, approximated by&#xD;
           menstrual frequency, during the study period, in women with PCOS in King Abdul-Aziz&#xD;
           University Hospital, Jeddah 2019&#xD;
&#xD;
        4. To evaluate the quality of life in women with PCOS in King Abdul-Aziz University&#xD;
           Hospital, Jeddah 2019.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To measure the pregnancy rate in women with PCOS in King Abdul-Aziz University Hospital,&#xD;
           Jeddah 2019&#xD;
&#xD;
      Description of Study Design:&#xD;
&#xD;
      The participants will be randomized in 1:1 fashion. Allocation concealment will be ensured&#xD;
      using similar bottles labeled by letters A and B, to receive either the combination of&#xD;
      cinnamon supplement and clomiphene citrate or clomiphene citrate with placebo.&#xD;
&#xD;
      First visit: Patients will be evaluated during the early follicular phase for progesterone&#xD;
      level and HOMA-IR and QUICK-I. Follow up: 3 months.&#xD;
&#xD;
      Last Visit: Patients will be re-evaluated to compare the difference.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2018</start_date>
  <completion_date type="Actual">February 3, 2020</completion_date>
  <primary_completion_date type="Actual">January 10, 2020</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ovulation Confirmation by Progesterone level</measure>
    <time_frame>3 months</time_frame>
    <description>Progesterone level &gt; 3ng/mL or pregnancy confirmed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in insulin resistance</measure>
    <time_frame>3 months</time_frame>
    <description>HOMA-IR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Menstrual frequency</measure>
    <time_frame>3 months</time_frame>
    <description>No. of menses/ No. of months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life: Infertility quality of life questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>The 36 FertiQoL items are rated according to 5 types of response scales.&#xD;
The response scales are:&#xD;
Very poor (0), poor (1), neither poor nor good (2), very good (4) Very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4) Always (0), very often (1), quite often (2), Seldom (3), never (4) An extreme amount (0), very much (1), a moderate amount (2), a little (3), not at all (4) Completely (0), a great deal (1), moderately (2), not much (3), not at all (4)&#xD;
Scores on the response scales are reversed, summed and scaled to range from 0 to 100. Higher scores on the subscales and total scores indicate better quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pregnancy Rate</measure>
    <time_frame>3 months</time_frame>
    <description>Number of pregnancies including live births, induced abortions, and fetal deaths / Number of women aged 18 - 40 years) × 1,000</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <condition>Ovulation</condition>
  <arm_group>
    <arm_group_label>Cinnamon Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two capsules of cinnamon 500mg twice per day after meals (2g/day). All capsules will be given simultaneously with the clomiphene citrate medication (standard treatment for infertility in women with PCOS). Participants will be asked to keep their normal lifestyle including daily food and physical activity level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules will contain 450 mg of starch and 50 mg of cinnamon powder (to improve blindness regarding taste and odor). Color, shape, and size of placebo capsules will be exactly the same as the cinnamon capsules.&#xD;
2g/day along with clomiphene citrate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cinnamon Cap 500 MG</intervention_name>
    <description>The Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator.</description>
    <arm_group_label>Cinnamon Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>450 mg of starch and 50 mg of cinnamon powder</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Married women aged 18-40 seeking to become pregnant, meeting the Rotterdam criteria&#xD;
             for polycystic ovary syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current pregnancy or lactation.&#xD;
&#xD;
          -  Current use of treatment of infertility.&#xD;
&#xD;
          -  Established diagnosis of diabetes mellitus.&#xD;
&#xD;
          -  Use of Insulin-sensitizing treatment within the past three months.&#xD;
&#xD;
          -  Hormonal treatment involving estrogen or progesterone within the past three months.&#xD;
&#xD;
          -  Known hypersensitivity to cinnamon.&#xD;
&#xD;
          -  Use of statin medication.&#xD;
&#xD;
          -  Any other supplements that contain cinnamon within the past month.&#xD;
&#xD;
          -  BMI &lt;18.5 or BMI &gt;35.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women with PCOS</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wael H Alzhrani</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>King Abdulaziz University</name>
      <address>
        <city>Jeddah</city>
        <zip>21589</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 1, 2020</last_update_submitted>
  <last_update_submitted_qc>March 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdulaziz University</investigator_affiliation>
    <investigator_full_name>Dr. Wael Alzhrani</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>PCOS</keyword>
  <keyword>Ovulation</keyword>
  <keyword>Cinnamon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03778099
org study id: W-001
nct id: NCT03778099
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Title: The effect of cinnamon supplementation on ovulation induction in women with polycystic
      ovary syndrome, Jeddah 2019: Randomized Double-Blind Placebo-controlled trial

      Phase: III

      Population: 118 women with polycystic ovary syndrome will be recruited from Obstetrics and
      Gynecology clinics in King Abdul-Aziz University Hospital, Jeddah 2019.

      Subject Participation Duration: Each participant will be followed for three months.

      Intervention: 2g of cinnamon capsules daily will be provided.

      Objectives:

      Primary Objective:

        1. To compare the effectiveness of cinnamon supplement in combination with clomiphene
           citrate versus clomiphene citrate alone on ovulation in women with PCOS, in King
           Abdul-Aziz University Hospital in Jeddah 2019.

        2. To measure the difference in insulin resistance after three months of cinnamon
           supplementation in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.

        3. To determine the effect of cinnamon and CC on menstrual cyclicity, approximated by
           menstrual frequency, during the study period, in women with PCOS in King Abdul-Aziz
           University Hospital, Jeddah 2019

        4. To evaluate the quality of life in women with PCOS in King Abdul-Aziz University
           Hospital, Jeddah 2019.

      Secondary Objectives:

        -  To measure the pregnancy rate in women with PCOS in King Abdul-Aziz University Hospital,
           Jeddah 2019

      Description of Study Design:

      The participants will be randomized in 1:1 fashion. Allocation concealment will be ensured
      using similar bottles labeled by letters A and B, to receive either the combination of
      cinnamon supplement and clomiphene citrate or clomiphene citrate with placebo.

      First visit: Patients will be evaluated during the early follicular phase for progesterone
      level and HOMA-IR and QUICK-I. Follow up: 3 months.

      Last Visit: Patients will be re-evaluated to compare the difference.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Ovulation Confirmation by Progesterone level
time frame: 3 months
description: Progesterone level > 3ng/mL or pregnancy confirmed
measure: Changes in insulin resistance
time frame: 3 months
description: HOMA-IR
measure: Menstrual frequency
time frame: 3 months
description: No. of menses/ No. of months
measure: Quality of life: Infertility quality of life questionnaire
time frame: 6 months
description: The 36 FertiQoL items are rated according to 5 types of response scales.
The response scales are:
Very poor (0), poor (1), neither poor nor good (2), very good (4) Very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4) Always (0), very often (1), quite often (2), Seldom (3), never (4) An extreme amount (0), very much (1), a moderate amount (2), a little (3), not at all (4) Completely (0), a great deal (1), moderately (2), not much (3), not at all (4)
Scores on the response scales are reversed, summed and scaled to range from 0 to 100. Higher scores on the subscales and total scores indicate better quality of life.
measure: Pregnancy Rate
time frame: 3 months
description: Number of pregnancies including live births, induced abortions, and fetal deaths / Number of women aged 18 - 40 years) × 1,000
arm group label: Cinnamon Group
arm group type: Experimental
description: Two capsules of cinnamon 500mg twice per day after meals (2g/day). All capsules will be given simultaneously with the clomiphene citrate medication (standard treatment for infertility in women with PCOS). Participants will be asked to keep their normal lifestyle including daily food and physical activity level.
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Placebo capsules will contain 450 mg of starch and 50 mg of cinnamon powder (to improve blindness regarding taste and odor). Color, shape, and size of placebo capsules will be exactly the same as the cinnamon capsules.
2g/day along with clomiphene citrate
intervention type: Drug
intervention name: Cinnamon Cap 500 MG
description: The Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator.
arm group label: Cinnamon Group
intervention type: Drug
intervention name: Placebo
description: 450 mg of starch and 50 mg of cinnamon powder
arm group label: Placebo Group
criteria: 
gender: Female
gender based: Yes
gender description: Women with PCOS
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Wael H Alzhrani
role: Principal Investigator
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Abdulaziz University
investigator full name: Dr. Wael Alzhrani
investigator title: Principle Investigator
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
sharing ipd: Undecided