Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

Sponsor

Chengdu University of Traditional Chinese Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02029118

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stable Angina Pectoris	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.	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Herbal application on acupoint group 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) 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 Device: acupoint select acupoint according to traditional Chinese medicine Other Names: acupuncture point Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn. foundation treatment Other Names: basic treatment
Placebo Comparator: Placebo application on acupoint Not containing herbal medicine application on the specific acupoints plus foundation treatment	Device: acupoint select acupoint according to traditional Chinese medicine Other Names: acupuncture point Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn. foundation treatment Other Names: basic treatment
Placebo Comparator: Herbal application on non-acupoint group 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) 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 Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn. foundation treatment Other Names: basic treatment
Sham Comparator: Placebo application on non-acupoint 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. foundation treatment Other Names: basic treatment

Outcome Measures

Primary Outcome Measures

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

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
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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:

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