A Randomized Controlled Trial for Gualou Danshen Granules in the Treatment of Unstable Angina Pectoris Patients with Phlegm-Blood Stasis Syndrome

Phase 2

• Conditions: nstable angina pectoris

• Registration Number: ITMCTR2000003201
• Lead Sponsor: Guanganmen Hospital, Chinese Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Conforms to the diagnostic criteria of unstable angina pectoris in the guidelines for the diagnosis and treatment of unstable angina pectoris and non-st-segment elevation myocardial infarction published by the Chinese society of cardiovascular diseases. The diagnostic criteria of TCM syndromes are consistent with phlegm and blood stasis obstruction syndrome;
(2) Patients with coronary heart disease confirmed by coronary angiography (1 or more major coronary artery stenosis degree >=50%);
(3) Aged 35-75 years old;
(4) Participate voluntarily in this clinical study and sign the informed consent form. Subjects should insist on taking the medicine for 4 weeks, complete the scale and test before and after treatment. A fixed contact way to complete the follow-up work is also requisite.

Exclusion Criteria

1. Those who have been confirmed to have chest pain caused by stable angina pectoris, acute myocardial infarction, aortic dissection, other congenital heart disease, valvular disease, severe neurosis, etc .;
2. Poorly controlled hypertension (systolic blood pressure >=160mmHg or diastolic blood pressure >=100mmHg), severe cardiopulmonary dysfunction (heart function level III or IV);
3. Chest tightness and chest pain caused by arrhythmia;
4. Acute stage of cerebral infarction;
5. Patients with severe primary diseases such as liver, kidney, hematopoietic system, liver function ALT or AST value> 1.5 times the upper limit of normal value, those with abnormal renal function;
6. Those with acute infection within the last 2 weeks;
7. Combine with other serious diseases who must be treated (such as blood diseases, tumors, etc.);
8. Diabetes does not meet the general control standards, or more serious diabetes complications occur;
9. Women who are pregnant or breastfeeding;
10. Those with allergies or allergies to the test drug ingredients.
In addition:
1) patients who are participating in other clinical trials or patients whose clinical trials are finished less than one month;
2) Researchers believe that other reasons are not suitable for clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phlegm-Blood Stasis Syndrome scoring criteria;Seattle Angina Scale score;Coronary Heart Disease Clinical Symptom Grading Scale;