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Completed

NCT Number: NCT02029118

Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

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.

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Key information

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Affiliated hospital of Chengdu University of TCM

Chengdu, Sichuan, 610072, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)

Drug

Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.

Other names: Herbal medicine application

acupoint

Device

select acupoint according to traditional Chinese medicine

Other names: acupuncture point

Aspirin: 100mg qd; Metoprolol:25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.

Drug

foundation treatment

Other names: basic treatment

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Seattle Angina Questionnaire

    Time frame: at baseline,4, 8weeks after inclusion

  4. self-rating anxiety scale

    Time frame: at baseline,4, 8weeks after inclusion

  5. Self-rating Depression Scale

    Time frame: at baseline,4, 8weeks after inclusion

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Acronym: AASAP

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 7, 2014
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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