<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/NCT03300999</url>
  </required_header>
  <id_info>
    <org_study_id>5170302</org_study_id>
    <nct_id>NCT03300999</nct_id>
  </id_info>
  <brief_title>The Effects of Daily Ginger Tea Consumption in Reducing Discomfort During Menstruation</brief_title>
  <official_title>The Effects of Daily Ginger Tea Consumption in Reducing Discomfort During Menstruation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</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>
      The purpose of our graduate student research study is to observe the effect of drinking&#xD;
      ginger tea daily on period discomfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Day 1: Subjects will sign informed consent and will go over the introduction, purpose,&#xD;
           procedures, and compliance with student investigators. Subjects will then be given a&#xD;
           sample of ginger tea that will be used for the study and will be asked if they think&#xD;
           they can drink this daily for a month. They will also be asked if they have regular&#xD;
           menstrual cycles and agree to stop home remedies and stop taking pain medications or&#xD;
           herbal supplements for a period of three menstruation cycles.&#xD;
&#xD;
        -  Start/During the first menstruation cycle: Subjects will meet with student investigators&#xD;
           at a convenient location to the subject and will complete surveys and questionnaires.&#xD;
           Subjects will be given visual analog pain scales and symptom checklists that need to be&#xD;
           completed during their second menstruation cycle.&#xD;
&#xD;
        -  End of the first menstruation cycle - Start of the second menstruation cycle: Subjects&#xD;
           will not take ginger tea, avoid home remedies, and refrain from taking pain medications&#xD;
           or supplements.&#xD;
&#xD;
        -  Start of the second menstruation cycle - End of the second menstruation cycle: Subjects&#xD;
           will rate discomfort using the visual analog pain scales and symptom checklist during&#xD;
           menstruation. Subjects will meet with student investigators at a convenient location to&#xD;
           the subject and will complete surveys and questionnaires. Subjects will be given daily&#xD;
           logs, visual analog pain scales, symptom checklists, and supplies for the ginger tea.&#xD;
&#xD;
        -  End of the second menstruation cycle - Start of the third menstruation cycle: Subjects&#xD;
           will take ginger tea daily, avoid home remedies, refrain from taking pain medications&#xD;
           and supplements, and keep track of ginger tea intake by placing a check mark each day in&#xD;
           the daily log checklist.&#xD;
&#xD;
        -  Start of the third menstruation cycle - End of the third menstruation cycle: Subjects&#xD;
           will rate discomfort using the visual analog pains scales and symptom checklist during&#xD;
           menstruation.&#xD;
&#xD;
        -  After the third menstruation cycle ends: Subjects will meet with student investigators&#xD;
           at a location convenient to the subject to turn in daily logs, visual analog pain&#xD;
           scales, and symptom checklists.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2017</start_date>
  <completion_date type="Actual">April 2, 2018</completion_date>
  <primary_completion_date type="Actual">April 2, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Pain Scale</measure>
    <time_frame>Change between Day 1 of the Second Menstruation Cycle and Day 28 of the Second Menstruation Cycle. Cycle is 28 days.</time_frame>
    <description>• The Visual Analogue scale is a form of a Likert scale that gives the interviewee maximum freedom to estimate their pain intensity. The interviewee will mark a line along the 10-cm scale which they perceive corresponds best to their exact pain intensity every day for the duration of the study. A score of zero indicated no pain and a score of 10 indicated the most severe pain felt.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Pain Scale</measure>
    <time_frame>Change between Day 1 of the Third Menstruation Cycle and Day 28 of the Third Menstruation Cycle. Cycle is 28 days.</time_frame>
    <description>• The Visual Analogue scale is a form of a Likert scale that gives the interviewee maximum freedom to estimate their pain intensity. The interviewee will mark a line along the 10-cm scale which they perceive corresponds best to their exact pain intensity every day for the duration of the study. A score of zero indicated no pain and a score of 10 indicated the most severe pain felt.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-36 Quality of Life Survey</measure>
    <time_frame>On any day between Day 1 and Day 28 of the first menstruation cycle. Cycle is 28 days.</time_frame>
    <description>RAND developed this validated survey and it is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. This survey consists of eight scaled scores which are the weighted sums of the questions in each section. The sections include vitality, physical functioning, bodily pain, physical role functioning, general health perception, emotional role functioning, social role functioning, and mental health. Each scale is transformed into a 0-100 scale and the lower score indicates more disability while the higher represents less disability. It can take participants at least half an hour to complete and will be assessed over a one-month period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 Quality of Life Survey</measure>
    <time_frame>Day 28 of the second menstruation cycle. Cycle is 28 days.</time_frame>
    <description>RAND developed this validated survey and it is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. This survey consists of eight scaled scores which are the weighted sums of the questions in each section. The sections include vitality, physical functioning, bodily pain, physical role functioning, general health perception, emotional role functioning, social role functioning, and mental health. Each scale is transformed into a 0-100 scale and the lower score indicates more disability while the higher represents less disability. It can take participants at least half an hour to complete and will be assessed over a one-month period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 Quality of Life Survey</measure>
    <time_frame>Day 28 of the third menstruation cycle. Cycle is 28 days.</time_frame>
    <description>RAND developed this validated survey and it is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. This survey consists of eight scaled scores which are the weighted sums of the questions in each section. The sections include vitality, physical functioning, bodily pain, physical role functioning, general health perception, emotional role functioning, social role functioning, and mental health. Each scale is transformed into a 0-100 scale and the lower score indicates more disability while the higher represents less disability. It can take participants at least half an hour to complete and will be assessed over a one-month period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Discomfort</condition>
  <arm_group>
    <arm_group_label>Ginger Tea</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>End of the second menstruation cycle - Start of the third menstruation cycle: Subjects will take ginger tea daily, avoid home remedies, refrain from taking pain medications and supplements, and keep track of ginger tea intake by placing a check mark each day in the daily log checklist.&#xD;
Start of the third menstruation cycle - End of the third menstruation cycle: Subjects will drink ginger tea daily. Subjects will rate discomfort using the visual analog pain scales and the symptom checklist at the end of each day during menstruation.&#xD;
After the third menstruation cycle ends: Subjects will meet with student investigators at a location convenient to the subject to turn in daily logs, visual analog pain scales, and symptom checklists.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Ginger Tea</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>End of the first menstruation cycle - Start of the second menstruation cycle: Subjects will not take ginger tea, avoid home remedies, and refrain from taking pain medications or supplements.&#xD;
Start of the second menstruation cycle - End of the second menstruation cycle: Subjects will rate discomfort using the visual analog pain scales and symptom checklist during menstruation. Subjects will meet with student investigators at a convenient location to the subject and will complete surveys and questionnaires. Subjects will be given daily logs, visual analog pain scales, symptom checklists, and supplies for the ginger tea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>ginger tea</intervention_name>
    <description>1. Ginger tea - Swanson Organic: 100% Certified Organic Ginger Root Tea&#xD;
• Subjects will use one tea bag (contains two grams ginger root), mix with eight ounces of boiling water, steep for three minutes, and allow it to cool to room temperature before drinking. This will be done every day for one month before their third menstruation cycle and during their third menstruation cycle.</description>
    <arm_group_label>Ginger Tea</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. female within age range&#xD;
&#xD;
          2. regular menstrual cycles&#xD;
&#xD;
          3. experiencing period cramps&#xD;
&#xD;
          4. agrees to refrain from taking any pain medications, herbal supplements, or use home&#xD;
             remedies such as heating pads that are known to alleviate menstrual cramps during the&#xD;
             study period&#xD;
&#xD;
          5. after sampling the ginger tea, the subject must agree to drink ginger tea daily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. women who take oral contraceptives&#xD;
&#xD;
          2. work night shifts&#xD;
&#xD;
          3. allergic to ginger&#xD;
&#xD;
          4. lactating&#xD;
&#xD;
          5. female-related uterine problems such as fibroids and polycystic ovarian syndrome who&#xD;
             suffer from secondary dysmenorrhea&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female with regular menstrual cycles</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyndra Woosley, MS RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loma Linda University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loma Linda Health</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ginger tea</keyword>
  <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/NCT03300999
org study id: 5170302
nct id: NCT03300999
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of our graduate student research study is to observe the effect of drinking
      ginger tea daily on period discomfort.
-  Day 1: Subjects will sign informed consent and will go over the introduction, purpose,
           procedures, and compliance with student investigators. Subjects will then be given a
           sample of ginger tea that will be used for the study and will be asked if they think
           they can drink this daily for a month. They will also be asked if they have regular
           menstrual cycles and agree to stop home remedies and stop taking pain medications or
           herbal supplements for a period of three menstruation cycles.

        -  Start/During the first menstruation cycle: Subjects will meet with student investigators
           at a convenient location to the subject and will complete surveys and questionnaires.
           Subjects will be given visual analog pain scales and symptom checklists that need to be
           completed during their second menstruation cycle.

        -  End of the first menstruation cycle - Start of the second menstruation cycle: Subjects
           will not take ginger tea, avoid home remedies, and refrain from taking pain medications
           or supplements.

        -  Start of the second menstruation cycle - End of the second menstruation cycle: Subjects
           will rate discomfort using the visual analog pain scales and symptom checklist during
           menstruation. Subjects will meet with student investigators at a convenient location to
           the subject and will complete surveys and questionnaires. Subjects will be given daily
           logs, visual analog pain scales, symptom checklists, and supplies for the ginger tea.

        -  End of the second menstruation cycle - Start of the third menstruation cycle: Subjects
           will take ginger tea daily, avoid home remedies, refrain from taking pain medications
           and supplements, and keep track of ginger tea intake by placing a check mark each day in
           the daily log checklist.

        -  Start of the third menstruation cycle - End of the third menstruation cycle: Subjects
           will rate discomfort using the visual analog pains scales and symptom checklist during
           menstruation.

        -  After the third menstruation cycle ends: Subjects will meet with student investigators
           at a location convenient to the subject to turn in daily logs, visual analog pain
           scales, and symptom checklists.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Visual Analog Pain Scale
time frame: Change between Day 1 of the Second Menstruation Cycle and Day 28 of the Second Menstruation Cycle. Cycle is 28 days.
description: • The Visual Analogue scale is a form of a Likert scale that gives the interviewee maximum freedom to estimate their pain intensity. The interviewee will mark a line along the 10-cm scale which they perceive corresponds best to their exact pain intensity every day for the duration of the study. A score of zero indicated no pain and a score of 10 indicated the most severe pain felt.
measure: Visual Analog Pain Scale
time frame: Change between Day 1 of the Third Menstruation Cycle and Day 28 of the Third Menstruation Cycle. Cycle is 28 days.
description: • The Visual Analogue scale is a form of a Likert scale that gives the interviewee maximum freedom to estimate their pain intensity. The interviewee will mark a line along the 10-cm scale which they perceive corresponds best to their exact pain intensity every day for the duration of the study. A score of zero indicated no pain and a score of 10 indicated the most severe pain felt.
measure: SF-36 Quality of Life Survey
time frame: On any day between Day 1 and Day 28 of the first menstruation cycle. Cycle is 28 days.
description: RAND developed this validated survey and it is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. This survey consists of eight scaled scores which are the weighted sums of the questions in each section. The sections include vitality, physical functioning, bodily pain, physical role functioning, general health perception, emotional role functioning, social role functioning, and mental health. Each scale is transformed into a 0-100 scale and the lower score indicates more disability while the higher represents less disability. It can take participants at least half an hour to complete and will be assessed over a one-month period.
measure: SF-36 Quality of Life Survey
time frame: Day 28 of the second menstruation cycle. Cycle is 28 days.
description: RAND developed this validated survey and it is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. This survey consists of eight scaled scores which are the weighted sums of the questions in each section. The sections include vitality, physical functioning, bodily pain, physical role functioning, general health perception, emotional role functioning, social role functioning, and mental health. Each scale is transformed into a 0-100 scale and the lower score indicates more disability while the higher represents less disability. It can take participants at least half an hour to complete and will be assessed over a one-month period.
measure: SF-36 Quality of Life Survey
time frame: Day 28 of the third menstruation cycle. Cycle is 28 days.
description: RAND developed this validated survey and it is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. This survey consists of eight scaled scores which are the weighted sums of the questions in each section. The sections include vitality, physical functioning, bodily pain, physical role functioning, general health perception, emotional role functioning, social role functioning, and mental health. Each scale is transformed into a 0-100 scale and the lower score indicates more disability while the higher represents less disability. It can take participants at least half an hour to complete and will be assessed over a one-month period.
arm group label: Ginger Tea
arm group type: Experimental
description: End of the second menstruation cycle - Start of the third menstruation cycle: Subjects will take ginger tea daily, avoid home remedies, refrain from taking pain medications and supplements, and keep track of ginger tea intake by placing a check mark each day in the daily log checklist.
Start of the third menstruation cycle - End of the third menstruation cycle: Subjects will drink ginger tea daily. Subjects will rate discomfort using the visual analog pain scales and the symptom checklist at the end of each day during menstruation.
After the third menstruation cycle ends: Subjects will meet with student investigators at a location convenient to the subject to turn in daily logs, visual analog pain scales, and symptom checklists.
arm group label: No Ginger Tea
arm group type: No Intervention
description: End of the first menstruation cycle - Start of the second menstruation cycle: Subjects will not take ginger tea, avoid home remedies, and refrain from taking pain medications or supplements.
Start of the second menstruation cycle - End of the second menstruation cycle: Subjects will rate discomfort using the visual analog pain scales and symptom checklist during menstruation. Subjects will meet with student investigators at a convenient location to the subject and will complete surveys and questionnaires. Subjects will be given daily logs, visual analog pain scales, symptom checklists, and supplies for the ginger tea.
intervention type: Dietary Supplement
intervention name: ginger tea
description: 1. Ginger tea - Swanson Organic: 100% Certified Organic Ginger Root Tea
• Subjects will use one tea bag (contains two grams ginger root), mix with eight ounces of boiling water, steep for three minutes, and allow it to cool to room temperature before drinking. This will be done every day for one month before their third menstruation cycle and during their third menstruation cycle.
arm group label: Ginger Tea
criteria: 
gender: Female
gender based: Yes
gender description: Female with regular menstrual cycles
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kyndra Woosley, MS RD
role: Principal Investigator
affiliation: Loma Linda University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No