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A Randomized Controlled Trial:Using Metabolomics to Investigate the Mechanisim of Shexiang Tongxin Dropping Pill for the Treatment of Stable Angina Pectoris (Qi Deficiency and Blood Stasis Syndrome)

A Randomized Controlled Trial:Using Metabolomics to Investigate the Mechanisim of Shexiang Tongxin Dropping Pill for the Treatment of Stable Angina Pectoris (Qi Deficiency and Blood Stasis Syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073603
Enrollment
Unknown
Registered
2023-07-16
Start date
2023-07-16
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

Coronary heart disease in stable angina pectoris

Interventions

Shexiang Tongxin Dropping Pill(STDP) Group:Shexiang Tongxin Dropping Pill+conventional medicines

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai , China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria for stable angina pectoris of coronary heart disease;With reference to the Guidelines for the Diagnosis and Treatment of Stable Coronary Heart Disease issued by the Chinese Medical Association Cardiovascular Disease Branch in 2018, the relevant diagnostic criteria were formulated.Diagnostic criteria for coronary heart disease (any 1 of the following must be met).(1) Coronary angiography shows that the diameter of the lumen of at least one major branch of the coronary artery is narrowed by more than 50%;(2) More than one year after percutaneous coronary intervention (PCI) or/and coronary artery bypass graft (CABG). Diagnostic criteria for stable angina pectoris:(1) There is no significant change in the degree, frequency, nature and triggering factors of angina pectoris in the past 60 days;(2) Negative TnI, myoglobin, myocardial enzymes, hs-CRP, and ECG, except acute coronary syndrome. 2) Meet the Chinese medicine diagnostic criteria for qi deficiency and blood stasis;Diagnostic criteria of Chinese medicine:refer to the "Guiding Principles for Clinical Research of New Chinese Medicines" of the Ministry of Health in 2002 for the diagnostic criteria of Qi deficiency and blood stasis.Primary symptoms: chest pain, chest tightness.Secondary symptoms: palpitation, shortness of breath, fatigue, purple color.Tongue and pulse: pale purple tongue, weak and astringent pulse.Diagnosis can be made if there is one of the main symptoms of chest pain and chest tightness, and two of the other symptoms are supported by the tongue and pulse. 3) Patients with two or more episodes of angina pectoris per week; 4) Canadian Cardiovascular Society (CCS) angina class I-III; 5) Age 18-80 years old (including 18 and 80 years old); 6) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women; 2) Patients with severe cardiovascular diseases such as intractable heart failure, cardiogenic shock, and severe heart valve disease; 3) Patients with chest pain caused by pathologies other than coronary artery disease, such as psychosis, severe neurosis, hyperthyroidism, bile heart syndrome, gastric and esophageal reflux, aortic coarctation, and so on; 4) Combined uncontrolled class III hypertension (systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg) and severe cardiac arrhythmia; 5) Patients with severe respiratory diseases such as severe pulmonary insufficiency (PaO2 <60mmHg); 6) Patients with severe liver and kidney diseases such as liver insufficiency (alanine aminotransferase or glutamic oxalate aminotransferase level more than two times higher than the normal value) and renal insufficiency (creatinine level more than two times higher than the normal value); 7) Patients with other serious diseases or conditions such as malignant tumors, severe anemia, and severe renal artery stenosis; 8) Patients with allergies, or allergies to various drugs and foods, or those who are known to be allergic to the research drug (including its ingredients); 9) Those who have participated in other drug clinical studies within the last 2 months; 10) Those who have recent infections, traumas, etc. that the researchers judged as not being able to participate in the study.

Design outcomes

Primary

MeasureTime frame
Seattle Angina Scale Score;

Secondary

MeasureTime frame
UCG;EKG;Angina Symptom Score;Angina Symptom Score;TCM symptom score;Blood lipid;Blood sugar;hs-CRP;NO;SOD;Incidence of cardiovascular event;

Countries

China

Contacts

Public ContactXiaolong Wang

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

wxlqy0214@163.com+86 135 0199 1450

Outcome results

None listed

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