Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stable Angina Pectoris

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Herbal application on acupoint group<br>Containing the herbal medicine application on the specific acupoints plus foundation treatment | Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)<br>* Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.<br>* Other names: Herbal medicine application;Device: acupoint<br>* select acupoint according to traditional Chinese medicine<br>* Other names: acupuncture point;Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.<br>* foundation treatment<br>* Other names: basic treatment;|
| Placebo Comparator: Placebo application on acupoint<br>Not containing herbal medicine application on the specific acupoints plus foundation treatment | Device: acupoint<br>* select acupoint according to traditional Chinese medicine<br>* Other names: acupuncture point;Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.<br>* foundation treatment<br>* Other names: basic treatment;|
| Placebo Comparator: Herbal application on non-acupoint group<br>Containing the herbal medicine application on the non-acupoints plus foundation treatment | Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)<br>* Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.<br>* Other names: Herbal medicine application;Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.<br>* foundation treatment<br>* Other names: basic treatment;|
| Sham Comparator: Placebo application on non-acupoint<br>Not containing herbal medicine application on the non-acupoints plus foundation treatment | Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.<br>* foundation treatment<br>* Other names: basic treatment;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupoint Application,Stable Angina Pectoris,herbal medicine