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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02029118
Other study ID # 2011SZ0302.2
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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