Chronic Stable AnginaNCT04498962
The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial
A study testing Danzhu Fuyuan Granule in people with Chronic Stable Angina and Vascular Dementia, run by Jingqing Hu at 7 sites in China.
Trial summary
This study is designed as a bayesian basket trial , which aims to evaluate the efficacy of Danzhu Fuyuan Granule in patients with Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stable Angina, Vascular Dementia, Idiopathic Membranous Nephropathy
- What is being tested?
- Danzhu Fuyuan Granule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 7 sitesChina
- Study dates
- Aug 2020to 1 Dec 2021
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient must be between the ages of 40 and 70 years
- Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation.
- Patient must match the diagnostic criteria for chronic stable angina set by Chinese Medical Association;
- The number of angina pectoris attacked in the past 3 months was more than 2 times per week
- Class I or Class II, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System
- Patients who met the clinical diagnostic criteria for Syndrome of intermingled phlegm and blood stasis with chronic stable angina;
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- The results of Treadmill Exercise Test were positive;
- All other Traditional Chinese Medicine interventions (including decoction, granule, proprietary Chinese medicine, acupuncture, etc.) should be stopped for 2 weeks or more;
- They signed the consent form voluntarily and agreed to participate in the research.
- The age of the subjects was 35-85 years old;
- It was in accordance with the diagnostic standard of Western medicine for vascular dementia;
- It is in accordance with the diagnostic standard of TCM phlegm and blood stasis syndrome of vascular dementia;
- They signed informed consent and volunteered to participate in the study;
- The patients are expected to follow up within half a year.
Who cannot join
- patients who are diagnosed with acute coronary syndrome (including acute myocardial infarction or unstable angina pectoris) occurred within 2 months before enrollment, or had undergone revascularization within 3 months before enrollment, or planned to undergo revascularization during the study period;
- Patients who are unable to complete Treadmill Exercise Test for various reasons, including absolute and relative contraindications;
- Severe primary diseases such as respiratory, blood system or malignant tumor, or known renal insufficiency (serum creatinine (CR) > 221 umol /L in male, or 177 umol / L in female);
- Patients with epilepsy who had bleeding tendency, history of cerebral hemorrhage, or needed anticonvulsant therapy;
- Patients with active liver disease, or accompanied with unexplained continuous increase of serum transaminase, or the detection value of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) is more than twice the upper limit of normal reference value;
- Pregnancy or lactation;
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- patients can't stopped taking long-acting nitrates during the clinical trial;
- undergoing other clinical trials;
- There was a history of alcoholism or drug dependence in the past two years;
- Other situations that the research physician thinks are not suitable to participate in this trial include but are not limited to: the subjects cannot follow the research protocol, which will bring potential safety hazards to the subjects, etc.
- Eligibility Criteria for Vascular Dementia group
- Early memory impairment with progressive deterioration, early prominent features of Parkinson's disease, and primary nervous system diseases (such as multiple sclerosis, encephalitis, etc.);
- There was no vascular lesion in neuroimaging examination;
- Other diseases that can explain cognitive impairment, such as brain tumor, multiple sclerosis, encephalitis, depression, poisoning, and systemic diseases and metabolic abnormalities that significantly affect cognitive function;
- Severe heart, brain, liver and hematopoiesis diseases, or other serious diseases affecting their survival;
- Drug or alcohol abuse / dependence within 3 months before participating in the trial;
- Pregnant and lactating women;
- Patients with severe mental disorders (perception disorders, thinking disorders);
- For known renal insufficiency, serum creatinine (CR) was higher than 221 umol/L in male and 177 umol/L in female;
- Patients with known liver dysfunction, alanine aminotransferase (ALT) > 3 times of normal value or with cirrhosis;
- The researchers believe that there are other situations that are not suitable for participating in this study.
- Eligibility Criteria for Idiopathic Membranous Nephropathy group
- Inclusion criteria for Idiopathic Membranous Nephropathy group
- The pathological diagnosis of renal biopsy was membranous nephropathy;
- The syndrome of TCM is phlegm and blood stasis;
- The urinary protein was more than 1G / D and < 8g / d;
- Blood pressure can be effectively controlled at ≤ 140 / 90mmHg;
- eGFR≥45ml/min；
- The age ranged from 18 to 70 years old;
- Sign informed consent.
- Exclusion criteria for Idiopathic Membranous Nephropathy group
- All kinds of secondary membranous nephropathy;
- Those who are taking hormone and / or immunosuppressive therapy;
- Women with pregnancy planning, pregnancy and lactation;
- Severe heart, brain, liver and hematopoiesis diseases, or other serious diseases affecting their survival;
- Participants in other clinical trials in recent 3 months.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Xiyuan hospital， China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
Yu Renhuan, Doctor, +86-13611196162, tezhongeyu@vip.sina.com
Fujian Provincial People's Hospital
Fuzhou, Fujian, 350004
Zhang Songfeng, Doctor, +86-13400561224, zsf881210@126.com
Affiliated Hospital of Jiangxi University of traditional Chinese Medicine
Nanchang, Jiangxi, 330006
Liu Zhongyong, Doctor, +86-1064089029, lzyongmail@163.com
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300151
Zhao Yingqiang, Doctor, 13920089969, zhaoyingqiang1000@126.com
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430060
Shi Heyuan, Doctor, +86-13971278693, shy79@hbtcm.edu.cn
Yichang Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 443003
Zhou Gang, +86-139865793257, 139865793257@126.com
The First Affiliated Hospital of Henan University of traditional Chinese Medicine
Zhengzhou, Henan, 450000
Duan Fei, Doctor, +86-18638601093, kybduanfei@126.com
About this study
This study is designed as a bayesian basket trial , which aims to evaluate the efficacy of Danzhu Fuyuan Granule in patients with Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy
- Being tested
- Danzhu Fuyuan Granule
- Keywords
- Danzhu Fuyuan Granule; Basket Trial
- Medical subject headings
- Angina, Stable, Dementia, Vascular, Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danzhu Fuyuan GranuleDrug
Danzhu Fuyuan Granules，2 times / day, 1 bag / time, one time in the morning and one time in the evening. It is recommended to add the same amount of boiling water as the particles to soak for 30 seconds, and then add 5 times boiling water to dissolve until completely dissolved.The treatment cycle of each arm: 8 weeks for Chronic Stable Angina, 6 months for Vascular Dementia and 6 months for Idiopathic Membranous Nephropathy.
| Study group | Role | What they receive |
|---|---|---|
| chronic stable angina | Experimental | Experimental: the patient who have the syndrome of intermingled phlegm and blood stasis with chronic stable angina will be treated by Danzhu Fuyuan Granule in addtion to routine care Receives: Drug: Danzhu Fuyuan Granule |
| Vascular Dementia | Experimental | Experimental: the patient who have the syndrome of intermingled phlegm and blood stasis with Vascular Dementia will be treated by Danzhu Fuyuan Granule in addtion to routine care Receives: Drug: Danzhu Fuyuan Granule |
| Idiopathic Membranous Nephropathy | Experimental | Experimental: the patient who have the syndrome of intermingled phlegm and blood stasis with Idiopathic Membranous Nephropathy will be treated by Danzhu Fuyuan Granule in addtion to routine care Receives: Drug: Danzhu Fuyuan Granule |
| Healthy population | No intervention | Comparator: Healthy population with no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint 1 for Chronic Stable Angina Group: the time to ST depression at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
It is suitable for Chronic Stable Angina group. The time to ST depression at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
Measured: 8 weeks
Primary endpoint 2 for Chronic Stable Angina group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina at the end of week 8 compared with baseline
It is suitable for Chronic Stable Angina group. Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina. The minimum score is 0 and the maximum score is 41. The higher the score is, the worse the outcomes is.
Measured: 8 weeks
Primary endpoint 1 for Vascular Dementia group: the score of Mini-mental State Examination at the end of month 6 compared with baseline
It is suitable for Vascular Dementia group. Mini Mental State Examination gives the 'mini-mental state' examination of cognitive function. This is a 5-minute bedside test that is useful as a screen and in assessing the degree of cognitive dysfunction in patients with diffuse brain disorders. The minimum score is 0 and the maximum score is 30. The higher the score is, the better the outcomes is.
Measured: 6 month
Primary endpoint 2 for Vascular Dementia group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Vascular Dementia at the end of month 6 compared with baseline
It is suitable for Vascular Dementia group Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Vascular Dementia is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Vascular Dementia. The minimum score is 0 and the maximum score is 46. The higher the score is, the worse the outcomes is.
Measured: 6 month
Primary endpoint 1 for Idiopathic Membranous Nephropathy group: level of the 24 hour urine protein quantification at the end of month 6 compared with baseline
It is suitable for Idiopathic Membranous Nephropathy group. level of the 24 hour urine protein quantification at the end of month 6 compared with baseline. To evaluate the drug efficiency by comparing date changes of 24 hour urine protein quantification before and 6 months after treatment by Danzhu Fuyuan Granule . The unit of 24 hour urine protein quantification values is described as g/24h
Measured: 6 months
Primary endpoint 2 for Idiopathic Membranous Nephropathy group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Idiopathic Membranous Nephropathy at the end of month 6 compared with baseline
It is suitable for Idiopathic Membranous Nephropathy group. Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis withIdiopathic Membranous Nephropathy is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Idiopathic Membranous Nephropathy. The minimum score is 0 and the maximum score is 42. The higher the score is, the worse the outcomes is.
Measured: 6 months
Secondary outcomes (12)
Duke treadmill score (DTS) at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
It is suitable for Chronic Stable Angina group. The Duke Treadmill Score was introduced in 1991 as a set of treadmill exercise findings that predict individual risk for death on the basis of a weighted combination of exercise duration, ST-segment depression, and the presence and nature of angina during testing. The score is calculated by subtracting 5 times the ST depression (in millimeters) and 4 times the angina score (no angina = 0, nonlimiting angina = 1, and test-limiting angina = 2) from minutes of exercise duration on the Modified Bruce protocol
Measured: 8 weeks
the score on Seattle Angina Questionnaire
It is suitable for Chronic Stable Angina group. The Seattle Angina Questionnaire (SAQ) is a self-administered, disease-specific measure for patients with Cornary Artery Disease that is valid, reproducible, and sensitive to clinical change.
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Measured: 8 weeks
Frequency of weekly angina episodes
It is suitable for Chronic Stable Angina group
Measured: 8 weeks
Angina pectoris severity classification according to Canadian Cardiovascular Society (CCS)
It is suitable for Chronic Stable Angina group
Measured: 8 weeks
Stopping or reducing rate of the Nitroglycerin Table
It issuitable for Chronic Stable Angina group
Measured: 8 weeks
Number of subjects with adverse events or severe adverse events
It is suitable for Chronic Stable Angina group
Measured: 8 weeks
Brain pulse index mearsured by Transcranial Doppler
It is suitable for Vascular Dementia group
Measured: 6 months
Arterial systolic blood flow velocity mearsured by Transcranial Doppler
It is suitable for Vascular Dementia group
Measured: 6 months
Mean flow velocity mearsured by Transcranial Doppler
It is suitable for Vascular Dementia group
Measured: 6 months
Level of serum creatinine
It is suitable for Idiopathic Membranous Nephropathy group.
Measured: 6 months
Level of blood urea nitrogen
It is sutitable for Idiopathic Membranous Nephropathy group.
Measured: 6 months
Glomerular filtration rate
It is for idiopathic membranous nephropathy group. It was calculated according to ckD-EPI 2009 formula
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study startAug 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable AnginaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jingqing Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jingqing Hu, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498962
- Sponsor's protocol ID
- 2019YFC1708500
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 5 Aug 2020
- 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial
- ClinicalTrials.gov ID
- NCT04498962
- Acronym / sponsor ID
- 2019YFC1708500
- Keywords
- Danzhu Fuyuan Granule; Basket Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jingqing HuUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 5 Aug 2020 (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 is designed as a bayesian basket trial , which aims to evaluate the efficacy of Danzhu Fuyuan Granule in patients with Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| chronic stable angina | Experimental | Drug: Danzhu Fuyuan GranuleExperimental: the patient who have the syndrome of intermingled phlegm and blood stasis with chronic stable angina will be treated by Danzhu Fuyuan Granule in addtion to routine care |
| Vascular Dementia | Experimental | Drug: Danzhu Fuyuan GranuleExperimental: the patient who have the syndrome of intermingled phlegm and blood stasis with Vascular Dementia will be treated by Danzhu Fuyuan Granule in addtion to routine care |
| Idiopathic Membranous Nephropathy | Experimental | Drug: Danzhu Fuyuan GranuleExperimental: the patient who have the syndrome of intermingled phlegm and blood stasis with Idiopathic Membranous Nephropathy will be treated by Danzhu Fuyuan Granule in addtion to routine care |
| Healthy population | No intervention | –Comparator: Healthy population with no treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient must be between the ages of 40 and 70 years
- Evidence of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrollment) of myocardial infarction or significant coronary artery disease with noninvasive or angiographic confirmation.
- Patient must match the diagnostic criteria for chronic stable angina set by Chinese Medical Association;
- The number of angina pectoris attacked in the past 3 months was more than 2 times per week
- Class I or Class II, Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System
Key exclusion criteria (36 listed)
- patients who are diagnosed with acute coronary syndrome (including acute myocardial infarction or unstable angina pectoris) occurred within 2 months before enrollment, or had undergone revascularization within 3 months before enrollment, or planned to undergo revascularization during the study period;
- Patients who are unable to complete Treadmill Exercise Test for various reasons, including absolute and relative contraindications;
- Severe primary diseases such as respiratory, blood system or malignant tumor, or known renal insufficiency (serum creatinine (CR) > 221 umol /L in male, or 177 umol / L in female);
- Patients with epilepsy who had bleeding tendency, history of cerebral hemorrhage, or needed anticonvulsant therapy;
- Patients with active liver disease, or accompanied with unexplained continuous increase of serum transaminase, or the detection value of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) is more than twice 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 |
|---|---|---|
| Danzhu Fuyuan GranuleDanzhu Fuyuan Granules，2 times / day, 1 bag / time, one time in the morning and one time in the evening. It is recommended to add the same amount of boiling water as the particles to soak for 30 seconds, and then add 5 times boiling water to dissolve until completely dissolved.The treatment cycle of each arm: 8 weeks for Chronic Stable Angina, 6 months for Vascular Dementia and 6 months for Idiopathic Membranous Nephropathy. | Drug | Idiopathic Membranous Nephropathy, Vascular Dementia, chronic stable angina |
Primary outcome
Primary endpoint 1 for Chronic Stable Angina Group: the time to ST depression at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
Time frame: 8 weeks
It is suitable for Chronic Stable Angina group. The time to ST depression at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
Primary endpoint 2 for Chronic Stable Angina group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina at the end of week 8 compared with baseline
Time frame: 8 weeks
It is suitable for Chronic Stable Angina group. Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Chronic Stable Angina. The minimum score is 0 and the maximum score is 41. The higher the score is, the worse the outcomes is.
Primary endpoint 1 for Vascular Dementia group: the score of Mini-mental State Examination at the end of month 6 compared with baseline
Time frame: 6 month
It is suitable for Vascular Dementia group. Mini Mental State Examination gives the 'mini-mental state' examination of cognitive function. This is a 5-minute bedside test that is useful as a screen and in assessing the degree of cognitive dysfunction in patients with diffuse brain disorders. The minimum score is 0 and the maximum score is 30. The higher the score is, the better the outcomes is.
Primary endpoint 2 for Vascular Dementia group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Vascular Dementia at the end of month 6 compared with baseline
Time frame: 6 month
It is suitable for Vascular Dementia group Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Vascular Dementia is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Vascular Dementia. The minimum score is 0 and the maximum score is 46. The higher the score is, the worse the outcomes is.
Primary endpoint 1 for Idiopathic Membranous Nephropathy group: level of the 24 hour urine protein quantification at the end of month 6 compared with baseline
Time frame: 6 months
It is suitable for Idiopathic Membranous Nephropathy group. level of the 24 hour urine protein quantification at the end of month 6 compared with baseline. To evaluate the drug efficiency by comparing date changes of 24 hour urine protein quantification before and 6 months after treatment by Danzhu Fuyuan Granule . The unit of 24 hour urine protein quantification values is described as g/24h
Primary endpoint 2 for Idiopathic Membranous Nephropathy group: the score on Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis with Idiopathic Membranous Nephropathy at the end of month 6 compared with baseline
Time frame: 6 months
It is suitable for Idiopathic Membranous Nephropathy group. Syndrome Questionnaire of Intermingled Phlegm and Blood Stasis withIdiopathic Membranous Nephropathy is a questionnarie to evaluate the severity of Syndrome of Intermingled Phlegm and Blood Stasis with Idiopathic Membranous Nephropathy. The minimum score is 0 and the maximum score is 42. The higher the score is, the worse the outcomes is.
12 secondary outcomes
Duke treadmill score (DTS) at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
Time frame: 8 weeks
the score on Seattle Angina Questionnaire
Time frame: 8 weeks
Frequency of weekly angina episodes
Time frame: 8 weeks
Angina pectoris severity classification according to Canadian Cardiovascular Society (CCS)
Time frame: 8 weeks
Stopping or reducing rate of the Nitroglycerin Table
Time frame: 8 weeks
Number of subjects with adverse events or severe adverse events
Time frame: 8 weeks
Brain pulse index mearsured by Transcranial Doppler
Time frame: 6 months
Arterial systolic blood flow velocity mearsured by Transcranial Doppler
Time frame: 6 months
Mean flow velocity mearsured by Transcranial Doppler
Time frame: 6 months
Level of serum creatinine
Time frame: 6 months
Level of blood urea nitrogen
Time frame: 6 months
Glomerular filtration rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Danzhu Fuyuan Granule in people with Chronic Stable Angina and Vascular Dementia, run by Jingqing Hu at 7 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 14 inclusion and 36 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 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 Xu Weiming, Doctor (86-1064089029, 15652608470@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint 1 for Chronic Stable Angina Group: the time to ST depression at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol (time frame: 8 weeks). The study lists 6 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 5 Aug 2020.