Atherosclerotic Heart Disease With Angina NosCSCD-TCMNCT04022031
Clinical Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
An observational study of Atherosclerotic Heart Disease With Angina Nos, run by Tianjin University of Traditional Chinese Medicine at 1 site in China.
Trial summary
A prospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.Collect primary and secondary efficacy indicators such as the incidence of cardiovascular events, using clinical samples to detect genomics, proteomics, metabolomics… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Atherosclerotic Heart Disease With Angina Nos
- What is being tested?
- Chinese patent medicine
- Type of treatment
- Pill or oral medicine
- How many people
- 12,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2022
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: The collaboration network of coronary heart disease research medical units formed by the research group, including the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Nankai Hospital, Tianjin Medical University General Hospital，a total of 5 hospitals.
Who may be able to join
- Voluntarily participate, understand and sign the informed consent form;
- Age 35-75 years old, gender is not limited;
- Patients with coronary heart disease and angina pectoris in the Department of Cardiology or Outpatient Department, the diagnosis of angina pectoris meets the diagnostic criteria of Western medicine and the standard of TCM syndrome differentiation;
- Patients who met the criteria for drug treatment, the exposed group was treated with traditional Chinese medicine combined with Western medicine, and the non-exposed group was treated with Western medicine alone.
Who cannot join
- Combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain;
- Patients with severe symptoms and uncontrollable angina pectoris, with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and serious metabolic diseases;
- Pregnant women, lactating women or women of childbearing age who have birth requirements;
- Mental patients, or cognitive dysfunction;
- Participated in other clinical trials in the last 3 months;
- Allergic persons, or those known to be allergic to therapeutic drugs;
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- It is expected that the compliance is poor and it is not possible to visit regularly;
- Patients who do not have a current address or whose current address is incomplete and have no contact number;
- The investigator believes that there are other situations that are not suitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
About this study
Official title: Prospective Cohort Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
A prospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.Collect primary and secondary efficacy indicators such as the incidence of cardiovascular events, using clinical samples to detect genomics, proteomics, metabolomics, intestinal flora and sclerotia.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.
- Being tested
- Chinese patent medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese patent medicineDrug
Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Chinese patent medicine combined with western medicine routine Receives: Drug: Chinese patent medicine | |
| Non-exposed group | Western medicine routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiovascular events
These include acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).
Measured: one year
Secondary outcomes (5)
Death from all causes
Measured: one year
Re-admission due to cardiovascular events
Measured: one year
Seattle Angina Questionnaire
Measured: three months
Clinical biochemical test
Measured: three months
Film degree exam
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Heart Disease With Angina NosStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,400 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
- NCT04022031
- Sponsor's protocol ID
- CSCD-TCM
- Acronym
- CSCD-TCM
- Status last verified
- Jul 2019
- First submitted
- 13 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Adjuvant Treatment of Coronary Heart Disease Angina Pectoris With Chinese Patent Medicine
- ClinicalTrials.gov ID
- NCT04022031
- Acronym / sponsor ID
- CSCD-TCM / CSCD-TCM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,400 participants (estimated)
- Lead sponsor
- Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 16 Jul 2019 (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.
A prospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.Collect primary and secondary efficacy indicators such as the incidence of cardiovascular events, using clinical samples to detect genomics, proteomics, metabolomics, intestinal flora and sclerotia.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Drug: Chinese patent medicineChinese patent medicine combined with western medicine routine |
| Non-exposed group | – | –Western medicine routine treatment |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The collaboration network of coronary heart disease research medical units formed by the research group, including the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Nankai Hospital, Tianjin Medical University General Hospital，a total of 5 hospitals.
Key inclusion criteria (4 listed)
- Voluntarily participate, understand and sign the informed consent form;
- Age 35-75 years old, gender is not limited;
- Patients with coronary heart disease and angina pectoris in the Department of Cardiology or Outpatient Department, the diagnosis of angina pectoris meets the diagnostic criteria of Western medicine and the standard of TCM syndrome differentiation;
- Patients who met the criteria for drug treatment, the exposed group was treated with traditional Chinese medicine combined with Western medicine, and the non-exposed group was treated with Western medicine alone.
Key exclusion criteria (9 listed)
- Combined with other heart diseases, neurosis, menopausal syndrome, hyperthyroidism, cervical or vertebral artery type cervical spondylosis, gastro-oesophageal reflux disease or esophageal hiatus hernia may cause chest pain;
- Patients with severe symptoms and uncontrollable angina pectoris, with acute myocardial infarction, heart failure, myocarditis, cardiomyopathy, severe heart valve disease, liver failure or renal failure, malignant tumors and serious metabolic diseases;
- Pregnant women, lactating women or women of childbearing age who have birth requirements;
- Mental patients, or cognitive dysfunction;
- Participated in other clinical trials in the last 3 months;
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 |
|---|---|---|
| Chinese patent medicineShexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill. | Drug | Exposed group |
Primary outcome
Incidence of cardiovascular events
Time frame: one year
These include acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).
5 secondary outcomes
Death from all causes
Time frame: one year
Re-admission due to cardiovascular events
Time frame: one year
Seattle Angina Questionnaire
Time frame: three months
Clinical biochemical test
Time frame: three months
Film degree exam
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Atherosclerotic Heart Disease With Angina Nos, 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 4 inclusion and 9 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 17 Jul 2019. 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?
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?
Incidence of cardiovascular events (time frame: one 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 17 Jul 2019.