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A multicenter, randomized, double-blind, placebo-controlled study on the efficacy and safety of Shexiang Baoxin Pill on coronary microvascular dysfunction

A multicenter, randomized, double-blind, placebo-controlled study on the efficacy and safety of Shexiang Baoxin Pill on coronary microvascular dysfunction

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003503
Enrollment
Unknown
Registered
2020-07-20
Start date
2020-09-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary microvascular dysfunction

Interventions

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) 18-80 years old patients, both male and female; 2) Selective coronary angiography or coronary CTA showed that the diameter of coronary artery was = 2.5mm, the degree of vascular stenosis was < 50%, and there was no myocardial bridge; 3) They were able to do treadmill exercise and had positive results in treadmill test (EET); 4) There were angina pectoris symptoms; 5) The patients were willing to follow up and sign informed consent; All the above criteria should be met.

Exclusion criteria

Exclusion criteria: 1) Coronary heart disease complicated with hypertrophic cardiomyopathy; 2) Patients with AMI, PCI, CABG history, cardiac myobridge or CTA in angiographic results; 3) Patients with severe medical diseases (liver, kidney, hematopoietic system and other serious primary diseases); 4) Mental disorders and mental disorders; 5) Patients with pulmonary failure and NYHA cardiac function grade III-IV who can not carry out exercise test; 6) The contraindications of Shexiang Baoxin Pill: forbidden for pregnant women; 7) Those who have been known to be allergic to Shexiang Baoxin Pills; 8) Recently, patients have regularly taken Shexiang Baoxin Pills and other anti ischemic Chinese medicines, or contain borneol, Bufonis and other ingredients in Shexiang Baoxin Pills; 9) The results showed that frequent ventricular premature beats, ventricular tachycardia, atrial fibrillation, sinoatrial block, atrioventricular conduction block, left bundle branch block and right bundle branch block may affect the judgment of exercise electrocardiogram results; 10) There are other factors that are not suitable to participate in the experiment; One of the exclusion criteria can be excluded.

Design outcomes

Primary

MeasureTime frame
At the end of the treatment, the heart rate abnormal recovery rate (HRR) between Shexiang Baoxin Pill group and placebo group during exercise treadmill ECG test was different;

Secondary

MeasureTime frame
At the end of the treatment, the abnormal response rate of blood pressure between Shexiang Baoxin Pill group and placebo group in treadmill ECG test was different;

Countries

China

Contacts

Public ContactYanqiu Chen

Shanghai Hutchison Pharmaceuticals

chenyanqiu@shpl.com.cn+86 18101812885

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026