Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

Early Phase 1

Completed

• Conditions: Stable Angina Pectoris
• Interventions: Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech); Device: acupoint

• Registration Number: NCT02029118
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief Summary

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.

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-11-24
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Herbal application on acupoint group	Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)	Containing the herbal medicine application on the specific acupoints plus foundation treatment
Herbal application on acupoint group	acupoint	Containing the herbal medicine application on the specific acupoints plus foundation treatment
Placebo application on acupoint	acupoint	Not containing herbal medicine application on the specific acupoints plus foundation treatment
Herbal application on non-acupoint group	Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)	Containing the herbal medicine application on the non-acupoints plus foundation treatment

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Affiliated hospital of Chengdu University of TCM; 🇨🇳 Chengdu, Sichuan, China