Coronary Microvascular DiseasePhase 4CMVDNCT06699420
Qishenyiqi Dripping Pill for Coronary Microvascular Disease
A Phase 4 study testing Qishenyiqi dripping pills 1 bag, three times a day in people with Coronary Microvascular Disease, run by Qilu Hospital of Shandong University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Microvascular Disease
- What is being tested?
- Qishenyiqi dripping pills 1 bag, three times a day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 3 sitesChina
- Study dates
- 8 Nov 2023to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 2 recruiting
- Active, not recruiting
Qianfoshan Hospital, Shandong University
Jinan, Shandong, 250012
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Panpan Hao, Dr, 18560086593, panda.how@sdu.edu.cn
- Recruiting
Jinan Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250031
Bin Li, Dr, 13370586671, qingquan0615@163.com
About this study
Official title: The Efficacy and Safety of Qishenyiqi Dripping Pill in Patients With Coronary Microvascular Disease
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
- Being tested
- Qishenyiqi dripping pills 1 bag, three times a day, Placebo 1 bag, three times a day
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qishenyiqi dripping pills 1 bag, three times a dayDrug
Qishenyiqi dripping pills, 1 bag once, three times a day, 12 months
Placebo 1 bag, three times a dayDrug
Placebo, 1 bag once, three times a day, 12 months
| Study group | Role | What they receive |
|---|---|---|
| Qishenyiqi Dripping Pill | Experimental | Not described Receives: Drug: Qishenyiqi dripping pills 1 bag, three times a day |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo 1 bag, three times a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start8 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan-Pan Hao, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699420
- Sponsor's protocol ID
- Qishenyiqi for CMVD
- Acronym
- CMVD
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Qishenyiqi Dripping Pill in Patients With Coronary Microvascular Disease
- ClinicalTrials.gov ID
- NCT06699420
- Acronym / sponsor ID
- CMVD / Qishenyiqi for CMVD
- Conditions
- Coronary Microvascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qishenyiqi dripping pills 1 bag, three times a dayQishenyiqi dripping pills, 1 bag once, three times a day, 12 months | Drug | Qishenyiqi Dripping Pill |
| Placebo 1 bag, three times a dayPlacebo, 1 bag once, three times a day, 12 months | Drug | Placebo |
Primary outcome
Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Qishenyiqi dripping pills 1 bag, three times a day in people with Coronary Microvascular Disease, run by Qilu Hospital of Shandong University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Panpan Hao, Dr. (8618560086593, panda.how@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.