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The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris

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ClinicalTrials.gov Identifier: NCT03975140
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Xin, West China Hospital

Brief Summary:
The investigators used a double-blind single-center randomized controlled trial to explore the prevention value of acupoint sensitization based on stable angina pectoris, so as to verify the hypothesis that "acupoint sensitization by finger pressing in traditional Chinese medicine can alleviate the onset of stable angina pectoris".After the inclusion of eligible patients, the patients were randomly assigned to test their acupoint sensitization value. The first five acupoints in the sensitization sequence were pressed on patients in the experimental group, and the last five acupoints were pressed on patients in the control group.The patients received treatment every other day for a total of 3 times a week for 4 weeks, followed up for 4 weeks after the end of treatment.Patients were evaluated three times at baseline, at the end of treatment, and 4 weeks after the end of treatment, to assess angina episodes during the each period, as well as indicators such as the Canadian society of cardiology (CCS) angina classification.

Condition or disease Intervention/treatment Phase
The Clinical Value of Acupoint Sensitization Procedure: Hypersensitive acupoint group Procedure: Hyposensitive acupoint group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: Hypersensitive acupoint group Procedure: Hypersensitive acupoint group
The first five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes.

Active Comparator: Hyposensitive acupoint group Procedure: Hyposensitive acupoint group
The last five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes.




Primary Outcome Measures :
  1. Change of the number of angina attacks [ Time Frame: Change from baseline to week 8 ]
    Change of the number of uncomfortable events that met the criteria for angina in study period


Secondary Outcome Measures :
  1. Change of the Canadian Cardiology Society (CCS) Classification of Angina Pectoris [ Time Frame: Change from baseline to week 8 ]
    According to the patient's own condition scale, the patients were divided into 4 grades, the mildest being grade I and the most serious being grade IV

  2. Change of the Seattle Angina Questionnaire(SAQ) Score [ Time Frame: Change from baseline to week 8 ]
    The maximum score of the scale was 100, and the higher the score, the better the quality of life and the functional state of the patients

  3. Change of the use of Therapeutic Nitroglycerin Drugs [ Time Frame: Change from baseline to week 8 ]
    Change of the number of times that patients temporarily took nitroglycerin for angina attacks



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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with stable angina pectoris and symptoms of chest pain
  • The duration of onset was more than 3 months, and the frequency of onset per week in the past month was more than or equal to 2
  • Not younger than 35 years old and not older than 80 years old
  • Patients will participate in the study voluntarily and have signed the informed consent

Exclusion Criteria:

  • Patients with mental retardation
  • Patients were contraindicated or unable to complete acupoint sensitization test
  • Patients with cardiovascular, digestive, urinary, respiratory, blood, nervous, endocrine system and other serious primary diseases
  • Patients with bleeding, allergy constitution
  • Patients with abnormal skin or peripheral nerve sensation, abnormal pain sensation, skin ulceration at the sensitization detection site
  • Patients with unsatisfactory clinical treatment of hypertension and diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975140


Contacts
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Contact: Shourui Huang 18381081190 ext +86 531239462@qq.com
Contact: Jin Chen 18980601798 ext +86 598208009@qq.com

Locations
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China, Sichuan
The West China Hospital of Sichuan university
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital

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Responsible Party: Sun Xin, the Director of Chinese Evidence-based Medicine Center, West China Hospital
ClinicalTrials.gov Identifier: NCT03975140     History of Changes
Other Study ID Numbers: 81590955
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms