<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/NCT01682551</url>
  </required_header>
  <id_info>
    <org_study_id>NRICM-10101</org_study_id>
    <nct_id>NCT01682551</nct_id>
  </id_info>
  <brief_title>Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness</brief_title>
  <official_title>Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China Medical University Hospital</source>
  <brief_summary>
    <textblock>
      This trial is aimed to evaluate the effects of &quot;Wu Zhu Yu Tang&quot; on the prevention of Acute&#xD;
      Mountain Sickness(AMS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, double blind, placebo-controlled clinical trial. It aims to&#xD;
      demonstrate that (1) Chinese medicine prescription &quot;Wu Zhu Yu Tang&quot; can prevent Acute&#xD;
      Mountain Sickness(AMS) (2) &quot;Wu Zhu Yu Tang&quot; can prevent AMS especially for Yang-Xu body&#xD;
      constitution.&#xD;
&#xD;
      We will randomize 240 unacclimatized healthy adults. They will be randomized after&#xD;
      stratification of the Yang-Xu score and the AMS history to receive Chinese medicine during&#xD;
      one ascent and placebo during the other ascent. We will take them in Hehuan mountain for two&#xD;
      days hike (24 hours) and an overnight over 3,000m. One month before the study, the subjects&#xD;
      will fill the &quot;Body Constitution Questionnaire BCQ&quot; in order to evaluate their body&#xD;
      constitution. Before, during and after the two days hike we will measure their blood&#xD;
      pressure, heart rate and arterial oxygen saturation. The incidence of AMS will be measured by&#xD;
      the Lake Louise Self Report (Lake Louise Score ≥4 with headache), we will also report the&#xD;
      Lake Louise Clinical Assessment score and Lake Louise Functional Score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2012</completion_date>
  <primary_completion_date type="Anticipated">September 2012</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache)</measure>
    <time_frame>The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS.</time_frame>
    <description>The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The Lake Louise score will measure before and after hiking.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Blood pressure will be measured before and after the hiking.</time_frame>
    <description>The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of blood pressure will be measured before and after hiking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Heart rate will be measured before and after the hiking.</time_frame>
    <description>The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of heart rate will be measured before and after hiking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial oxygen saturation</measure>
    <time_frame>Arterial oxygen saturation will be measured before and after the hiking.</time_frame>
    <description>Description:&#xD;
The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of arterial oxygen saturation will be measured before and after hiking.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Acute Mountain Sickness (AMS)</condition>
  <arm_group>
    <arm_group_label>Chinese Medicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participators in this arm will take 2g (powder in capsule) of &quot;Wu Zhu Yu Tang&quot; or placebo orally three times in the first day and one time in the second day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acetazolamide</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>If the participators have the history of AMS, he/she will be randomized to take &quot;Wu Zhu Yu Tang&quot; plus &quot;placebo of Acetalozamide&quot; or &quot;Acetalozamide&quot; plus &quot;placebo of Wu Zhu Yu Tang&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chinese Medicine</intervention_name>
    <description>The participators in this arm will take 2g (powder in capsule) of &quot;Wu Zhu Yu Tang&quot; or placebo orally three times in the first day and one time in the second day.</description>
    <arm_group_label>Acetazolamide</arm_group_label>
    <arm_group_label>Chinese Medicine</arm_group_label>
    <other_name>&quot;Wu Zhu Yu Tang&quot;</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetalozamide</intervention_name>
    <description>If the participators have the history of AMS, he/she will be randomized to take &quot;Wu Zhu Yu Tang&quot; plus &quot;placebo of Acetalozamide&quot; or &quot;Acetalozamide&quot; plus &quot;placebo of Wu Zhu Yu Tang&quot;.</description>
    <arm_group_label>Acetazolamide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic disease: cardiovascular disease, psychological disease, anemia, migraine.&#xD;
&#xD;
          -  long-term use of the following materials: Chinese herbs, steroid, antibiotics.&#xD;
&#xD;
          -  altitude acclimation: have been to mountain over 2000m in the past 1 month.&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of Chinese Medicine, China Medical University</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>September 13, 2012</last_update_submitted>
  <last_update_submitted_qc>September 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>High altitude illness</keyword>
  <keyword>Chinese medicine body constitution</keyword>
  <keyword>Chinese Medicine</keyword>
  <keyword>High altitude medicine</keyword>
  <keyword>Mountain trekking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Altitude Sickness</mesh_term>
  </condition_browse>
  <!-- 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/NCT01682551
org study id: NRICM-10101
nct id: NCT01682551
lead sponsor: 
collaborator: 
This trial is aimed to evaluate the effects of "Wu Zhu Yu Tang" on the prevention of Acute
      Mountain Sickness(AMS).
This study is a randomized, double blind, placebo-controlled clinical trial. It aims to
      demonstrate that (1) Chinese medicine prescription "Wu Zhu Yu Tang" can prevent Acute
      Mountain Sickness(AMS) (2) "Wu Zhu Yu Tang" can prevent AMS especially for Yang-Xu body
      constitution.

      We will randomize 240 unacclimatized healthy adults. They will be randomized after
      stratification of the Yang-Xu score and the AMS history to receive Chinese medicine during
      one ascent and placebo during the other ascent. We will take them in Hehuan mountain for two
      days hike (24 hours) and an overnight over 3,000m. One month before the study, the subjects
      will fill the "Body Constitution Questionnaire BCQ" in order to evaluate their body
      constitution. Before, during and after the two days hike we will measure their blood
      pressure, heart rate and arterial oxygen saturation. The incidence of AMS will be measured by
      the Lake Louise Self Report (Lake Louise Score ≥4 with headache), we will also report the
      Lake Louise Clinical Assessment score and Lake Louise Functional Score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache)
time frame: The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS.
description: The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The Lake Louise score will measure before and after hiking.
measure: Blood pressure
time frame: Blood pressure will be measured before and after the hiking.
description: The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of blood pressure will be measured before and after hiking.
measure: Heart rate
time frame: Heart rate will be measured before and after the hiking.
description: The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of heart rate will be measured before and after hiking.
measure: Arterial oxygen saturation
time frame: Arterial oxygen saturation will be measured before and after the hiking.
description: Description:
The investigators will take the participators in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. The change of arterial oxygen saturation will be measured before and after hiking.
arm group label: Chinese Medicine
arm group type: Experimental
description: The participators in this arm will take 2g (powder in capsule) of "Wu Zhu Yu Tang" or placebo orally three times in the first day and one time in the second day.
arm group label: Acetazolamide
arm group type: Placebo Comparator
description: If the participators have the history of AMS, he/she will be randomized to take "Wu Zhu Yu Tang" plus "placebo of Acetalozamide" or "Acetalozamide" plus "placebo of Wu Zhu Yu Tang".
intervention type: Drug
intervention name: Chinese Medicine
description: The participators in this arm will take 2g (powder in capsule) of "Wu Zhu Yu Tang" or placebo orally three times in the first day and one time in the second day.
arm group label: Acetazolamide
arm group label: Chinese Medicine
other name: "Wu Zhu Yu Tang"
intervention type: Drug
intervention name: Acetalozamide
description: If the participators have the history of AMS, he/she will be randomized to take "Wu Zhu Yu Tang" plus "placebo of Acetalozamide" or "Acetalozamide" plus "placebo of Wu Zhu Yu Tang".
arm group label: Acetazolamide
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Altitude Sickness