Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

Chengdu University of Traditional Chinese Medicine

Status and phase: Completed; Early Phase 1

Conditions: Stable Angina Pectoris

Treatments: Device: acupoint; Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech); Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.

Study type: Interventional

Funder types: Other

Identifiers

NCT02029118

2011SZ0302.2

Details and patient eligibility

About

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 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.

Enrollment: 200 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

Herbal application on acupoint group

Experimental group

Description:

Containing the herbal medicine application on the specific acupoints plus foundation treatment

Treatment:

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

Device: acupoint

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

Placebo application on acupoint

Placebo Comparator group

Description:

Not containing herbal medicine application on the specific acupoints plus foundation treatment

Treatment:

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

Device: acupoint

Herbal application on non-acupoint group

Placebo Comparator group

Description:

Containing the herbal medicine application on the non-acupoints plus foundation treatment

Treatment:

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

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

Placebo application on non-acupoint

Sham Comparator group

Description:

Not containing herbal medicine application on the non-acupoints plus foundation treatment

Treatment:

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