<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/NCT04471298</url>
  </required_header>
  <id_info>
    <org_study_id>TSL-TCM-QSYQDW-I</org_study_id>
    <nct_id>NCT04471298</nct_id>
  </id_info>
  <brief_title>A Study of Qishenyiqi Dripping Pills in Healthy Participants</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study to Evaluate the Safety and Tolerability of Continuous Oral Treatment With Qishenyiqi Dripping Pills in Healthy Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tasly Pharmaceutical Group Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tasly Pharmaceutical Group Co., Ltd</source>
  <oversight_info>
    <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 evaluate the safety and tolerability of Qishenyiqi Dripping Pills in healthy&#xD;
      participants, following oral administration with multiple escalating dose of it.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Qishenyiqi dripping pills, which are made of Huangqi, Danshen, Sanqi, active ingredients of&#xD;
      Jiangxiang, have the efficacy of beneficial effects of qi and pulse, blood circulation and&#xD;
      pain relief.&#xD;
&#xD;
      This study is a randomized, double-blind, placebo-controlled, dose-escalation design study,&#xD;
      including three cohorts and 36 healthy participants. Within each cohort, participant will&#xD;
      receive Qishenyiqi dripping pills at the selected dose level by oral administration three&#xD;
      times a day for 28 consecutive days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Actual">January 11, 2021</completion_date>
  <primary_completion_date type="Actual">January 11, 2021</primary_completion_date>
  <phase>Phase 1</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>From screening (2 weeks in advance) till follow-up visit (up to 1week)</time_frame>
    <description>Observe all the adverse events of all participants administrated orally with Qishenyiqi dripping pills.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal vital signs index (body temperature)</measure>
    <time_frame>From screening (2 weeks in advance) till the end of trial period (Day 29)</time_frame>
    <description>To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal vital signs index (pulse rate)</measure>
    <time_frame>From screening (2 weeks in advance) till the end of trial period (Day 29)</time_frame>
    <description>To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal vital signs index (respiratory rate)</measure>
    <time_frame>From screening (2 weeks in advance) till the end of trial period (Day 29)</time_frame>
    <description>To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal vital signs index (blood pressure)</measure>
    <time_frame>From screening (2 weeks in advance) till the end of trial period (Day 29)</time_frame>
    <description>To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical examination</measure>
    <time_frame>screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29</time_frame>
    <description>The complete physical examinations will include an assessment of the general appearance, skin, cardiovascular, abdomen, head, and neck, lymph nodes, musculoskeletal and neurological systems.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal laboratory assessments (blood routine test)</measure>
    <time_frame>screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29</time_frame>
    <description>To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal laboratory assessments (blood biochemical test)</measure>
    <time_frame>screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29</time_frame>
    <description>To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal laboratory assessments (coagulation function test)</measure>
    <time_frame>screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29</time_frame>
    <description>To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal laboratory assessments (urinalysis routine test)</measure>
    <time_frame>screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29</time_frame>
    <description>To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal laboratory assessments (fecal routine test)</measure>
    <time_frame>screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29</time_frame>
    <description>To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal findings in 12-lead safety Electrocardiogram (ECG)</measure>
    <time_frame>screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29</time_frame>
    <description>To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Active dosage group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Qishenyiqi dripping pills, 3.12g, oral, three times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active dosage group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Qishenyiqi dripping pills, 4.68g, oral, three times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active dosage group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Qishenyiqi dripping pills, 6.24g, oral, three times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control dosage group 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Qishenyiqi dripping pills placebo, 3.12g, oral, three times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control dosage group 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Qishenyiqi dripping pills placebo, 4.68g, oral, three times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control dosage group 3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Qishenyiqi dripping pills placebo, 6.24g, oral, three times a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Qishenyiqi dripping pills, 6 bags</intervention_name>
    <description>28 consecutive days</description>
    <arm_group_label>Active dosage group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Qishenyiqi dripping pills, 9 bags</intervention_name>
    <description>28 consecutive days</description>
    <arm_group_label>Active dosage group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Qishenyiqi dripping pills, 12 bags</intervention_name>
    <description>28 consecutive days</description>
    <arm_group_label>Active dosage group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Qishenyiqi dripping pills placebo, 6 bags</intervention_name>
    <description>28 consecutive days</description>
    <arm_group_label>Control dosage group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Qishenyiqi dripping pills placebo, 9 bags</intervention_name>
    <description>28 consecutive days</description>
    <arm_group_label>Control dosage group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Qishenyiqi dripping pills placebo, 12 bags</intervention_name>
    <description>28 consecutive days</description>
    <arm_group_label>Control dosage group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers, male or female, aged 18-50 years (including the boundary value);&#xD;
&#xD;
          -  Participants weigh at least 50.0 kg in male and 45.0 kg in female with a body mass&#xD;
             index of all subjects between 19 and 26kg/m2 (including the boundary value);&#xD;
&#xD;
          -  Participants are willing to have no pregnancy program and take effective contraceptive&#xD;
             measures voluntarily since signing informed consent form to 3 months after the last&#xD;
             administration;&#xD;
&#xD;
          -  Participants are willing to sign Independent Ethics Committee (IEC)-approved informed&#xD;
             consent form and able to understand and comply with study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with allergic constitution or have a history of allergy to drug or food;&#xD;
&#xD;
          -  Participants with diseases or physiological conditions that may affect the study,&#xD;
             including but not limited to diseases of the nervous, mental, respiratory,&#xD;
             cardiovascular, digestive, blood and lymphatic, endocrine, musculoskeletal systems,&#xD;
             liver and kidney dysfunction;&#xD;
&#xD;
          -  Participants who have any clinically significant abnormalities in vital signs,&#xD;
             physical examination, electrocardiogram, chest radiograph, abdominal ultrasound and&#xD;
             laboratory examination;&#xD;
&#xD;
          -  Participants who have positive test for hepatitis B virus surface antigen (except&#xD;
             surface antibodies), hepatitis C virus antibody, human immunodeficiency virus antibody&#xD;
             and treponema pallidum antibody;&#xD;
&#xD;
          -  Women who are in the state of pregnancy or lactation;&#xD;
&#xD;
          -  Participants who have a history of drug abuse or a positive test result for drug abuse&#xD;
             at screening;&#xD;
&#xD;
          -  Participants who have smoked more than 5 cigarette per day or used a considerable&#xD;
             amount of nicotine-containing products within the previous 3 months, and could not&#xD;
             quit smoking during the experiment;&#xD;
&#xD;
          -  Participants who have been drinking more than 14 units of alcohol per week within the&#xD;
             previous 3 months (1 unit ≈285 mL beer with 3.5% alcohol or 25 mL spirits with 40%&#xD;
             alcohol or 85 mL wines with 12% alcohol), or positive test for alcohol, or could not&#xD;
             abstain from drinking during the trial;&#xD;
&#xD;
          -  Participants who have taken any prescription drugs (including prescription,&#xD;
             nonprescription, herbal medicine, dietary supplement such as vitamin product and&#xD;
             calcium tablet) within 4 weeks before administration of investigational drugs;&#xD;
&#xD;
          -  Participants who have difficulty in venous blood collection or history of fainting&#xD;
             blood or needles;&#xD;
&#xD;
          -  Participants who have participated in any drug clinical trial within 3 months and have&#xD;
             taken the experimental drug or plan to participate in other clinical trials during the&#xD;
             trial period;&#xD;
&#xD;
          -  Participants who have donated or lost blood ≥200 mL within 3 months or received blood&#xD;
             transfusion or used blood products, or have blood donation plan during the trial&#xD;
             period;&#xD;
&#xD;
          -  Judged by the investigator, participants have poor compliance or have other factors&#xD;
             such as clinical, social or family that should not be included in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Teaching Hospital of Tianjin University of TCM</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 13, 2021</last_update_submitted>
  <last_update_submitted_qc>July 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Qishenyiqi Dripping Pills</keyword>
  <!-- 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/NCT04471298
org study id: TSL-TCM-QSYQDW-I
nct id: NCT04471298
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the safety and tolerability of Qishenyiqi Dripping Pills in healthy
      participants, following oral administration with multiple escalating dose of it.
Qishenyiqi dripping pills, which are made of Huangqi, Danshen, Sanqi, active ingredients of
      Jiangxiang, have the efficacy of beneficial effects of qi and pulse, blood circulation and
      pain relief.

      This study is a randomized, double-blind, placebo-controlled, dose-escalation design study,
      including three cohorts and 36 healthy participants. Within each cohort, participant will
      receive Qishenyiqi dripping pills at the selected dose level by oral administration three
      times a day for 28 consecutive days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse events
time frame: From screening (2 weeks in advance) till follow-up visit (up to 1week)
description: Observe all the adverse events of all participants administrated orally with Qishenyiqi dripping pills.
measure: Number of participants with abnormal vital signs index (body temperature)
time frame: From screening (2 weeks in advance) till the end of trial period (Day 29)
description: To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
measure: Number of participants with abnormal vital signs index (pulse rate)
time frame: From screening (2 weeks in advance) till the end of trial period (Day 29)
description: To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
measure: Number of participants with abnormal vital signs index (respiratory rate)
time frame: From screening (2 weeks in advance) till the end of trial period (Day 29)
description: To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
measure: Number of participants with abnormal vital signs index (blood pressure)
time frame: From screening (2 weeks in advance) till the end of trial period (Day 29)
description: To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
measure: Physical examination
time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
description: The complete physical examinations will include an assessment of the general appearance, skin, cardiovascular, abdomen, head, and neck, lymph nodes, musculoskeletal and neurological systems.
measure: Number of participants with abnormal laboratory assessments (blood routine test)
time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
description: To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
measure: Number of participants with abnormal laboratory assessments (blood biochemical test)
time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
description: To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
measure: Number of participants with abnormal laboratory assessments (coagulation function test)
time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
description: To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
measure: Number of participants with abnormal laboratory assessments (urinalysis routine test)
time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
description: To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
measure: Number of participants with abnormal laboratory assessments (fecal routine test)
time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
description: To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
measure: Number of participants with abnormal findings in 12-lead safety Electrocardiogram (ECG)
time frame: screening (2 weeks in advance), Day 8, Day 15, Day 22, Day 29
description: To investigate the safety and tolerability of Qishenyiqi dripping pills following oral administration in healthy participants.
arm group label: Active dosage group 1
arm group type: Active Comparator
description: Qishenyiqi dripping pills, 3.12g, oral, three times a day
arm group label: Active dosage group 2
arm group type: Active Comparator
description: Qishenyiqi dripping pills, 4.68g, oral, three times a day
arm group label: Active dosage group 3
arm group type: Active Comparator
description: Qishenyiqi dripping pills, 6.24g, oral, three times a day
arm group label: Control dosage group 1
arm group type: Placebo Comparator
description: Qishenyiqi dripping pills placebo, 3.12g, oral, three times a day
arm group label: Control dosage group 2
arm group type: Placebo Comparator
description: Qishenyiqi dripping pills placebo, 4.68g, oral, three times a day
arm group label: Control dosage group 3
arm group type: Placebo Comparator
description: Qishenyiqi dripping pills placebo, 6.24g, oral, three times a day
intervention type: Drug
intervention name: Qishenyiqi dripping pills, 6 bags
description: 28 consecutive days
arm group label: Active dosage group 1
intervention type: Drug
intervention name: Qishenyiqi dripping pills, 9 bags
description: 28 consecutive days
arm group label: Active dosage group 2
intervention type: Drug
intervention name: Qishenyiqi dripping pills, 12 bags
description: 28 consecutive days
arm group label: Active dosage group 3
intervention type: Drug
intervention name: Qishenyiqi dripping pills placebo, 6 bags
description: 28 consecutive days
arm group label: Control dosage group 1
intervention type: Drug
intervention name: Qishenyiqi dripping pills placebo, 9 bags
description: 28 consecutive days
arm group label: Control dosage group 2
intervention type: Drug
intervention name: Qishenyiqi dripping pills placebo, 12 bags
description: 28 consecutive days
arm group label: Control dosage group 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor