The Effect of Danzhu Fuyuan Granule as Adjunctive Therapy for Chronic Stable Angina, Vascular Dementia and Idiopathic Membranous Nephropathy: A Bayesian Basket Trial
1 other identifier
interventional
240
1 country
7
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedFirst Posted
Study publicly available on registry
August 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 5, 2020
July 1, 2020
10 months
July 21, 2020
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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.
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.
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.
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
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.
6 months
Secondary Outcomes (12)
Duke treadmill score (DTS) at the end of week 8 compared with baseline on submaximal exercise Modified Bruce Protocol
8 weeks
the score on Seattle Angina Questionnaire
8 weeks
Frequency of weekly angina episodes
8 weeks
Angina pectoris severity classification according to Canadian Cardiovascular Society (CCS)
8 weeks
Stopping or reducing rate of the Nitroglycerin Table
8 weeks
- +7 more secondary outcomes
Study Arms (4)
chronic stable angina
EXPERIMENTALExperimental: 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
EXPERIMENTALExperimental: 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
EXPERIMENTALExperimental: 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 INTERVENTIONComparator: Healthy population with no treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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;
- 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
- 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;
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jingqing Hulead
Study Sites (7)
Xiyuan hospital， China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091, China
Fujian Provincial People's Hospital
Fuzhou, Fujian, 350004, China
The First Affiliated Hospital of Henan University of traditional Chinese Medicine
Zhengzhou, Henan, 450000, China
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 430060, China
Yichang Hospital of Traditional Chinese Medicine
Wuhan, Hubei, 443003, China
Affiliated Hospital of Jiangxi University of traditional Chinese Medicine
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300151, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Institute of Basic Theory of Traditional Chinese Medicine
Study Record Dates
First Submitted
July 21, 2020
First Posted
August 5, 2020
Study Start
August 1, 2020
Primary Completion
June 1, 2021
Study Completion
December 1, 2021
Last Updated
August 5, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share