NCT02280850

Brief Summary

Compared with placebo, assess of the efficacy and safety of Guanxin Shutong capsule to treat chronic stable angina (syndrome of blood stasis resistance), and the result will be used for the basis of later Ⅳ clinical trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

October 23, 2014

Last Update Submit

October 29, 2014

Conditions

Angina, Stable

Keywords

Angina

Outcome Measures

Primary Outcomes (2)

  • Therapeutic effect to Angina ( Average value of angina frequency)

    Record angina frequency per week. Record date is Start-up Stage 1st week, Start-up Stage 2st week, Interview Stage 1st week, Interview Stage 2st week, Interview Stage 3st week and Interview Stage 4st week (Toal of 6 times).

    6 weeks

  • Exercise treadmill testing (ETT)

    ST-segment displacement in electrocardiogram: Observe ST-segment displacement of J point after 60ms, including the degree of ST-segment depression.

    4 weeks

Secondary Outcomes (6)

  • Usage of nitroglycerine per day (average value)

    4 weeks

  • Seattle Angina Ques-tionnaire (SAQ)

    4 weeks

  • Scores on Chinese medical syndrome scale

    4 weeks

  • Electrocardiogram manifestation

    4 weeks

  • Time of angina break out from exercise beginning in ETT

    4 weeks

  • +1 more secondary outcomes

Other Outcomes (2)

  • Blood fat (TC, TG, HDL-C, LDL-C)

    4 weeks

  • Degree and duration of angina attack.

    4 weeks

Study Arms (2)

Guanxin Shutong Capsule

EXPERIMENTAL

3 capsules once, tid, Oral Duration: 4 weeks

Drug: Guanxin Shutong CapsuleDrug: nitroglycerine

Placebo Capsule

PLACEBO COMPARATOR

Placebo capsule and Guanxin Shutong Capsule the same appearance are made by SHAANXI BUCHANG PHARMACEUTICAL CO.,LTD. 3 capsules once, tid, Oral Duration: 4 weeks

Drug: Placebo CapsuleDrug: nitroglycerine

Interventions

Guanxin Shutong CapsuleDRUG

3 capsules three times a day; Duration: 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops.

Guanxin Shutong Capsule
Placebo CapsuleDRUG

3 capsules three times a day; Duration: 4 weeks.

Placebo Capsule
nitroglycerineDRUG

Adults: 0.25mg-0.5mg (half pill or 1 pill) once, sub-lingual. One more pill per 5 minutes untill pain relief. If total dose is 3 pills in 15 minutes and the pain is still in, please seek medical advice urgently. The participators in both arms who have agina symptom will take Nitroglycerine. So the accumulated consumption of participators is the one of the maesuremnts.

Guanxin Shutong CapsulePlacebo Capsule

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptom of chronic stable angina is sustained for 3 months or over 3 months (typical symptoms of myocardial ischemia occurred at least 2 times in the latest week, and angina type is stable angina (Canada CCS class Ⅰ、Ⅱ or Ⅲ);
  • Blood stasis resistance on traditional Chinese medicine syndrome differentiation;
  • Patients who meet the following any situation:
  • had coronary angiography and verified a least one main branch of coronary stenosis ≥50%;
  • have typical angina symptom, and also have positive ETT result or CTA shows at least one main branch of coronary stenosis ≥50%;
  • had history of myocardial infarct (at least 6 months).
  • Written informed consent.

You may not qualify if:

  • Acute coronary syndrome or highly suspected acute coronary syndrome;
  • Variant angina or unstable angina;
  • Myocardial infarction within the past 6 months;
  • Left main disease and without revascularization was verified through angiography or CTA;
  • Moderate to severe aortic stenosis, hypertrophic Obstructive Cardiomyopathy or congestive heart-failure (NYHA class Ⅲ-Ⅳ);
  • Patients who were received PCI/CABG within 1 year;
  • Patients who are poor control of high blood pressure (SBP\>170mmHg, or DBP\>100mmHg);
  • Patients who have hypotension (SBP\<90mmHg, DBP\<60mmHg) or had orthostatic hypotension;
  • ECG shows complete left bundle branch block, pre-excitation syndrome, left ventricular hypertrophy or pacemaker rhythm;
  • Hypohepatia (ALT or bilirubin level is higher than upper limit), renal insufficiency (serum creatinine level is higher than upper limit);
  • Active peptic ulcer or skin ulcer;
  • Diagnosed chest pain caused by severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, gallbladder-cardiac syndrome, gastroesophageal reflux, esophageal hiatus hernia or in aortic dissection;
  • Patients had hematological disorder, specific bleeding or warfarin caused bleeding;
  • Drug abuser, patients with history of alcoholism in the past 2 years or dependency to known drugs;
  • Psychopath;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110045, China

Location

Related Publications (1)

  • Li Y, Zhang L, Lv S, Wang X, Zhang J, Tian X, Zhang Y, Chen B, Liu D, Yang J, Dong P, Xu Y, Song Y, Shi J, Li L, Wang X, Han Y. Efficacy and safety of oral Guanxinshutong capsules in patients with stable angina pectoris in China: a prospective, multicenter, double-blind, placebo-controlled, randomized clinical trial. BMC Complement Altern Med. 2019 Dec 11;19(1):363. doi: 10.1186/s12906-019-2778-z.

    PMID: 31829173DERIVED

MeSH Terms

Conditions

Angina, StableAngina Pectoris

Interventions

guanxin shutongNitroglycerin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Officials

  • Lv Shuzheng

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

  • Zhang Yan

    The Affiliated Hospital of Liaoning Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Chen Bojun

    The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Luo Wei

    Xuzhou Central Hospital

    PRINCIPAL INVESTIGATOR

  • Jiang Binghua

    Shandong University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Zhang Zhenxian

    Luohe Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Xing Yanjun

    First Hospital of Shijiazhuang City

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Yaling, Academician

CONTACT

+86-24-28856123guanxinshutong@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2014

First Posted

November 3, 2014

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

CN(1)