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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

120

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline

Completed

Started Apr 2022

Shorter than P25 for not_applicable diabetes

Geographic Reach

1 country

7 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

March 1, 2022

Completed

24 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed

7 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed

Last Updated

March 25, 2022

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

March 1, 2022

Last Update Submit

March 24, 2022

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

IMR improvementcompared with baseline.
Proportion of subjects with ≥ 20% reduction in IMR after 3 months of medication
3 months

Study Arms (2)

Test group

EXPERIMENTAL

Take compound salvia miltiorrhiza dropping pills

Drug: Compound Danshen Dropping Pills

placebo group

PLACEBO COMPARATOR

Take a placebo

Drug: Placebo

Interventions

Compound Danshen Dropping PillsDRUG

use Compound Danshen Dropping Pills

Test group

PlaceboDRUG

use placebo

placebo group

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\) 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.
\) Coronary angiography showed no severe epicardial coronary artery stenosis (diameter stenosis rate \< 50%).
\) The patient himself agreed to participate in this study.

You may not qualify if:

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, primary cardiomyopathy, myocardial infarction, severe left ventricular hypertrophy (ventricular wall or septum thickness ≥13mm).
\) 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.
\) 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.
\) Abnormal liver function (serum ALT level exceeding 3.0 times the upper limit of normal) or abnormal kidney function (eGFR≤30%).
\) Other respiratory, digestive, blood, infectious, immune, endocrine, neuropsychiatric, tumor and other diseases of clinical significance, which may cause serious risks to patients.
\) 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.

Contact the study team to confirm eligibility.