Qishenyiqi Dripping Pill for Coronary Microvascular Disease

NCT ID: NCT06699420

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To investigate the efficacy and safety of Qishenyiqi in patients with microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Qishenyiqi on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Microvascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Qishenyiqi Dripping Pill

Group Type EXPERIMENTAL

Qishenyiqi dripping pills 1 bag, three times a day

Intervention Type DRUG

Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo 1 bag, three times a day

Intervention Type DRUG

Placebo, 1 bag once, three times a day, 12 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Qishenyiqi dripping pills 1 bag, three times a day

Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months

Intervention Type DRUG

Placebo 1 bag, three times a day

Placebo, 1 bag once, three times a day, 12 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Previous myocardial infarction or PCI or CABG treatment;
* A history of heart failure;
* Severe arrhythmia;
* 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;
* Allergic to contrast agents or traditional Chinese medicines;
* Patients who participated in clinical research of other drugs within 3 months before being selected.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pan-Pan Hao

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Qianfoshan Hospital, Shandong University

Jinan, Shandong, China

Site Status ACTIVE_NOT_RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Panpan Hao, Dr.

Role: CONTACT

8618560086593

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Panpan Hao, Dr

Role: primary

18560086593

Bin Li, Dr

Role: primary

13370586671

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Qishenyiqi for CMVD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.