Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

Stable Angina Pectoris Clinical Trial

— AASAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029118
• Other study ID #: 2011SZ0302.2
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2012
• Est. completion date: August 2015

Study information

• Verified date: February 2020
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Stable Angina Pectoris

Intervention

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.

Device:
• acupoint
select acupoint according to traditional Chinese medicine

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

Locations

Country	Name	City	State
China	Affiliated hospital of Chengdu University of TCM	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change from Baseline the dosage of nitroglycerin at 12 weeks	Observed reduction in the dose of nitroglycerin	at baseline,4, 8weeks after inclusion
Secondary	Seattle Angina Questionnaire		at baseline,4, 8weeks after inclusion
Secondary	self-rating anxiety scale		at baseline,4, 8weeks after inclusion
Secondary	Self-rating Depression Scale		at baseline,4, 8weeks after inclusion