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RecruitingNCT06699420CMVDUpdated Nov 21, 2024

Qishenyiqi Dripping Pill for Coronary Microvascular Disease

A Phase 4 interventional study of Qishenyiqi dripping pills 1 bag, three times a day and Placebo 1 bag, three times a day in Coronary Microvascular Disease, sponsored by Qilu Hospital of Shandong University. Recruiting at 3 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Qilu Hospital of Shandong University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Registered 1 year after the study started (first participant enrolled Nov 2023, registered Nov 2024).
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Microvascular Disease

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03

In context

Microvascular Angina

123 studies on the registry are indexed under Microvascular Angina; 36 are open to participants now.

This study's planned enrollment of 162 is above the median of 70 across 77 interventional studies indexed under Microvascular Angina.

Browse Microvascular Angina studies →

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
162 participants (estimated)

Study arms

  • Experimental
    Qishenyiqi Dripping Pill

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

  • Placebo comparator
    Placebo

    Drug: Placebo 1 bag, three times a day

Interventions

  • DrugQishenyiqi dripping pills 1 bag, three times a day

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

  • DrugPlacebo 1 bag, three times a day

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

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

07

Study locations

2 of 3 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06699420
Lead sponsor
Qilu Hospital of Shandong University
Responsible party
Pan-Pan Hao (Prof., Qilu Hospital of Shandong University) — Principal investigator
First posted
Nov 21, 2024
Start date
Nov 8, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Nov 21, 2024

Study contacts

Panpan Hao, Dr.
Contact
panda.how@sdu.edu.cn
8618560086593

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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