<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/NCT04484662</url>
  </required_header>
  <id_info>
    <org_study_id>202005078RIND</org_study_id>
    <nct_id>NCT04484662</nct_id>
  </id_info>
  <brief_title>Potted Mint Plants</brief_title>
  <acronym>PMP</acronym>
  <official_title>Effects of Potted Mint Plants on Indoor Air Quality and the Concentration of Bacterium and Fungus, and Evaluation of Cardiovascular Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      This study will recruit 60 subjects, in sum of 30 families. We will measure 2 indoor&#xD;
      environments (living room and bedroom) for All-in-one monitoring the indoor air quality, in&#xD;
      which collected culturable fungus and bacteria indoor to calculate colony forming unit (CFU).&#xD;
      We will apply Kore Technology (MS-200) (Electron Ionization time-of-flight mass spectrometry,&#xD;
      EI-TOF-MS) to measure the indoor volatile organic chemicals (VOCs) before intervention and&#xD;
      perform repeated measurements of VOCs and the concentration of phytoncides before&#xD;
      intervention and one week later after placing potted plants into indoor environments (living&#xD;
      room and bedroom).&#xD;
&#xD;
      In conclusion, this study aims to investigate the clinical utility of potted mint plants in&#xD;
      reducing indoor bacterial and fungal growth and indoor air pollution, and cardiovascular&#xD;
      benefits. Furthermore, the possible application of indoor potted mint plant in antiviral&#xD;
      influenza or pneumonia in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The contribution of air pollution is a very important public health issue for human health.&#xD;
      Indoor air quality may have more influence on human health than outdoor air pollution.&#xD;
      Previous studies indicate indoor air pollution which causes respiratory disease has been&#xD;
      associated with cardiovascular disease. Besides, some studies showed that indoor CO2&#xD;
      concentration was positively correlated with virus detection and bacterial concentration in&#xD;
      the air, and coagulase-negative staphylococci (CNS) was detected in many poorly ventilated&#xD;
      indoor environments. Mint can release chemical substance to inhibit viruses and bacteria.&#xD;
      Among the components, the menthol and terpineol induced vasodilation so as to reduce blood&#xD;
      pressure. For the pilot study we have finished the qualitative and quantitative research in&#xD;
      chemical components released by the mint.&#xD;
&#xD;
      Therefore, this study aims to evaluate the indoor air quality and the distribution of fungal&#xD;
      and bacterial concentration in the indoor environment, analyze the effect of potted mint&#xD;
      plants on indoor air quality, fungal and bacterial concentration, and explore the correlation&#xD;
      between the intervention of potted mint plants and cardiovascular health.&#xD;
&#xD;
      This study will recruit 60 subjects, in sum of 30 families. We will measure 2 indoor&#xD;
      environments (living room and bedroom) for All-in-one monitoring the indoor air quality, in&#xD;
      which collected culturable fungus and bacteria indoor to calculate colony forming unit (CFU).&#xD;
      We will apply Kore Technology (MS-200) (Electron Ionization time-of-flight mass spectrometry,&#xD;
      EI-TOF-MS) to measure the indoor volatile organic chemicals (VOCs) before intervention and&#xD;
      perform repeated measurements of VOCs and the concentration of phytoncides before&#xD;
      intervention and one week later after placing potted plants into indoor environments (living&#xD;
      room and bedroom).&#xD;
&#xD;
      Furthermore, we used matrix-assisted laser desorption ionization time of flight mass&#xD;
      spectrometry (MALDI-TOF-MS) to identify microbiology; simultaneously, we record the outdoor&#xD;
      environment and indoor ventilation. To assess subjects' cardiovascular health, we use&#xD;
      DynaPulse to evaluate their cardiovascular function, and make them equipped with Holter&#xD;
      electrocardiography (ECG) to continuously monitor the trend of heart rate variability (HRV)&#xD;
      before and after intervention.&#xD;
&#xD;
      In conclusion, this study aims to investigate the clinical utility of potted mint plants in&#xD;
      reducing indoor bacterial and fungal growth and indoor air pollution, and cardiovascular&#xD;
      benefits. Furthermore, the possible application of indoor potted mint plant in antiviral&#xD;
      influenza or pneumonia in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">November 9, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">November 12, 2020</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>This study will recruit 60 subjects, in sum of 30 families.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This study will recruit 60 subjects, in sum of 30 families.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improve Indoor Air Quality</measure>
    <time_frame>one week</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Potted Mint Plants Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>We will measure 2 indoor environments (living room and bedroom) for placing potted plants. We will analyze the effect of potted mint plants on indoor air quality, fungal and bacterial concentration, and explore the correlation between the intervention of potted mint plants and cardiovascular health.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Potted Mint Plants</intervention_name>
    <description>We will measure 2 indoor environments (living room and bedroom) for placing potted plants.</description>
    <arm_group_label>Potted Mint Plants Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  in the Department of Cardiology or inpatients at National Taiwan University Hospital&#xD;
&#xD;
          -  aged 20-80&#xD;
&#xD;
          -  live in the Greater Taipei area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The research subjects must agree to cooperate with the health assessment.&#xD;
&#xD;
          -  serious brain, heart disease and mental illness&#xD;
&#xD;
          -  uncomfortable reactions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Su ta chen, PI</last_name>
    <role>Principal Investigator</role>
    <affiliation>NTUH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <state>Chung-Shan</state>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>November 30, 2020</last_update_submitted>
  <last_update_submitted_qc>November 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Potted mint plants</keyword>
  <keyword>Indoor air quality</keyword>
  <keyword>Fungus</keyword>
  <keyword>Bacteria</keyword>
  <keyword>Cardiovascular health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT04484662
org study id: 202005078RIND
nct id: NCT04484662
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will recruit 60 subjects, in sum of 30 families. We will measure 2 indoor
      environments (living room and bedroom) for All-in-one monitoring the indoor air quality, in
      which collected culturable fungus and bacteria indoor to calculate colony forming unit (CFU).
      We will apply Kore Technology (MS-200) (Electron Ionization time-of-flight mass spectrometry,
      EI-TOF-MS) to measure the indoor volatile organic chemicals (VOCs) before intervention and
      perform repeated measurements of VOCs and the concentration of phytoncides before
      intervention and one week later after placing potted plants into indoor environments (living
      room and bedroom).

      In conclusion, this study aims to investigate the clinical utility of potted mint plants in
      reducing indoor bacterial and fungal growth and indoor air pollution, and cardiovascular
      benefits. Furthermore, the possible application of indoor potted mint plant in antiviral
      influenza or pneumonia in the future.
The contribution of air pollution is a very important public health issue for human health.
      Indoor air quality may have more influence on human health than outdoor air pollution.
      Previous studies indicate indoor air pollution which causes respiratory disease has been
      associated with cardiovascular disease. Besides, some studies showed that indoor CO2
      concentration was positively correlated with virus detection and bacterial concentration in
      the air, and coagulase-negative staphylococci (CNS) was detected in many poorly ventilated
      indoor environments. Mint can release chemical substance to inhibit viruses and bacteria.
      Among the components, the menthol and terpineol induced vasodilation so as to reduce blood
      pressure. For the pilot study we have finished the qualitative and quantitative research in
      chemical components released by the mint.

      Therefore, this study aims to evaluate the indoor air quality and the distribution of fungal
      and bacterial concentration in the indoor environment, analyze the effect of potted mint
      plants on indoor air quality, fungal and bacterial concentration, and explore the correlation
      between the intervention of potted mint plants and cardiovascular health.

      This study will recruit 60 subjects, in sum of 30 families. We will measure 2 indoor
      environments (living room and bedroom) for All-in-one monitoring the indoor air quality, in
      which collected culturable fungus and bacteria indoor to calculate colony forming unit (CFU).
      We will apply Kore Technology (MS-200) (Electron Ionization time-of-flight mass spectrometry,
      EI-TOF-MS) to measure the indoor volatile organic chemicals (VOCs) before intervention and
      perform repeated measurements of VOCs and the concentration of phytoncides before
      intervention and one week later after placing potted plants into indoor environments (living
      room and bedroom).

      Furthermore, we used matrix-assisted laser desorption ionization time of flight mass
      spectrometry (MALDI-TOF-MS) to identify microbiology; simultaneously, we record the outdoor
      environment and indoor ventilation. To assess subjects' cardiovascular health, we use
      DynaPulse to evaluate their cardiovascular function, and make them equipped with Holter
      electrocardiography (ECG) to continuously monitor the trend of heart rate variability (HRV)
      before and after intervention.

      In conclusion, this study aims to investigate the clinical utility of potted mint plants in
      reducing indoor bacterial and fungal growth and indoor air pollution, and cardiovascular
      benefits. Furthermore, the possible application of indoor potted mint plant in antiviral
      influenza or pneumonia in the future.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study will recruit 60 subjects, in sum of 30 families.
primary purpose: Health Services Research
masking: None (Open Label)
masking description: This study will recruit 60 subjects, in sum of 30 families.
measure: Improve Indoor Air Quality
time frame: one week
arm group label: Potted Mint Plants Intervention
arm group type: Other
description: We will measure 2 indoor environments (living room and bedroom) for placing potted plants. We will analyze the effect of potted mint plants on indoor air quality, fungal and bacterial concentration, and explore the correlation between the intervention of potted mint plants and cardiovascular health.
intervention type: Other
intervention name: Potted Mint Plants
description: We will measure 2 indoor environments (living room and bedroom) for placing potted plants.
arm group label: Potted Mint Plants Intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Su ta chen, PI
role: Principal Investigator
affiliation: NTUH
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: Undecided