<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/NCT03270787</url>
  </required_header>
  <id_info>
    <org_study_id>TCM1421</org_study_id>
    <nct_id>NCT03270787</nct_id>
  </id_info>
  <brief_title>Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness</brief_title>
  <official_title>A Randomized, Double Blind, Placebo-controlled Study of Compound Danshen Dripping Pills in Preventing and Treating Acute Mountain Sickness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tasly Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tasly Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the efficacy and safety of compound danshen dripping pills in&#xD;
      preventing and treating acute mountain sickness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compound danshen dripping pills is mainly used for the treatment and prevention of coronary&#xD;
      heart disease and high-risk groups ,consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi&#xD;
      (Radix Notoginseng) and borneol.Danshen is the main drug efficacy of stasis, nourishing the&#xD;
      nerves.Pharmacological studies have shown that Danshen can improve the oxygen carrying&#xD;
      capacity of blood, increase oxygen supply to vital organs, effectively reduce hypoxia-induced&#xD;
      heart and other vital organs, brain and kidney damage. Danshen can activate the fibrinolytic&#xD;
      system, reduce blood viscosity, clear the microcirculation, promote blood circulation,&#xD;
      increasing the amount of tissue oxygen by inhibiting platelet aggregation.This study is being&#xD;
      conducted to evaluate the efficacy and safety of compound danshen dripping pills in&#xD;
      preventing and treating acute mountain sickness, when compared with placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 24, 2016</start_date>
  <completion_date type="Actual">July 13, 2017</completion_date>
  <primary_completion_date type="Actual">July 13, 2016</primary_completion_date>
  <phase>Phase 1/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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo</measure>
    <time_frame>7days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Acute Mountain Sickness</condition>
  <arm_group>
    <arm_group_label>Placebo Comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Comparator: controlled group Placebo,10pills,tid,po</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Compound danshen dripping pills</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Compound danshen dripping pills Compound danshen dripping pills ,10pills,tid,po</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Drug: Placebo Placebo,10pills,tid,treat 1 weeks.</description>
    <arm_group_label>Placebo Comparator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Compound danshen dripping pills</intervention_name>
    <description>Drug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks.</description>
    <arm_group_label>Compound danshen dripping pills</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18-45 years，Male or female, plain natives&#xD;
&#xD;
          -  first stationed at high altitude above 3,000 meters&#xD;
&#xD;
          -  Upon physical examination before enrollment in good health&#xD;
&#xD;
          -  BMI 19 to 24; (weight kg / height Sqm )&#xD;
&#xD;
          -  voluntary signs the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  menstruation, pregnancy and breast-feeding women&#xD;
&#xD;
          -  smoking, alcohol and drug abusers&#xD;
&#xD;
          -  Clear history of drug allergy or allergic persons&#xD;
&#xD;
          -  application of various drugs (including traditional Chinese medicine) two weeks ago&#xD;
&#xD;
          -  Combined with severe liver and kidney dysfunction (cardiac function Grade ≥3, liver&#xD;
             function Grade &gt; 2 times of the upper limit of normal, Cr&gt; upper limit of normal);&#xD;
&#xD;
          -  Subject with blood donation experiences or blood test experiences within three months&#xD;
             before be selected.&#xD;
&#xD;
          -  C- reactive protein test results exceed the upper limit of normal.&#xD;
&#xD;
          -  clinically significant gastrointestinal disease, mental illness and diabetes,&#xD;
             hyperthyroidism and other metabolic diseases;&#xD;
&#xD;
          -  Past suffering from cardiovascular and cerebrovascular disease&#xD;
&#xD;
          -  fatigue syndrome that is not by high altitude-induced&#xD;
&#xD;
          -  primary headache&#xD;
&#xD;
          -  Vomiting due to other causes, such as digestive disorders as a result of the vomiting&#xD;
             reflex, vomiting vestibular disorders, neurotic vomiting;&#xD;
&#xD;
          -  Allergies&#xD;
&#xD;
          -  Who participated in clinical trials of other drugs within a month&#xD;
&#xD;
          -  blood circulation, increase immunity and antioxidant drug users&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Zhao, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Tasly Group, Co. Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>People's Hospital of Tibet Autonomous Region</name>
      <address>
        <city>Damxung</city>
        <state>Tibet</state>
        <zip>850000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 23, 2016</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Mountain sickness</keyword>
  <keyword>Compound Danshen Dripping Pills</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Altitude Sickness</mesh_term>
  </condition_browse>
  <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/NCT03270787
org study id: TCM1421
nct id: NCT03270787
lead sponsor: 
has dmc: Yes
This study is to evaluate the efficacy and safety of compound danshen dripping pills in
      preventing and treating acute mountain sickness.
Compound danshen dripping pills is mainly used for the treatment and prevention of coronary
      heart disease and high-risk groups ,consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi
      (Radix Notoginseng) and borneol.Danshen is the main drug efficacy of stasis, nourishing the
      nerves.Pharmacological studies have shown that Danshen can improve the oxygen carrying
      capacity of blood, increase oxygen supply to vital organs, effectively reduce hypoxia-induced
      heart and other vital organs, brain and kidney damage. Danshen can activate the fibrinolytic
      system, reduce blood viscosity, clear the microcirculation, promote blood circulation,
      increasing the amount of tissue oxygen by inhibiting platelet aggregation.This study is being
      conducted to evaluate the efficacy and safety of compound danshen dripping pills in
      preventing and treating acute mountain sickness, when compared with placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo
time frame: 7days
arm group label: Placebo Comparator
arm group type: Placebo Comparator
description: Placebo Comparator: controlled group Placebo,10pills,tid,po
arm group label: Compound danshen dripping pills
arm group type: Experimental
description: Compound danshen dripping pills Compound danshen dripping pills ,10pills,tid,po
intervention type: Drug
intervention name: Placebo
description: Drug: Placebo Placebo,10pills,tid,treat 1 weeks.
arm group label: Placebo Comparator
intervention type: Drug
intervention name: Compound danshen dripping pills
description: Drug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks.
arm group label: Compound danshen dripping pills
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Min Zhao, PhD
role: Study Director
affiliation: Tasly Group, Co. Ltd.
facility: 
country: China
responsible party type: Sponsor
mesh term: Altitude Sickness
sharing ipd: No