Coronary Heart Disease (CHD)Phase 2NCT06709638
Clinical Evidence Based and TCM Phenotype Group Study of Zhilong Huoxue Tongyu Capsule in the Treatment of Stable Angina Pectoris of Coronary Heart Disease (Qi Deficiency and Blood Stasis Syndrome)
A Phase 2 study testing Zhilong Huoxue Tongyu capsule in people with Coronary Heart Disease (CHD), run by Jiang Hanmei at 1 site in China.
Trial summary
This study intends to prove the clinical effect of Zhidong Huoxue Tongyu capsule in the treatment of stable angina pectoris with qi deficiency and blood stasis syndrome from the perspective of TCM syndrome differentiation and treatment. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease (CHD)
- What is being tested?
- Zhilong Huoxue Tongyu capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy control group: (1) no clinical symptoms, heart color Doppler ultrasound, CTA showed no coronary heart disease and other organic heart disease; (2) Age: over 40 years old; (3) Matched with the basic information of gender, culture and education of the treatment group and the control group; (4) Voluntarily sign informed consent.
- Treatment and control groups: (1) Western medicine meets the diagnostic criteria of stable angina pectoris of coronary heart disease, and there is no change in the frequency, duration, trigger or relief mode of angina pectoris attacks in the past 60 days. There was no evidence of recent myocardial injury (normal serum cardiac markers troponin T or troponin I, and no abnormal resting electrocardiogram showing significant ST-segment elevation) and angina grade I-IV. Coronary angiography or coronary CTA within 1 year: 50%< Degree of coronary artery stenosis < 75% (including left anterior descending artery, right coronary artery, left circumflex artery, and left main artery) or 50%< Degree of coronary branch vessel stenosis < 100% lesions (except main coronary arteries, such as diagonal branches). (2) consistent with TCM syndrome of Qi deficiency and blood stasis; (3) age ≥40 years old, gender is not limited; (4) Those who voluntarily sign informed consent after communication.
Who cannot join
- Healthy people: (1) liver dysfunction, renal dysfunction; (2) Participating in other clinical investigators within the past two months; (3) pregnant women, those who plan to be pregnant or lactating women.
- Patients with stable angina pectoris syndrome of qi deficiency and blood stasis: (1) Those who did not meet the inclusion criteria; (2) complicated with severe hepatic and renal dysfunction; (3) pregnant and lactating women, patients with allergic constitution and a history of mental illness; (4) Acute myocardial infarction, congenital heart disease; Valvular heart disease; Myocardial infarction within the last 2 months; Patients who already have pacemakers and coronary and other stents that are not suitable for MRI materials; Malignant tumors.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University
Luzhou, Sichuan, 646000
About this study
This study intends to prove the clinical effect of Zhidong Huoxue Tongyu capsule in the treatment of stable angina pectoris with qi deficiency and blood stasis syndrome from the perspective of TCM syndrome differentiation and treatment. To detect metabolites in serum, urine and feces of patients with stable angina pectoris syndrome of qi deficiency and blood stasis by LC-MS metabolomics technology. Compared with normal control group, differential metabolites were found to provide molecular basis for the diagnosis of the disease. Metabolomics technology based on LC-MS was used to analyze the metabolites in serum, urine and feces before and after the treatment of Zhulong Huoxue Tongyu capsule in stable angina pectoris with qi deficiency and blood stasis syndrome. To provide laboratory evidence for Zhilong Huoxue Tongyu capsule in the treatment of stable angina pectoris with qi deficiency and blood stasis syndrome.
- Conditions
- Coronary Heart Disease (CHD)
- Being tested
- Placebo Comparator, Zhilong Huoxue Tongyu capsule
- Keywords
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ComparatorOther
Placebo Comparator
Zhilong Huoxue Tongyu capsuleDrug
Zhilong Huoxue Tongyu capsule
| Study group | Role | What they receive |
|---|---|---|
| Zhilong Huoxue Tongyu capsule | Experimental | Not described Receives: Drug: Zhilong Huoxue Tongyu capsule |
| Placebo Comparator | Placebo comparator | Not described Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
TCM syndrome integral scale
Measured: From enrollment to 60 days after treatment
CCS angina grading
Measured: From enrollment to 60 days after treatment
The number of angina attacks
Measured: From enrollment to 60 days after treatment
Nitroglycerin usage
Measured: From enrollment to 60 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiang Hanmei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiang Hanmei, Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709638
- Sponsor's protocol ID
- Clinical evidence based
- Status last verified
- Feb 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evidence Based and TCM Phenotype Group Study of Zhilong Huoxue Tongyu Capsule in the Treatment of Stable Angina Pectoris of Coronary Heart Disease (Qi Deficiency and Blood Stasis Syndrome)
- ClinicalTrials.gov ID
- NCT06709638
- Acronym / sponsor ID
- Clinical evidence based
- Conditions
- Coronary Heart Disease (CHD)
- Keywords
- Coronary Heart Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Jiang HanmeiUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 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.
This study intends to prove the clinical effect of Zhidong Huoxue Tongyu capsule in the treatment of stable angina pectoris with qi deficiency and blood stasis syndrome from the perspective of TCM syndrome differentiation and treatment. To detect metabolites in serum, urine and feces of patients with stable angina pectoris syndrome of qi deficiency and blood stasis by LC-MS metabolomics technology. Compared with normal control group, differential metabolites were found to provide molecular basis for the diagnosis of the disease. Metabolomics technology based on LC-MS was used to analyze the metabolites in serum, urine and feces before and after the treatment of Zhulong Huoxue Tongyu capsule in stable angina pectoris with qi deficiency and blood stasis syndrome. To provide laboratory evidence for Zhilong Huoxue Tongyu capsule in the treatment of stable angina pectoris with qi deficiency and blood stasis syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zhilong Huoxue Tongyu capsule | Experimental | Drug: Zhilong Huoxue Tongyu capsule |
| Placebo Comparator | Placebo comparator | Other: Placebo Comparator |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy control group: (1) no clinical symptoms, heart color Doppler ultrasound, CTA showed no coronary heart disease and other organic heart disease; (2) Age: over 40 years old; (3) Matched with the basic information of gender, culture and education of the treatment group and the control group; (4) Voluntarily sign informed consent.
- Treatment and control groups: (1) Western medicine meets the diagnostic criteria of stable angina pectoris of coronary heart disease, and there is no change in the frequency, duration, trigger or relief mode of angina pectoris attacks in the past 60 days. There was no evidence of recent myocardial injury (normal serum cardiac markers troponin T or troponin I, and no abnormal resting electrocardiogram showing significant ST-segment elevation) and angina grade I-IV. Coronary angiography or coronary CTA within 1 year: 50%< Degree of coronary artery stenosis < 75% (including left anterior descending artery, right coronary artery, left circumflex artery, and left main artery) or 50%< Degree of coronary branch vessel stenosis < 100% lesions (except main coronary arteries, such as diagonal branches). (2) consistent with TCM syndrome of Qi deficiency and blood stasis; (3) age ≥40 years old, gender is not limited; (4) Those who voluntarily sign informed consent after communication.
Key exclusion criteria (2 listed)
- Healthy people: (1) liver dysfunction, renal dysfunction; (2) Participating in other clinical investigators within the past two months; (3) pregnant women, those who plan to be pregnant or lactating women.
- Patients with stable angina pectoris syndrome of qi deficiency and blood stasis: (1) Those who did not meet the inclusion criteria; (2) complicated with severe hepatic and renal dysfunction; (3) pregnant and lactating women, patients with allergic constitution and a history of mental illness; (4) Acute myocardial infarction, congenital heart disease; Valvular heart disease; Myocardial infarction within the last 2 months; Patients who already have pacemakers and coronary and other stents that are not suitable for MRI materials; Malignant tumors.
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 |
|---|---|---|
| Placebo ComparatorPlacebo Comparator | Other | Placebo Comparator |
| Zhilong Huoxue Tongyu capsuleZhilong Huoxue Tongyu capsule | Drug | Zhilong Huoxue Tongyu capsule |
Primary outcome
TCM syndrome integral scale
Time frame: From enrollment to 60 days after treatment
CCS angina grading
Time frame: From enrollment to 60 days after treatment
The number of angina attacks
Time frame: From enrollment to 60 days after treatment
Nitroglycerin usage
Time frame: From enrollment to 60 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zhilong Huoxue Tongyu capsule in people with Coronary Heart Disease (CHD), run by Jiang Hanmei at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCM syndrome integral scale (time frame: From enrollment to 60 days after treatment). The study lists 4 primary outcomes in all. 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 29 Nov 2024.