Qishenyiqi Dripping Pill for Coronary Microvascular Disease

NCT06699420 | Recruiting Phase 4

• 1 other identifier: Qishenyiqi for CMVD
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Coronary Microvascular Disease

Outcome Measures

Primary Outcomes (1)

• Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up

  1 year

Study Arms (2)

Qishenyiqi Dripping Pill

EXPERIMENTAL

Drug: Qishenyiqi dripping pills 1 bag, three times a day

Placebo

PLACEBO COMPARATOR

Drug: Placebo 1 bag, three times a day

Interventions

Qishenyiqi dripping pills 1 bag, three times a day DRUG

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

Qishenyiqi Dripping Pill

Placebo 1 bag, three times a day DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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;
• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (3)

Qianfoshan Hospital, Shandong University

Jinan, Shandong, 250012, China

ACTIVE NOT RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250031, China

RECRUITING

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Panpan Hao, Dr.

CONTACT

8618560086593; panda.how@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: Prof.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: November 8, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)