NCT04218916

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Typical duration for phase_2

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

January 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 3, 2020

Last Update Submit

January 3, 2020

Conditions

Coronary Microvascular Disease

Outcome Measures

Primary Outcomes (1)

  • Changes of Coronary Flow Reserve

    1 year

Study Arms (2)

Rhodiola Rosea Capsule

EXPERIMENTAL
Drug: Rhodiola Rosea Capsules

Placebo Capsule

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Rhodiola Rosea CapsulesDRUG

0.28g per capsule, 0.56g once (2 capsules), three times a day

Rhodiola Rosea Capsule
PlaceboDRUG

2 placebo capsules once, three times a day

Placebo Capsule

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
  • Coronary normal or stenosis \< 20%;
  • Ischemic depression in ST segment during resting or exercise;
  • Blood flow reserve (CFR) of the anterior descending coronary artery \< 2.0;
  • Subjects or their guardians agreed to participate in this study.

You may not qualify if:

  • Previous myocardial infarction or PCI or CABG treatment;
  • A history of heart failure or LVEF \< 50%;
  • Severe arrhythmia;
  • Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
  • A history of stroke within half a year;
  • Diabetes difficult to control;
  • Refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm;
  • Familial hypercholesterolemia;
  • Takayasu arteritis, Kawasaki disease or coronary artery malformation;
  • Pregnant or nursing, or having the intention to give birth within one year;
  • Hepatic or renal dysfunction;
  • Other diseases which may cause serious risks to patients;
  • Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
  • Allergic to contrast agents or blood products;
  • Patients who participated in clinical research of other drugs within 3 months before being selected.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 6, 2020

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2023

Last Updated

January 6, 2020

Record last verified: 2020-01