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)

NCT06709638 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: Clinical evidence based
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease (CHD)

Keywords

Coronary Heart Disease

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Zhilong Huoxue Tongyu capsule

EXPERIMENTAL

Drug: Zhilong Huoxue Tongyu capsule

Placebo Comparator

PLACEBO COMPARATOR

Other: Placebo Comparator

Interventions

Placebo Comparator OTHER

Placebo Comparator

Placebo Comparator

Zhilong Huoxue Tongyu capsule DRUG

Zhilong Huoxue Tongyu capsule

Zhilong Huoxue Tongyu capsule

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiang Hanmei: lead

Study Sites (1)

Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Grade 2023 master candidate of Southwest Medical University

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)