Clinical Evidence Based and TCM Phenotype Group Study of Zhilong Huoxue Tongyu Capsule in the Treatment of Stable Angina Pectoris of Coronary Heart Disease (Qi Deficiency and Blood Stasis Syndrome)

Phase 2

• Conditions: Coronary Heart Disease (CHD)
• Interventions: Drug: Zhilong Huoxue Tongyu capsule; Other: Placebo Comparator

• Registration Number: NCT06709638
• Lead Sponsor: Jiang Hanmei

Brief Summary

This study intends to prove the clinical effect of Zhidong Huoxue Tongyu capsule in the treatment of stable angina pectoris with qi deficiency and blood stasis syndrome from the perspective of TCM syndrome differentiation and treatment. To detect metabolites in serum, urine and feces of patients with stable angina pectoris syndrome of qi deficiency and blood stasis by LC-MS metabolomics technology. Compared with normal control group, differential metabolites were found to provide molecular basis for the diagnosis of the disease. Metabolomics technology based on LC-MS was used to analyze the metabolites in serum, urine and feces before and after the treatment of Zhulong Huoxue Tongyu capsule in stable angina pectoris with qi deficiency and blood stasis syndrome. To provide laboratory evidence for Zhilong Huoxue Tongyu capsule in the treatment of stable angina pectoris with qi deficiency and blood stasis syndrome.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-01
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Healthy control group: (1) no clinical symptoms, heart color Doppler ultrasound, CTA showed no coronary heart disease and other organic heart disease; (2) Age: over 40 years old; (3) Matched with the basic information of gender, culture and education of the treatment group and the control group; (4) Voluntarily sign informed consent.

Treatment and control groups: (1) Western medicine meets the diagnostic criteria of stable angina pectoris of coronary heart disease, and there is no change in the frequency, duration, trigger or relief mode of angina pectoris attacks in the past 60 days. There was no evidence of recent myocardial injury (normal serum cardiac markers troponin T or troponin I, and no abnormal resting electrocardiogram showing significant ST-segment elevation) and angina grade I-IV. Coronary angiography or coronary CTA within 1 year: 50%< Degree of coronary artery stenosis < 75% (including left anterior descending artery, right coronary artery, left circumflex artery, and left main artery) or 50%< Degree of coronary branch vessel stenosis < 100% lesions (except main coronary arteries, such as diagonal branches). (2) consistent with TCM syndrome of Qi deficiency and blood stasis; (3) age ≥40 years old, gender is not limited; (4) Those who voluntarily sign informed consent after communication.

Exclusion Criteria

• Healthy people: (1) liver dysfunction, renal dysfunction; (2) Participating in other clinical investigators within the past two months; (3) pregnant women, those who plan to be pregnant or lactating women.

Patients with stable angina pectoris syndrome of qi deficiency and blood stasis: (1) Those who did not meet the inclusion criteria; (2) complicated with severe hepatic and renal dysfunction; (3) pregnant and lactating women, patients with allergic constitution and a history of mental illness; (4) Acute myocardial infarction, congenital heart disease; Valvular heart disease; Myocardial infarction within the last 2 months; Patients who already have pacemakers and coronary and other stents that are not suitable for MRI materials; Malignant tumors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zhilong Huoxue Tongyu capsule	Zhilong Huoxue Tongyu capsule	-
Placebo Comparator	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
TCM syndrome integral scale	From enrollment to 60 days after treatment
CCS angina grading	From enrollment to 60 days after treatment
The number of angina attacks	From enrollment to 60 days after treatment
Nitroglycerin usage	From enrollment to 60 days after treatment

Trial Locations

Locations (1)

Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University; 🇨🇳 Luzhou, Sichuan, China