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

NCT ID: NCT05295329

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-12-30

Brief 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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test group

Take compound salvia miltiorrhiza dropping pills

Group Type: EXPERIMENTAL

Compound Danshen Dropping Pills

Intervention Type: DRUG

use Compound Danshen Dropping Pills

placebo group

Take a placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

use placebo

Interventions

Compound Danshen Dropping Pills

use Compound Danshen Dropping Pills

Intervention Type: DRUG

Placebo

use placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

3) the diagnosis of type 2 diabetes or type 2 diabetes has been confirmed. 4) Combined with chest tightness, chest pain, palpitation, shortness of breath and other typical or atypical symptoms of angina pectoris.

5) Coronary angiography showed no severe epicardial coronary artery stenosis (diameter stenosis rate < 50%).

6) The patient himself agreed to participate in this study.

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).

4) Acute myocarditis, pericardial disease, valvular heart disease, primary cardiomyopathy, myocardial infarction, severe left ventricular hypertrophy (ventricular wall or septum thickness ≥13mm).

5) Familial hypercholesterolemia. 6) Multiple arteritis. 7) Heart stenting was performed within 3 months. 8) Coronary artery bypass grafting. 9) History of stroke within six months, history of intracranial diseases (aneurysm, arteriovenous malformation), history of extensive trauma or surgery within six weeks; 10) Active bleeding, anemia of moderate or higher severity, including known thrombocytopenia or leukopenia, severe liver or kidney dysfunction, uncontrolled infection, immune system and connective tissue diseases.

11) those who are pregnant or lactation, or have the intention to give birth within one year, or take effective contraceptive measures during their childbearing years.

12) Abnormal liver function (serum ALT level exceeding 3.0 times the upper limit of normal) or abnormal kidney function (eGFR≤30%).

13) Other respiratory, digestive, blood, infectious, immune, endocrine, neuropsychiatric, tumor and other diseases of clinical significance, which may cause serious risks to patients.

14) Patients requiring warfarin or NOAC anticoagulation treatment are taking K channel opening agents and Traditional Chinese medicine preparations for promoting blood circulation and removing stasis to improve microcirculation.

15) 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 to inclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Long March Hospital Affiliated to Naval Medical College

Shanghai, Shanghai Municipality, China

Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Shanghai Minhang District Central Hospital

Shanghai, Shanghai Municipality, China

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Shanghai Putuo District Central Hospital

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

ruiyan zhang

Role: CONTACT

zhangruiyan@263.net

13601911729

Facility Contacts

chun liang

Role: primary

ruiyan zhang

Role: primary

wei hu

Role: primary

junfeng zhang

Role: primary

zongjun liu

Role: primary

chengxin shen

Role: primary

Other Identifiers

CDDP-202012

Identifier Type: -

Identifier Source: org_study_id