NCT02029118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2012

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

November 24, 2013

Last Update Submit

February 13, 2020

Conditions

Stable Angina Pectoris

Keywords

Acupoint Application,Stable Angina Pectoris,herbal medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change from Baseline the severity of angina ( VAS score) at 12 weeks

    at baseline,4, 8weeks after inclusion

  • Change from Baseline the dosage of nitroglycerin at 12 weeks

    at baseline,4, 8weeks after inclusion

  • Seattle Angina Questionnaire

    at baseline,4, 8weeks after inclusion

  • self-rating anxiety scale

    at baseline,4, 8weeks after inclusion

  • Self-rating Depression Scale

    at baseline,4, 8weeks after inclusion

Study Arms (4)

Herbal application on acupoint group

EXPERIMENTAL

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)Device: acupointDrug: 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

Device: acupointDrug: 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

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

Drug: Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.

Interventions

Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)DRUG

Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.

Also known as: Herbal medicine application
Herbal application on acupoint groupHerbal application on non-acupoint group
acupointDEVICE

select acupoint according to traditional Chinese medicine

Also known as: acupuncture point
Herbal application on acupoint groupPlacebo application on acupoint
Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.DRUG

foundation treatment

Also known as: basic treatment
Herbal application on acupoint groupHerbal application on non-acupoint groupPlacebo application on acupointPlacebo application on non-acupoint

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the diagnostic criteria of American College of Cardiology(ACC)/American Heart Association (AHA) angina pectoris of coronary heart disease.
  • ≤ age ≤ 85 years, both male and female.
  • The onset of angina pectoris≥3 months, and the frequency of angina attack≥2 a week.
  • Patients signed the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated hospital of Chengdu University of TCM

Chengdu, Sichuan, 610072, China

Location

Related Publications (2)

  • 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.

    PMID: 34387828DERIVED

  • 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.

    PMID: 25250055DERIVED

MeSH Terms

Conditions

Angina, Stable

Interventions

storaxisoborneolFrankincenseLeechingAcupuncture PointsAspirin

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex MixturesTherapeuticsMeridiansAcupuncture TherapyComplementary TherapiesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Fanrong Liang

    Chengdu University of TCM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2013

First Posted

January 7, 2014

Study Start

October 1, 2012

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

CN(1)