Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03478332
Status:
UNKNOWN
Last Update Posted:
2018-03-27
First Post:
2018-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease
Sponsor:
Affiliated Hospital of Changchun University of Chinese Medicine
Organization:
Study Overview
Official Title:
Yangxinshi Pills Plus Conventional Treatment Versus Placebo Plus Conventional Treatment on the Exercise Tolerance of the Patients With Coronary Heart Disease: a Multi-center,Randomised Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Compared with conventional treatment of the coronary heart disease,the aim of the research is to find out if the addition of Yangxinshi pills on the basis of conventional treatment can improve exercise tolerance of patients with coronary heart disease, improve quality of life or restore social function and mental health
Detailed Description:
90 outpatients with clear diagnosis of coronary heart diseases will be recruited in the trial and randomized into two group.
One group are treated with Yangxinshi pills (provided by Qingdao Growtful Pharmaceutical Co., Ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine.
The primary end point is VO2max measured by cardiopulmonary exercise test after 3 months of treatment.
The secondary endpoint is:
1. Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；
2. Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；
3. The maximum walking distance of 6-minute walk test;
4. Changes of Seattle Angina Questionnaire;
5. Hamilton Depression Scale/ Hamilton Anxiety Scale.
The safety evaluation criteria is:
1. Adverse event and serious adverse event;
2. Vital signs;
3. Resting 12 lead ECG;
4. Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr).
One group are treated with Yangxinshi pills (provided by Qingdao Growtful Pharmaceutical Co., Ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine.
The primary end point is VO2max measured by cardiopulmonary exercise test after 3 months of treatment.
The secondary endpoint is:
1. Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；
2. Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；
3. The maximum walking distance of 6-minute walk test;
4. Changes of Seattle Angina Questionnaire;
5. Hamilton Depression Scale/ Hamilton Anxiety Scale.
The safety evaluation criteria is:
1. Adverse event and serious adverse event;
2. Vital signs;
3. Resting 12 lead ECG;
4. Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: