Last updated: March 24, 2022
Sponsor: Ruijin Hospital
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Diabetic Kidney Disease
Diabetic Foot Ulcers
Diabetic Neuropathy
Treatment
N/AClinical Study ID
NCT05295329
CDDP-202012
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Inclusion criteria: 1) age ≥ 18 and ≤ 75, male or female. 2) The microcirculationresistance index (IMR) of the left anterior descending coronary artery was ≥ 25.
- the diagnosis of type 2 diabetes or type 2 diabetes has been confirmed. 4) Combinedwith chest tightness, chest pain, palpitation, shortness of breath and other typicalor atypical symptoms of angina pectoris.
- Coronary angiography showed no severe epicardial coronary artery stenosis (diameterstenosis rate < 50%).
- The patient himself agreed to participate in this study.
Exclusion
Exclusion Criteria:
- Subjects that meet any of the following criteria will be excluded from this study:
- Severe cardiac insufficiency (LVEF<40%).
- Atrioventricular block and bronchial asthma above II°. (3) Malignant hypertension (SBP≥200 mmHg and/or DBP≥120 mmHg) or severe hypotension (SBP < 90 mmHg).
- Acute myocarditis, pericardial disease, valvular heart disease, primarycardiomyopathy, myocardial infarction, severe left ventricular hypertrophy (ventricular wall or septum thickness ≥13mm).
- Familial hypercholesterolemia. 6) Multiple arteritis. 7) Heart stenting wasperformed within 3 months. 8) Coronary artery bypass grafting. 9) History of strokewithin six months, history of intracranial diseases (aneurysm, arteriovenousmalformation), history of extensive trauma or surgery within six weeks; 10) Activebleeding, anemia of moderate or higher severity, including known thrombocytopenia orleukopenia, severe liver or kidney dysfunction, uncontrolled infection, immune systemand connective tissue diseases.
- those who are pregnant or lactation, or have the intention to give birth withinone year, or take effective contraceptive measures during their childbearing years.
- Abnormal liver function (serum ALT level exceeding 3.0 times the upper limit ofnormal) or abnormal kidney function (eGFR≤30%).
- Other respiratory, digestive, blood, infectious, immune, endocrine,neuropsychiatric, tumor and other diseases of clinical significance, which may causeserious risks to patients.
- Patients requiring warfarin or NOAC anticoagulation treatment are taking K channelopening agents and Traditional Chinese medicine preparations for promoting bloodcirculation and removing stasis to improve microcirculation.
- Allergic to contrast agent or CDDP; 16) Life expectancy less than one year; 17)Patients who participated in other TCM clinical studies within 12 months prior toinclusion.
Study Design
Total Participants: 120
Study Start date:
April 01, 2022
Estimated Completion Date:
December 30, 2022
Connect with a study center
Long March Hospital Affiliated to Naval Medical College
Shanghai, Shanghai
ChinaSite Not Available
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
Shanghai, Shanghai
ChinaSite Not Available
Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University
Shanghai, Shanghai
ChinaSite Not Available
Shanghai Minhang District Central Hospital
Shanghai, Shanghai
ChinaSite Not Available
Shanghai Ninth People's Hospital
Shanghai, Shanghai
ChinaSite Not Available
Shanghai Putuo District Central Hospital
Shanghai, Shanghai
ChinaSite Not Available
Shanghai Sixth People's Hospital
Shanghai, Shanghai
ChinaSite Not Available

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