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)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Heart Disease (CHD)
• Intervention / Treatment: Other: Placebo Comparator; Drug: Zhilong Huoxue Tongyu capsule

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Luzhou, Sichuan, China, 646000
      • Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator	Other: Placebo Comparator; Placebo Comparator
Experimental: Zhilong Huoxue Tongyu capsule	Drug: Zhilong Huoxue Tongyu capsule; Zhilong Huoxue Tongyu capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiang Hanmei

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Coronary Heart Disease
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Arteriosclerosis; Arterial Occlusive Diseases; Chest Pain; Blind Loop Syndrome; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: Clinical evidence based

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No