Acupoint Application in Patients With Stable Angina Pectoris (AASAP) (AASAP)

February 13, 2020 updated by: Chengdu University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Affiliated Hospital of Chengdu University of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Fanrong Liang, Chengdu University of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 24, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011SZ0302.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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