<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/NCT01686230</url>
  </required_header>
  <id_info>
    <org_study_id>2012CB518501-4</org_study_id>
    <nct_id>NCT01686230</nct_id>
  </id_info>
  <brief_title>Acupuncture in Patients With Stable Angina Pectoris</brief_title>
  <acronym>ASAP</acronym>
  <official_title>Effect of Acupuncture in Patients With Stable Angina Pectoris: an Open Label, Randomized, Controlled,Multi-center Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hunan University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chengdu University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trail aims to evaluate the efficacy of acupoints on the specific meridian for chronic&#xD;
      stable angina pectoris, compared with acupoints on the other meridian, sham acupoints and&#xD;
      waiting-list. And to confirm the specificity of acupoints on meridian.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The basis of acupuncture is the theory of meridians and acupoints. Meridian and collaterals&#xD;
      internally pertain to viscera, and externally spread over the extremities. An acupoint is the&#xD;
      place where the visceral qi and meridian qi distributed in. besides acupoints are the&#xD;
      stimulus points and reactive points for acupuncture to treat the diseases. Selecting the&#xD;
      acupoints on the specific meridian is the basic principle of acupuncture. Recently, as to the&#xD;
      existence of specificity of acupoints on the meridian has been questioned by many&#xD;
      researchers. This trial using chronic stable angina pectoris as a carrier, select the&#xD;
      acupoints on the hand shao yin heart meridian and hand jue yin pericardium meridian to treat&#xD;
      chronic stable angina pectoris. Compared with acupoints on the other meridian and&#xD;
      non-acupoints ,aiming to evaluate the efficacy, furthermore ,to confirm the existence of the&#xD;
      specificity of acupoints on meridian.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of angina attacks</measure>
    <time_frame>16 weeks after inclusion</time_frame>
    <description>The frequency of angina attack during 4-week.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The severity of angina ( VAS score)</measure>
    <time_frame>0 day,4, 8, 12, 16 weeks after inclusion</time_frame>
    <description>The VAS score evaluation angina pain severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The dosage of nitroglycerin</measure>
    <time_frame>0 day,4, 8, 12, 16 weeks after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six minute walk test</measure>
    <time_frame>0 day and 4 weeks after inclusion</time_frame>
    <description>Six minute walk test in the evaluation of exercise tolerance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic ECG Observation of the changes of ST-T</measure>
    <time_frame>0 day and 4 weeks after inclusion</time_frame>
    <description>Dynamic electrocardiogram in six minute walk test to do</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Seattle Angina Questionnaire ( SAQ ) score</measure>
    <time_frame>0 day,4, 8, 12, 16 weeks after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-rating anxiety scale</measure>
    <time_frame>0 day,4, 8, 16 weeks after inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of cardiovascular episode during the 4 months</measure>
    <time_frame>4, 8, 12, 16 weeks after inclusion</time_frame>
    <description>The incidence of cardiovascular episode during the 4 months(develop into unstable angina, acute myocardial infarction, death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rating Depression Scale</measure>
    <time_frame>0 day,4, 8, 16 weeks after inclusion</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">404</enrollment>
  <condition>Angina, Stable</condition>
  <arm_group>
    <arm_group_label>acupoints on specific meridian</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>acupoints on the other meridian</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham acupoints</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Acupuncture plus foundation treatment。We use sham acupoints。</description>
  </arm_group>
  <arm_group>
    <arm_group_label>waiting-list</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>wait for the treatment，Only basic treatment, We will not treat the participants until they complete all the observations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>In each session, we treat bilaterally, 3 times a week and 2 days off a week, each patient in the acupuncture treatment groups will receive 12 sessions of acupuncture treatment over 4 weeks. The whole study period is 20 weeks including 4-week baseline period,4-week treatment period, and 12-week follow-up period. we will investigate at 0 day,4week,8week,12week,16week after randomization。</description>
    <arm_group_label>acupoints on specific meridian</arm_group_label>
    <arm_group_label>acupoints on the other meridian</arm_group_label>
    <arm_group_label>sham acupoints</arm_group_label>
    <other_name>Electro-acupuncture，Massage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Basic treatment</intervention_name>
    <description>Each group in the basic treatment，Foundation treatment including health education and basic drug therapy.&#xD;
We recommend lifestyle modification for all patients. Modifications include increasing exercise; limiting alcohol consumption; and weight loss; quit smorking etc.&#xD;
Basic medication： Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.</description>
    <arm_group_label>acupoints on specific meridian</arm_group_label>
    <arm_group_label>acupoints on the other meridian</arm_group_label>
    <arm_group_label>sham acupoints</arm_group_label>
    <arm_group_label>waiting-list</arm_group_label>
    <other_name>health education ， basic drug therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.Meet the diagnostic criteria of ACC/AHA angina pectoris of coronary heart disease.&#xD;
&#xD;
        2.35 ≤ age ≤ 80 years of age, both male and female.&#xD;
&#xD;
        3.The onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week.&#xD;
&#xD;
        4.Patients signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age≤35 or age≥80&#xD;
&#xD;
          2. Pregnant women or women in lactation or women of child bearing potential plan to&#xD;
             conceive in the recent six months.&#xD;
&#xD;
          3. Combined with cardiovascular, digestive, respiratory, urinary, blood, nervous,&#xD;
             endocrine system, severe primary disease clinical failed to effectively control the&#xD;
             disease.&#xD;
&#xD;
          4. Complicated with mental disorders.&#xD;
&#xD;
          5. allergic constitution or bleeding disorder.&#xD;
&#xD;
          6. Patients accompany with acute coronary syndrome (including acute myocardial&#xD;
             infarction, unstable angina), severe arrhythmias ( severe atrioventricular block,&#xD;
             ventricular tachycardia, heartbeat influence the flow dynamics in supraventricular&#xD;
             tachycardia, heartbeat frequent premature beats especially premature ventricular&#xD;
             contractions ), atrial fibrillation, primary cardiomyopathy, valvular heart disease.&#xD;
&#xD;
          7. The blood pressure and blood glucose fail to meet the treatment targets.&#xD;
&#xD;
          8. Cardiovascular disease who had been treated with acupuncture during the previous three&#xD;
             months.&#xD;
&#xD;
          9. Currently participating in other clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>fan-rong liang, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Chengdu University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chengdu University of Traditional Chinese Medicine</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610075</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>Angina</keyword>
  <keyword>Stable Angina Pectoris</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Stable</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/NCT01686230
org study id: 2012CB518501-4
nct id: NCT01686230
lead sponsor: 
collaborator: 
has dmc: Yes
This trail aims to evaluate the efficacy of acupoints on the specific meridian for chronic
      stable angina pectoris, compared with acupoints on the other meridian, sham acupoints and
      waiting-list. And to confirm the specificity of acupoints on meridian.
The basis of acupuncture is the theory of meridians and acupoints. Meridian and collaterals
      internally pertain to viscera, and externally spread over the extremities. An acupoint is the
      place where the visceral qi and meridian qi distributed in. besides acupoints are the
      stimulus points and reactive points for acupuncture to treat the diseases. Selecting the
      acupoints on the specific meridian is the basic principle of acupuncture. Recently, as to the
      existence of specificity of acupoints on the meridian has been questioned by many
      researchers. This trial using chronic stable angina pectoris as a carrier, select the
      acupoints on the hand shao yin heart meridian and hand jue yin pericardium meridian to treat
      chronic stable angina pectoris. Compared with acupoints on the other meridian and
      non-acupoints ,aiming to evaluate the efficacy, furthermore ,to confirm the existence of the
      specificity of acupoints on meridian.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of angina attacks
time frame: 16 weeks after inclusion
description: The frequency of angina attack during 4-week.
measure: The severity of angina ( VAS score)
time frame: 0 day,4, 8, 12, 16 weeks after inclusion
description: The VAS score evaluation angina pain severity
measure: The dosage of nitroglycerin
time frame: 0 day,4, 8, 12, 16 weeks after inclusion
measure: Six minute walk test
time frame: 0 day and 4 weeks after inclusion
description: Six minute walk test in the evaluation of exercise tolerance
measure: Dynamic ECG Observation of the changes of ST-T
time frame: 0 day and 4 weeks after inclusion
description: Dynamic electrocardiogram in six minute walk test to do
measure: The Seattle Angina Questionnaire ( SAQ ) score
time frame: 0 day,4, 8, 12, 16 weeks after inclusion
measure: self-rating anxiety scale
time frame: 0 day,4, 8, 16 weeks after inclusion
measure: The incidence of cardiovascular episode during the 4 months
time frame: 4, 8, 12, 16 weeks after inclusion
description: The incidence of cardiovascular episode during the 4 months(develop into unstable angina, acute myocardial infarction, death)
measure: Self-rating Depression Scale
time frame: 0 day,4, 8, 16 weeks after inclusion
arm group label: acupoints on specific meridian
arm group type: Experimental
description: Acupuncture plus foundation treatment。 We Select specific acpupoints on the heart and pericardium meridian.
arm group label: acupoints on the other meridian
arm group type: Active Comparator
description: Acupuncture plus foundation treatment。We choose the acupoints on the other meridian。
arm group label: sham acupoints
arm group type: Sham Comparator
description: Acupuncture plus foundation treatment。We use sham acupoints。
arm group label: waiting-list
arm group type: Other
description: wait for the treatment，Only basic treatment, We will not treat the participants until they complete all the observations.
intervention type: Other
intervention name: acupuncture
description: In each session, we treat bilaterally, 3 times a week and 2 days off a week, each patient in the acupuncture treatment groups will receive 12 sessions of acupuncture treatment over 4 weeks. The whole study period is 20 weeks including 4-week baseline period,4-week treatment period, and 12-week follow-up period. we will investigate at 0 day,4week,8week,12week,16week after randomization。
arm group label: acupoints on specific meridian
arm group label: acupoints on the other meridian
arm group label: sham acupoints
other name: Electro-acupuncture，Massage
intervention type: Drug
intervention name: Basic treatment
description: Each group in the basic treatment，Foundation treatment including health education and basic drug therapy.
We recommend lifestyle modification for all patients. Modifications include increasing exercise; limiting alcohol consumption; and weight loss; quit smorking etc.
Basic medication： Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
arm group label: acupoints on specific meridian
arm group label: acupoints on the other meridian
arm group label: sham acupoints
arm group label: waiting-list
other name: health education ， basic drug therapy
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: fan-rong liang, Professor
role: Study Chair
affiliation: Chengdu University of Traditional Chinese Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Angina Pectoris
mesh term: Angina, Stable