Coronary Heart DiseaseNCT02526381
Clinical Study On The Relation Among Prescription, Syndrome and Disease of Turbid Phlegm and Blood Stasis for Coronary Heart Disease
A study testing Danlou Tablets and Tongmai Yangxin Pills in people with Coronary Heart Disease, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Clinical study on patients with turbid phlegm and blood stasis syndrome and Qi -Yin Deficiency syndrome of coronary artery disease (CHD) compared with normal cases will be launched. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Danlou Tablets and Tongmai Yangxin Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Aug 2018
- Phase
- Interventional
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Selecting people aged between 35 and 65;
- Being up to the western diagnostic standard of chronic stable angina(complying with one or more of the following ): 1) There is a clear history of old myocardial infarction; 2) Have undergone coronary angiography or coronary Computed Tomography angiography(CTA) inspection hint antrum of coronary artery with at least a major branch pipe diameter stenosis≥50%; 3) Have received percutaneous coronary intervention (PCI) or Coronary Artery Bypass Grafting(CABG) treatment.
- They should sign the informed consent.
Who cannot join
- Had history of myocardial infarction or unstable angina, or coronary artery revascularization in 3 months.(coronary artery bypass graft or angioplasty);
- With other diseases that might cause chest pain, including heart diseases, neurosis, menopausal syndrome,hyperthyroidism, Cervical vertebra sickness (arteria vertebrals and spinal cord), gastroesophageal reflux disease or hiatal hernia.
- Using three or more of these drugs,namely beta blockers, calcium channel blockers, Energy metabolism drugs，and nitrate medications;
- With hypertension and blood pressure after Anti-hypertensive Medical Therapy is still on the high side (systolic pressure ≥160 mmHg,diastolic pressure ≥100 mmHg)combined with severe cardiopulmonary insufficiency or severe arrhythmia (Rapid auricular fibrillation, atrial flutter or Paroxysmal Supra VentricularTachycardia);
- Having liver disease or with unexplained serum transaminase continually increasing, or alanine aminotransferase(ALT) and aspartate aminotransferase (AST) greater than 2-fold of the upper limit of normal reference value;
- Abnormal renal function;
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- Merger of hematopoietic system diseases, or a serious primary diseases such as malignant tumor;
- Pregnant women, nursing mothers, or there is a requirement for fertility of women of childbearing age;
- Diabetic kidney disease, severe gouty nephropathy and other metabolic diseases;
- People with severe metabolic disease;
- People who are expected with poor medical compliance or can't be visited on a regular basis;
- Have participated in other clinical trials in recent 3 months;
- Researchers considering there are other cases in which people are not suitable for attending the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Chunquan Yu, Dr., 8622-59596309, ycq-4@163.com
About this study
Official title: Study on the Relation Between Syndrome and Disease of Turbid Phlegm and Blood Stasis for Coronary Heart Disease and Its Biological Basis
Clinical study on patients with turbid phlegm and blood stasis syndrome and Qi -Yin Deficiency syndrome of coronary artery disease (CHD) compared with normal cases will be launched. Detection of lipid metabolism, inflammation medium, endothelial cell injury, blood coagulation function evaluation of the relationship between disease and biochemical basis, detect plasma metabonomics and the gene expression profile chip, with "phlegm - lipid metabolic disorder", "stasis - microcirculation disorder", "alternating knot - inflammation mediated" and other system related to the biological basis. With Danlou Tablet for treatment, the investigators can observe result/effect index of turbid phlegm and blood stasis syndrome. Through comprehensive comparison of multi-level, multi-targets and multi-date biological index to discuss its sickness-syndrome-prescription corresponding relation and its biological basis.
- Conditions
- Coronary Heart Disease
- Being tested
- Danlou Tablets, Tongmai Yangxin Pills
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danlou TabletsDrug
Five tablets of Danlou Tablets (1.5g) will be given three times a day in addition to regular western medications for the 8 weeks
Tongmai Yangxin PillsDrug
Forty pills of Tongmai Yangxin Pills (4g) will be given two times a day in addition to regular western medications for the 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Danlou Tablets | Experimental | Danlou prescription is a tablet, each piece weighs 0.3 g, taken orally, three times a day, five at a time, from jilin Cornell's pharmaceutical corporation, Limited Liability Company . Receives: Drug: Danlou Tablets |
| Tongmai Yangxin Pills | Experimental | Tongmai Yangxin prescription is a pill,each pill weighs 0.1 g,taken orally, 2 times a day,40 pills at a time,produced by tianjin new pharmaceutical group corporation, Limited Liability Company . LeRenTang pharmaceutical. Receives: Drug: Tongmai Yangxin Pills |
| no drugs | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traditional Chinese Medicine symptom scores of Turbid Phlegm and Blood Stasis for Coronary Heart Disease
Measured: 12 weeks
Seattle Angina Questionnaire
Measured: 12 weeks
The Short Form (36) Health Survey, (SF-36)
Measured: 12 weeks
Self-reporting Inventory(symptom checklist-90)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunquan Yu, Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526381
- Sponsor's protocol ID
- 2014CB542902
- Status last verified
- Nov 2015
- First submitted
- 14 Aug 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relation Between Syndrome and Disease of Turbid Phlegm and Blood Stasis for Coronary Heart Disease and Its Biological Basis
- ClinicalTrials.gov ID
- NCT02526381
- Acronym / sponsor ID
- 2014CB542902
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- 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.
Clinical study on patients with turbid phlegm and blood stasis syndrome and Qi -Yin Deficiency syndrome of coronary artery disease (CHD) compared with normal cases will be launched. Detection of lipid metabolism, inflammation medium, endothelial cell injury, blood coagulation function evaluation of the relationship between disease and biochemical basis, detect plasma metabonomics and the gene expression profile chip, with "phlegm - lipid metabolic disorder", "stasis - microcirculation disorder", "alternating knot - inflammation mediated" and other system related to the biological basis. With Danlou Tablet for treatment, the investigators can observe result/effect index of turbid phlegm and blood stasis syndrome. Through comprehensive comparison of multi-level, multi-targets and multi-date biological index to discuss its sickness-syndrome-prescription corresponding relation and its biological basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Danlou Tablets | Experimental | Drug: Danlou TabletsDanlou prescription is a tablet, each piece weighs 0.3 g, taken orally, three times a day, five at a time, from jilin Cornell's pharmaceutical corporation, Limited Liability Company . |
| Tongmai Yangxin Pills | Experimental | Drug: Tongmai Yangxin PillsTongmai Yangxin prescription is a pill,each pill weighs 0.1 g,taken orally, 2 times a day,40 pills at a time,produced by tianjin new pharmaceutical group corporation, Limited Liability Company . LeRenTang pharmaceutical. |
| no drugs | No intervention | – |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Selecting people aged between 35 and 65;
- Being up to the western diagnostic standard of chronic stable angina(complying with one or more of the following ): 1) There is a clear history of old myocardial infarction; 2) Have undergone coronary angiography or coronary Computed Tomography angiography(CTA) inspection hint antrum of coronary artery with at least a major branch pipe diameter stenosis≥50%; 3) Have received percutaneous coronary intervention (PCI) or Coronary Artery Bypass Grafting(CABG) treatment.
- They should sign the informed consent.
Key exclusion criteria (13 listed)
- Had history of myocardial infarction or unstable angina, or coronary artery revascularization in 3 months.(coronary artery bypass graft or angioplasty);
- With other diseases that might cause chest pain, including heart diseases, neurosis, menopausal syndrome,hyperthyroidism, Cervical vertebra sickness (arteria vertebrals and spinal cord), gastroesophageal reflux disease or hiatal hernia.
- Using three or more of these drugs,namely beta blockers, calcium channel blockers, Energy metabolism drugs，and nitrate medications;
- With hypertension and blood pressure after Anti-hypertensive Medical Therapy is still on the high side (systolic pressure ≥160 mmHg,diastolic pressure ≥100 mmHg)combined with severe cardiopulmonary insufficiency or severe arrhythmia (Rapid auricular fibrillation, atrial flutter or Paroxysmal Supra VentricularTachycardia);
- Having liver disease or with unexplained serum transaminase continually increasing, or alanine aminotransferase(ALT) and aspartate aminotransferase (AST) greater than 2-fold of the upper limit of normal reference value;
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 |
|---|---|---|
| Danlou TabletsFive tablets of Danlou Tablets (1.5g) will be given three times a day in addition to regular western medications for the 8 weeks | Drug | Danlou Tablets |
| Tongmai Yangxin PillsForty pills of Tongmai Yangxin Pills (4g) will be given two times a day in addition to regular western medications for the 8 weeks | Drug | Tongmai Yangxin Pills |
Primary outcome
Traditional Chinese Medicine symptom scores of Turbid Phlegm and Blood Stasis for Coronary Heart Disease
Time frame: 12 weeks
Seattle Angina Questionnaire
Time frame: 12 weeks
The Short Form (36) Health Survey, (SF-36)
Time frame: 12 weeks
Self-reporting Inventory(symptom checklist-90)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Danlou Tablets and Tongmai Yangxin Pills in people with Coronary Heart Disease, run by Tianjin University of Traditional Chinese Medicine 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 3 inclusion and 13 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 20 Nov 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Chunquan Yu, Dr. (8622-59596309, ycq-4@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traditional Chinese Medicine symptom scores of Turbid Phlegm and Blood Stasis for Coronary Heart Disease (time frame: 12 weeks). 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 20 Nov 2015.