The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dem… (NCT04498962) | Clinical Trial Compass
UnknownNot Applicable
The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial
China240 participantsStarted 2020-08
Plain-language 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
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 8 weeks
2
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
Timeframe: 8 weeks
3
Primary endpoint 1 for Vascular Dementia group: the score of Mini-mental State Examination at the end of month 6 compared with baseline
Timeframe: 6 month
4
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
Timeframe: 6 month
5
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
Timeframe: 6 months
6
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
. 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;
Exclusion criteria
. 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;
. patients can't stopped taking long-acting nitrates during the clinical trial;