Clinical trial NCT02029118: Acupoint Application in Patients With Stable Angina Pectoris (AASAP)
Official title: Effect of Acupoint Application With Herbal Medicine in Patients With Stable Angina Pectoris: Randomized, Controlled,Double Blind Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stable Angina Pectoris
Keywords: Acupoint Application,Stable Angina Pectoris,herbal medicine
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Number of angina attacks at 12 weeks
timeFrame: at baseline,4, 8weeks after inclusion
Secondary outcomes:
measure: Change from Baseline the severity of angina ( VAS score) at 12 weeks
timeFrame: at baseline,4, 8weeks after inclusion
measure: Change from Baseline the dosage of nitroglycerin at 12 weeks
timeFrame: at baseline,4, 8weeks after inclusion
measure: Seattle Angina Questionnaire
timeFrame: at baseline,4, 8weeks after inclusion
measure: self-rating anxiety scale
timeFrame: at baseline,4, 8weeks after inclusion
measure: Self-rating Depression Scale
timeFrame: at baseline,4, 8weeks after inclusion
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Affiliated hospital of Chengdu University of TCM
state: Sichuan
Study officials:
affiliation: Chengdu University of TCM
name: Fanrong Liang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li DH, Xie J, Ren YL, Zheng H, Lyu JL, Leng JY, Zhang LL, Zhang J, Fan HL, Liang FR. Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill () for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial. Chin J Integr Med. 2021 Nov;27(11):838-845. doi: 10.1007/s11655-021-2870-3. Epub 2021 Aug 13.
citation: Ren Y, Li D, Zheng H, Lv J, Leng J, Zhang L, Zhang J, Fan H, Liang F. Acupoint application in patients with chronic stable angina pectoris: study protocol of a randomized, double-blind, controlled trial. Evid Based Complement Alternat Med. 2014;2014:619706. doi: 10.1155/2014/619706. Epub 2014 Aug 27.