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/NCT06018740</url>
    </required_header>
    <id_info>
      <org_study_id>20356</org_study_id>
      <nct_id>NCT06018740</nct_id>
    </id_info>
    <brief_title>A Study to Examine the Effects of a Daily Supplement on Common Symptoms of Perimenopause and Menopause</brief_title>
    <official_title>A Single Group Clinical Trial to Examine the Effects of a Daily Supplement on Common Symptoms of Perimenopause and Menopause</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hologram Sciences</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Citruslabs</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Hologram Sciences</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>
        Symptoms of perimenopause and menopause can significantly affect overall quality of life. It&#xD;
        is hypothesized that daily supplements can reduce the severity of these symptoms. This&#xD;
        12-week clinical trial will examine the effects of Hologram Sciences' Daily Balance Gummy&#xD;
        Supplements on symptoms including hot flashes, night sweats, mood swings, anxiety, fatigue,&#xD;
        and brain fog. Participants will take the product daily and complete study-specific&#xD;
        questionnaires at Baseline, Week 4, Week 8, and Week 12. Upon conclusion of Week 12,&#xD;
        participants will be asked to count how many gummies remain in their jar.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">November 13, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 6, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single group clinical trial.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Open Label</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in score on the Menopause Rating Scale (MRS). [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>The Menopause Rating Scale (MRS) is a commonly used assessment tool in medical and research settings to evaluate the severity and impact of menopausal symptoms on women's lives. 5 point Likert scale, with the following points relating to menopausal symptoms: 0 - None (absent)&#xD;
  - Mild (light)&#xD;
  - Moderate (medium)&#xD;
  - Severe (heavy)&#xD;
  - Very severe (very heavy)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in hot flashes. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Survey-based assessment (0-5 point scale) of changes in hot flashes. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as &quot;Not noticeable&quot; to &quot;severe.&quot; A score of 0 represents the least favorable/worse outcome ('Extremely often') and 5 representing the most beneficial response (i.e., &quot;never&quot;).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in night sweats. [Baseline to 12 Weeks]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Survey-based assessment (0-5 point scale) of changes in night sweats. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as &quot;Not noticeable&quot; to &quot;severe.&quot; A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., &quot;not noticeable&quot;).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in brain fog. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Survey-based assessment (0-5 point scale) of changes in brain fog. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as &quot;Not noticeable&quot; to &quot;severe.&quot; A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., &quot;not noticeable&quot;).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in mood swings. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Survey-based assessment (0-5 point scale) of changes in mood swings. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as &quot;Not noticeable&quot; to &quot;severe.&quot; A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., &quot;not noticeable&quot;).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in sleep disturbances. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Survey-based assessment (0-5 point scale) of changes in sleep disturbances. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as &quot;Not noticeable&quot; to &quot;severe.&quot; A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., &quot;not noticeable&quot;).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in fatigue. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Survey-based assessment (0-5 point scale) of changes in fatigue. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as &quot;Not noticeable&quot; to &quot;severe.&quot; A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., &quot;not noticeable&quot;).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in participant-reported quality of life. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Survey-based assessment (0-5 point scale) of quality of life. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as &quot;Not noticeable&quot; to &quot;severe.&quot; A score of 0 represents the least favorable/worse outcome ('Very Poor') and 5 represents the most beneficial response (i.e., &quot;Excellent&quot;).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Menopause</condition>
    <condition>Perimenopause</condition>
    <arm_group>
      <arm_group_label>Daily Balance Gummy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One Daily Balance Gummy should be taken with the last meal of the day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Daily Balance Gummy</intervention_name>
      <description>Phenology Daily Balance Gummies 30 ct. Yuzu Tangerine Flavor. Product contains Vitamin D2, Vitamin K2, Vitamin B6, Vitamin B12, Biotin, Genistein, Saffron Extract, Organic Tapioca Syrup, Organic Cane Sugar, Water, Pectin, Citric Acid, Natural Flavors.</description>
      <arm_group_label>Daily Balance Gummy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Women aged 40-65 years old Must be experiencing at least two symptoms of menopause, such as&#xD;
          sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function,&#xD;
          urinary changes, irregular or absent periods, or vaginal changes Must experience hot&#xD;
          flashes and/or night sweats at least 5 times per day Can be either natural or surgical&#xD;
          menopause (or perimenopause) Willing to adhere to the study protocol for the duration of&#xD;
          the study&#xD;
  &#xD;
          Willing to consult with their physician prior to starting the trial if taking any of the&#xD;
          following medications:&#xD;
  &#xD;
          Levothyroxine Liothyronine Calcipotriene (Dovonex) Digoxin (Lanoxin) Diltiazem (Cardizem)&#xD;
          Verapamil (Calan, others) Thiazide diuretics Atorvastatin (Lipitor) Warfarin - Might&#xD;
          increase the amount of time it takes for blood clotting. Minosalicylic acid (Paser)&#xD;
          Colchicine (Colcrys, Mitigare, Gloperba) Metformin (Glumetza, Fortamet, others) Proton pump&#xD;
          inhibitors (omeprazole (Prilosec), lansoprazole (Prevacid) or other stomach acid-reducing&#xD;
          drugs) Phenytoin (Dilantin) Antihypertensive drugs Phenobarbital (Luminal) Amiodarone&#xD;
          (Cordarone) Levodopa&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Not experiencing hot flashes and/or night sweats at least 5 times per day Has taken herbal&#xD;
          supplements or multivitamins within the last 1 month Current use of conventional hormone&#xD;
          replacement therapies, or plan to start during the study duration Current use of hormonal&#xD;
          birth control, or plan to start during the study duration Known allergies to any product&#xD;
          ingredients including the purified isoflavone genistein History of uterine fibroids,&#xD;
          endometriosis, polycystic ovarian syndrome, or history of abnormal pap smear Anyone with&#xD;
          any known severe allergies requiring the use of an epi-pen Unwilling to adhere to the study&#xD;
          protocol Anyone living with uncontrolled or chronic health disorders, including oncological&#xD;
          or psychiatric disorders No planned invasive medical procedures for the duration of the&#xD;
          study Pregnant or breastfeeding&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Citruslabs</name>
        <address>
          <city>Santa Monica</city>
          <state>California</state>
          <zip>90404</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06018740
  org study id: 20356
  nct id: NCT06018740
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Symptoms of perimenopause and menopause can significantly affect overall quality of life. It
        is hypothesized that daily supplements can reduce the severity of these symptoms. This
        12-week clinical trial will examine the effects of Hologram Sciences' Daily Balance Gummy
        Supplements on symptoms including hot flashes, night sweats, mood swings, anxiety, fatigue,
        and brain fog. Participants will take the product daily and complete study-specific
        questionnaires at Baseline, Week 4, Week 8, and Week 12. Upon conclusion of Week 12,
        participants will be asked to count how many gummies remain in their jar.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single group clinical trial.
  primary purpose: Other
  masking: None (Open Label)
  masking description: Open Label
  measure: Changes in score on the Menopause Rating Scale (MRS). [Baseline to Week 12]
  time frame: 12 weeks
  description: The Menopause Rating Scale (MRS) is a commonly used assessment tool in medical and research settings to evaluate the severity and impact of menopausal symptoms on women's lives. 5 point Likert scale, with the following points relating to menopausal symptoms: 0 - None (absent)
  - Mild (light)
  - Moderate (medium)
  - Severe (heavy)
  - Very severe (very heavy)
  measure: Change in hot flashes. [Baseline to Week 12]
  time frame: 12 weeks
  description: Survey-based assessment (0-5 point scale) of changes in hot flashes. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('Extremely often') and 5 representing the most beneficial response (i.e., "never").
  measure: Change in night sweats. [Baseline to 12 Weeks]
  time frame: 12 weeks
  description: Survey-based assessment (0-5 point scale) of changes in night sweats. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
  measure: Change in brain fog. [Baseline to Week 12]
  time frame: 12 weeks
  description: Survey-based assessment (0-5 point scale) of changes in brain fog. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
  measure: Change in mood swings. [Baseline to Week 12]
  time frame: 12 weeks
  description: Survey-based assessment (0-5 point scale) of changes in mood swings. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
  measure: Change in sleep disturbances. [Baseline to Week 12]
  time frame: 12 weeks
  description: Survey-based assessment (0-5 point scale) of changes in sleep disturbances. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
  measure: Change in fatigue. [Baseline to Week 12]
  time frame: 12 weeks
  description: Survey-based assessment (0-5 point scale) of changes in fatigue. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('severe') and 5 represents the most beneficial response (i.e., "not noticeable").
  measure: Changes in participant-reported quality of life. [Baseline to Week 12]
  time frame: 12 weeks
  description: Survey-based assessment (0-5 point scale) of quality of life. The survey has been designed specifically for use in this study and includes study-specific questions. Data will be collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." A score of 0 represents the least favorable/worse outcome ('Very Poor') and 5 represents the most beneficial response (i.e., "Excellent").
  arm group label: Daily Balance Gummy
  arm group type: Experimental
  description: One Daily Balance Gummy should be taken with the last meal of the day.
  intervention type: Dietary Supplement
  intervention name: Daily Balance Gummy
  description: Phenology Daily Balance Gummies 30 ct. Yuzu Tangerine Flavor. Product contains Vitamin D2, Vitamin K2, Vitamin B6, Vitamin B12, Biotin, Genistein, Saffron Extract, Organic Tapioca Syrup, Organic Cane Sugar, Water, Pectin, Citric Acid, Natural Flavors.
  arm group label: Daily Balance Gummy
  criteria: 
  gender: Female
  minimum age: 40 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Undecided