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A randomized double-blind placebo-controlled study of Shene-Xiaozheng formula in the treatment of elderly patients with unstable angina

A randomized double-blind placebo-controlled study of Shene-Xiaozheng formula in the treatment of elderly patients with unstable angina

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001504
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

unstable angina

Interventions

control group:Placebo twice a day one bag in the morning and one bag in the evening taken with water and the course of treatment is 4 weeks.
experimental group:Shene Xiaozheng Formula twice a day one bag in the morning and one bag in the evening taken with water and the course of treatment is 4 weeks.

Sponsors

Guanganmen Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Meeting the western medicine diagnostic criteria of unstable angina pectoris and the TCM diagnostic criteria of chest stuffiness heartache deficiency and blood stasis; 2) Age 60-80 years old; 3) Informed the research content and signed the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1) Patients with a history of infection fever trauma burn or surgery within the past 1 month severe hematological diseases malignant tumors within 3 months after surgery or undergoing radiotherapy and chemotherapy or severe mental disorders; 2) valvular heart disease (severe lesions in one or more valves); 3) poorly controlled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg) with active medication; Severe diabetic complications; Severe heart failure (ejection fraction 900 pg/ml for age 60-75 years > 1800 pg/ml for age 75-80 years); Severe arrhythmia such as paroxysmal atrial fibrillation atrial flutter and paroxysmal ventricular tachycardia complete left bundle branch block ? degree atrioventricular block type 2 ? degree atrioventricular block sick sinus syndrome pacemaker application; Alanine aminotransferase and (or) aspartate aminotransferase > 2 times the upper limit of normal creatinine > 1.5 times the upper limit of normal; 4) cerebrovascular accident or acute gastrointestinal bleeding in the past 6 months; 5) Patients with chest pain caused by non-coronary artery disease such as aortic dissection other congenital heart disease severe neurosis climacteric syndrome hyperthyroidism cervical spondylosis stomach and esophageal reflux were excluded; 6) patients with acute exacerbation of chronic obstructive pulmonary disease or cor pulmonale or respiratory failure with abnormal blood gas analysis; 7) suspected allergy to study drug or any component thereof; 8) enrolled in other clinical trials within 3 months; 9) with a history of alcohol or drug abuse; 10) have used antibiotics or participated in any probiotic prebiotic or laxative study in the 3 months before the study; 11) who were judged by the investigator to be ineligible for the study.

Design outcomes

Primary

MeasureTime frame
Curative effect of angina pectoris symptoms (total effective rate);

Secondary

MeasureTime frame
fasting total cholesterol;Reduction rate of nitroglycerin;Symptoms of angina pectoris;Targeted lipidomics;fasting triglycerides;Score of traditional Chinese medicine syndrome scale;sdLDL-C;fasting low-density lipoprotein cholesterol;Electrocardiogram;Serum non-targeted metabolomics;lipoprotein a;fasting high-density lipoprotein cholesterol;

Countries

China

Contacts

Public ContactWu Min

Guanganmen Hospital China Academy of Chinese Medical Sciences

wumin19762000@126.com13671206090

Outcome results

None listed

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