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

Primary Purpose

Stable Angina Pectoris

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)
acupoint
Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina Pectoris focused on measuring Acupoint Application,Stable Angina Pectoris,herbal medicine

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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:

  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

Sites / Locations

  • Affiliated hospital of Chengdu University of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Sham Comparator

Arm Label

Herbal application on acupoint group

Placebo application on acupoint

Herbal application on non-acupoint group

Placebo application on non-acupoint

Arm Description

Containing the herbal medicine application on the specific acupoints plus foundation treatment

Not containing herbal medicine application on the specific acupoints plus foundation treatment

Containing the herbal medicine application on the non-acupoints plus foundation treatment

Not containing herbal medicine application on the non-acupoints plus foundation treatment

Outcomes

Primary Outcome Measures

Change from Baseline Number of angina attacks at 12 weeks
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
The VAS score evaluation angina pain severity
Change from Baseline the dosage of nitroglycerin at 12 weeks
Observed reduction in the dose of nitroglycerin
Seattle Angina Questionnaire
self-rating anxiety scale
Self-rating Depression Scale

Full Information

First Posted
November 24, 2013
Last Updated
February 13, 2020
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02029118
Brief Title
Acupoint Application in Patients With Stable Angina Pectoris (AASAP)
Acronym
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris
Keywords
Acupoint Application,Stable Angina Pectoris,herbal medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Herbal application on acupoint group
Arm Type
Experimental
Arm Description
Containing the herbal medicine application on the specific acupoints plus foundation treatment
Arm Title
Placebo application on acupoint
Arm Type
Placebo Comparator
Arm Description
Not containing herbal medicine application on the specific acupoints plus foundation treatment
Arm Title
Herbal application on non-acupoint group
Arm Type
Placebo Comparator
Arm Description
Containing the herbal medicine application on the non-acupoints plus foundation treatment
Arm Title
Placebo application on non-acupoint
Arm Type
Sham Comparator
Arm Description
Not containing herbal medicine application on the non-acupoints plus foundation treatment
Intervention Type
Drug
Intervention Name(s)
Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)
Other Intervention Name(s)
Herbal medicine application
Intervention Description
Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.
Intervention Type
Device
Intervention Name(s)
acupoint
Other Intervention Name(s)
acupuncture point
Intervention Description
select acupoint according to traditional Chinese medicine
Intervention Type
Drug
Intervention Name(s)
Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
Other Intervention Name(s)
basic treatment
Intervention Description
foundation treatment
Primary Outcome Measure Information:
Title
Change from Baseline Number of angina attacks at 12 weeks
Description
The change frequency of angina attack during every 4-week.
Time Frame
at baseline,4, 8weeks after inclusion
Secondary Outcome Measure Information:
Title
Change from Baseline the severity of angina ( VAS score) at 12 weeks
Description
The VAS score evaluation angina pain severity
Time Frame
at baseline,4, 8weeks after inclusion
Title
Change from Baseline the dosage of nitroglycerin at 12 weeks
Description
Observed reduction in the dose of nitroglycerin
Time Frame
at baseline,4, 8weeks after inclusion
Title
Seattle Angina Questionnaire
Time Frame
at baseline,4, 8weeks after inclusion
Title
self-rating anxiety scale
Time Frame
at baseline,4, 8weeks after inclusion
Title
Self-rating Depression Scale
Time Frame
at baseline,4, 8weeks after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanrong Liang
Organizational Affiliation
Chengdu University of TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated hospital of Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34387828
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.
Results Reference
derived
PubMed Identifier
25250055
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.
Results Reference
derived

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Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

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