Stable Angina PectorisEarly Phase 1AASAPNCT02029118

Acupoint Application in Patients With Stable Angina Pectoris (AASAP)

A Early Phase 1 study testing Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech), acupoint and Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn. in people with Stable Angina Pectoris, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 85 years
Conditions the study is for: Stable Angina Pectoris
What is being tested?: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech), acupoint and Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteChina
Study dates: Oct 2012to Aug 2015
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Affiliated hospital of Chengdu University of TCM
Chengdu, Sichuan, 610072

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions: Stable Angina Pectoris
Being tested: 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.
Keywords: Acupoint Application,Stable Angina Pectoris,herbal medicine
Medical subject headings: Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)Drug
Also called Herbal medicine application
Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.
acupointDevice
Also called acupuncture point
select acupoint according to traditional Chinese medicine
Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.Drug
Also called basic treatment
foundation treatment

Study groups in NCT02029118
Study group	Role	What they receive
Herbal application on acupoint group	Experimental	Containing the herbal medicine application on the specific acupoints plus foundation treatment Receives: Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech); Device: acupoint; Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
Placebo application on acupoint	Placebo comparator	Not containing herbal medicine application on the specific acupoints plus foundation treatment Receives: Device: acupoint; Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
Herbal application on non-acupoint group	Placebo comparator	Containing the herbal medicine application on the non-acupoints plus foundation treatment Receives: Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech); Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
Placebo application on non-acupoint	Sham comparator	Not containing herbal medicine application on the non-acupoints plus foundation treatment Receives: Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline Number of angina attacks at 12 weeks
The change frequency of angina attack during every 4-week.
Measured: at baseline,4, 8weeks after inclusion

Secondary outcomes (5)

Change from Baseline the severity of angina ( VAS score) at 12 weeks
The VAS score evaluation angina pain severity
Measured: at baseline,4, 8weeks after inclusion
Change from Baseline the dosage of nitroglycerin at 12 weeks
Observed reduction in the dose of nitroglycerin
Measured: at baseline,4, 8weeks after inclusion
Seattle Angina Questionnaire
Measured: at baseline,4, 8weeks after inclusion
self-rating anxiety scale
Measured: at baseline,4, 8weeks after inclusion
Self-rating Depression Scale
Measured: at baseline,4, 8weeks after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Aug 2015

First posted7 Jan 2014 (estimated)
Study startOct 2012
Primary completionMay 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Stable Angina PectorisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02029118
Sponsor's protocol ID: 2011SZ0302.2
Acronym: AASAP
Status last verified: Feb 2020
First submitted: 24 Nov 2013
Last updated: 17 Feb 2020
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 34387828
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.
PubMed 25250055

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
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Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
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Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
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Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris

All Stable Angina Pectoris trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Acupoint Application With Herbal Medicine in Patients With Stable Angina Pectoris: Randomized, Controlled,Double Blind Clinical Study
ClinicalTrials.gov ID: NCT02029118
Acronym / sponsor ID: AASAP / 2011SZ0302.2
Conditions: Stable Angina Pectoris
Keywords: Acupoint Application,Stable Angina Pectoris,herbal medicine
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
Study start: Oct 2012
Primary completion: May 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 7 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Herbal application on acupoint group	Experimental	Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech), Device: acupoint, Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.Containing the herbal medicine application on the specific acupoints plus foundation treatment
Placebo application on acupoint	Placebo comparator	Device: acupoint, Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.Not containing herbal medicine application on the specific acupoints plus foundation treatment
Herbal application on non-acupoint group	Placebo comparator	Drug: Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech), Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.Containing the herbal medicine application on the non-acupoints plus foundation treatment
Placebo application on non-acupoint	Sham comparator	Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.Not containing herbal medicine application on the non-acupoints plus foundation treatment

Who may qualify

Ages: 35 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)Also: Herbal medicine applicationApplication containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.	Drug	Herbal application on acupoint group, Herbal application on non-acupoint group
acupointAlso: acupuncture pointselect acupoint according to traditional Chinese medicine	Device	Herbal application on acupoint group, Placebo application on acupoint
Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.Also: basic treatmentfoundation treatment	Drug	Herbal application on acupoint group, Herbal application on non-acupoint group, Placebo application on acupoint, Placebo application on non-acupoint

Primary outcome

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.

5 secondary outcomes

Change from Baseline the severity of angina ( VAS score) at 12 weeks
Time frame: at baseline,4, 8weeks after inclusion
Change from Baseline the dosage of nitroglycerin at 12 weeks
Time frame: at baseline,4, 8weeks after inclusion
Seattle Angina Questionnaire
Time frame: at baseline,4, 8weeks after inclusion
self-rating anxiety scale
Time frame: at baseline,4, 8weeks after inclusion
Self-rating Depression Scale
Time frame: at baseline,4, 8weeks after inclusion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
Derived from this study: PubMed 34387828Li 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.
Derived from this study: PubMed 25250055Ren 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.

Related trials for Stable Angina Pectoris

Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fanrong Liang principal investigator

Chengdu University of TCM

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Number of angina attacks at 12 weeks (time frame: at baseline,4, 8weeks after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02029118, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.