Effect of Compound Danshen Dripping Pills on Diabetic Patients With Coronary Microcirculation Disturbance

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/A

Clinical Study ID

NCT05295329
CDDP-202012
  • Ages 18-75
  • All Genders

Study Summary

Most patients with diabetes complicated with microvascular circulation disorder have normal coronary angiography but still suffer from chest tightness, chest pain and so on. Early dysfunction of coronary microcirculation is an important reason for it. It is also an important factor leading to poor prognosis of patients with diabetes. For these patients, there are still no drugs to improve microcirculation disorders. Compound Danshen dropping pills have the effects of anti-oxidation, anti-inflammatory, protecting endothelium, inhibiting the formation of atherosclerotic plaque and intimal hyperplasia, reducing oxygen consumption, improving energy metabolism, protecting cardiomyocytes, inhibiting platelet adhesion and aggregation, and improving microcirculation. However, there is a lack of clinical evidence that compound Danshen dripping pills can improve the cardiac microcirculation disturbance in diabetic patients with microangio angina. Therefore, the aim of this study was to observe the effect of Compound Danshen Dripping Pills on coronary microcirculation disturbance in diabetic patients.

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.
  1. 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.
  2. Coronary angiography showed no severe epicardial coronary artery stenosis (diameterstenosis rate < 50%).
  3. 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:
  1. Severe cardiac insufficiency (LVEF<40%).
  2. Atrioventricular block and bronchial asthma above II°. (3) Malignant hypertension (SBP≥200 mmHg and/or DBP≥120 mmHg) or severe hypotension (SBP < 90 mmHg).
  1. Acute myocarditis, pericardial disease, valvular heart disease, primarycardiomyopathy, myocardial infarction, severe left ventricular hypertrophy (ventricular wall or septum thickness ≥13mm).
  2. 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.
  3. those who are pregnant or lactation, or have the intention to give birth withinone year, or take effective contraceptive measures during their childbearing years.
  4. Abnormal liver function (serum ALT level exceeding 3.0 times the upper limit ofnormal) or abnormal kidney function (eGFR≤30%).
  5. Other respiratory, digestive, blood, infectious, immune, endocrine,neuropsychiatric, tumor and other diseases of clinical significance, which may causeserious risks to patients.
  6. 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.
  7. 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
    China

    Site Not Available

  • Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University

    Shanghai, Shanghai
    China

    Site Not Available

  • Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Minhang District Central Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Ninth People's Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Putuo District Central Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.