Clinical trial NCT06709638: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Coronary Heart Disease (CHD)
Keywords: Coronary Heart Disease
Lead sponsor: Southwest Medical University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 230
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: TCM syndrome integral scale
timeFrame: From enrollment to 60 days after treatment
measure: CCS angina grading
timeFrame: From enrollment to 60 days after treatment
measure: The number of angina attacks
timeFrame: From enrollment to 60 days after treatment
measure: Nitroglycerin usage
timeFrame: From enrollment to 60 days after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Luzhou
country: China
facility: Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University
state: Sichuan
Study officials:
References: