Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

Overview

Hypothesis: acupoint application is effective for managing chronic stable angina pectoris. Aim: to evaluate the efficacy and safety of acupoint application on the specific acupoints for chronic stable angina pectoris. Design: A Randomized, Controlled,Double Blind trial. 200 participants will be included. Four arms: herbal medicine application on acupoint group , placebo application on acupoint group , herbal medicine application on non-acupoint group and placebo application on non-acupoint group.

Full Title of Study: “Effect of Acupoint Application With Herbal Medicine in Patients With Stable Angina Pectoris: Randomized, Controlled,Double Blind Clinical Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2015

Detailed Description

Acupoint application with herbal medicine is a kind of external treatment of traditional Chinese medicine and has a long history in China, which is use herbal medicine made of plaster and stick to specific acupoints, using the double effects of acupoints and herb to treat disease. In China, acupoint application with herbal medicine has been used in clinical treatment of angina pectoris, but there is no convincing evidence for the efficacy of acupoint application for angina pectoris, due to low methodologic quality and small sample size. The investigators designed the Randomized, Controlled, Double Blind clinical trial to investigates the efficacy of acupoint application in treating angina pectoris, the purpose of this study is to provide the convincing evidence for acupoint application treatment of angina pectoris.

Interventions

  • Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)
    • Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.
  • Device: acupoint
    • select acupoint according to traditional Chinese medicine
  • Drug: Aspirin: 100mg qd; Metoprolol:25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
    • foundation treatment

Arms, Groups and Cohorts

  • Experimental: Herbal application on acupoint group
    • Containing the herbal medicine application on the specific acupoints plus foundation treatment
  • Placebo Comparator: Placebo application on acupoint
    • Not containing herbal medicine application on the specific acupoints plus foundation treatment
  • Placebo Comparator: Herbal application on non-acupoint group
    • Containing the herbal medicine application on the non-acupoints plus foundation treatment
  • Sham Comparator: Placebo application on non-acupoint
    • Not containing herbal medicine application on the non-acupoints plus foundation treatment

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline Number of angina attacks at 12 weeks
    • Time Frame: at baseline,4, 8weeks after inclusion
    • The change frequency of angina attack during every 4-week.

Secondary Measures

  • Change from Baseline the severity of angina ( VAS score) at 12 weeks
    • Time Frame: at baseline,4, 8weeks after inclusion
    • The VAS score evaluation angina pain severity
  • Change from Baseline the dosage of nitroglycerin at 12 weeks
    • Time Frame: at baseline,4, 8weeks after inclusion
    • Observed reduction in the dose of nitroglycerin
  • Seattle Angina Questionnaire
    • Time Frame: at baseline,4, 8weeks after inclusion
  • self-rating anxiety scale
    • Time Frame: at baseline,4, 8weeks after inclusion
  • Self-rating Depression Scale
    • Time Frame: at baseline,4, 8weeks after inclusion

Participating in This Clinical Trial

Inclusion Criteria

1.Meet the diagnostic criteria of American College of Cardiology(ACC)/American Heart Association (AHA) angina pectoris of coronary heart disease. 2.35 ≤ age ≤ 85 years, both male and female. 3.The onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week. 4.Patients signed the informed consent Exclusion Criteria:

1. age≤35 or age≥85. 2. Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months. 3. history of diabetes. 4. Co-infection or bleeding, allergic. 5. Currently participating in other clinical trials

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chengdu University of Traditional Chinese Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fanrong Liang, Principal Investigator, Chengdu University of TCM

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