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Randomized Double-blind, Placebo-controlled, Single-center Clinical Study on the Efficacy and Safety of Tianxiangan in the Treatment of Stable Angina Pectoris of Coronary Heart Disease with Qi Deficiency and Blood Stasis Syndrome - A Project for Integrated Traditional Chinese and Western Medicine Clinical Collaboration in Major and Difficult Diseases

Randomized Double-blind, Placebo-controlled, Single-center Clinical Study on the Efficacy and Safety of Tianxiangan in the Treatment of Stable Angina Pectoris of Coronary Heart Disease with Qi Deficiency and Blood Stasis Syndrome - A Project for Integrated Traditional Chinese and Western Medicine Clinical Collaboration in Major and Difficult Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002473
Enrollment
Unknown
Registered
2025-12-24
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable angina pectoris in coronary heart disease

Interventions

experimental group:On the basis of western medicine treatment in the control group, Tianxiangdan Granules were added. Tianxiangdan Granules, 1 bag each time, twice a day, taken orally.
control group:The standard secondary preventive medication treatment plan for stable angina pectoris in coronary heart disease includes antiplatelet aggregation with aspirin enteric-coated tablets, 10
lipid regulation and plaque stabilization with atorvastatin calcium tablets, 20mg orally once every night
coronary artery dilation with isosorbide mononitrate sustained-release tablets, 40mg orally once daily
sublingual nitroglycerin when necessary
if the patient has comorbid hypertension or diabetes, antihypertensive and hypoglycemic drugs should be used reasonably according to the patients condition.

Sponsors

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, No. 116, Huanghe Road, Urumqi City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the inclusion criteria for stable angina pectoris of coronary heart disease and have stable condition for = 1 month; (2) Those who meet the diagnostic criteria for qi deficiency and blood stasis syndrome in traditional Chinese medicine; (3) Aged 18-80 years, regardless of gender; (4) Discontinue taking other Chinese herbal medicines and proprietary Chinese medicines during the clinical trial phase; (5) Sign the informed consent form and have good compliance.

Exclusion criteria

Exclusion criteria: (1) Patients with heart failure who have New York Heart Association (NYHA) class IV heart function or a left ventricular ejection fraction = 40%; (2) Patients who have received or need to receive coronary stenting; (3) Patients with multi-vessel disease who require coronary artery bypass grafting; (4) Patients with contraindications to coronary CTA examination; (5) Patients with severe arrhythmias; (6) Patients with mental disorders who cannot voluntarily cooperate with treatment; (7) Patients with malignant tumors or those complicated with acute infections, trauma, or active rheumatic diseases; (8) Pregnant or lactating women, or women planning to become pregnant. (9) Patients who do not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
Seattle Angina Scale;

Secondary

MeasureTime frame
TCM Syndrome Score;TC,TG,LDL-C,HDL-C;ET-1 ,NO;hsCRP ,TNF-a ,IL-6;

Countries

China

Contacts

Public ContactAn Dongqing

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

326468701@qq.com18099678099

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026