Rhodiola Rosea for Coronary Microvascular Disease

Coronary Microvascular Disease Clinical Trial

Official title:

The Efficacy and Safety of Rhodiola Rosea in Patients With Coronary Microvascular Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04218916
• Other study ID #: Qilu Hospital
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2020
• Est. completion date: January 2023

Study information

• Verified date: January 2020
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effects of rhodiola rosea on coronary flow reserve and symptoms in patients with microvascular angina pectoris, and to evaluate adverse drug reactions. Long-term clinical follow-up of 1 to 3 years was conducted to evaluate the effect of rhodiola rosea on long-term adverse cardiovascular events in patients with coronary microvascular disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: January 2023
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;

2. Coronary normal or stenosis < 20%;

3. Ischemic depression in ST segment during resting or exercise;

4. Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;

5. Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

1. Previous myocardial infarction or PCI or CABG treatment;

2. A history of heart failure or LVEF < 50%;

3. Severe arrhythmia;

4. Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;

5. A history of stroke within half a year;

6. Diabetes difficult to control;

7. Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;

8. Familial hypercholesterolemia;

9. Takayasu arteritis, Kawasaki disease or coronary artery malformation;

10. Pregnant or nursing, or having the intention to give birth within one year;

11. Hepatic or renal dysfunction;

12. Other diseases which may cause serious risks to patients;

13. Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;

14. Allergic to contrast agents or blood products;

15. Patients who participated in clinical research of other drugs within 3 months before being selected.

Related Conditions & MeSH terms

• Coronary Microvascular Disease

Intervention

Drug:
• Rhodiola Rosea Capsules
0.28g per capsule, 0.56g once (2 capsules), three times a day
• Placebo
2 placebo capsules once, three times a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Coronary Flow Reserve		1 year