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Clinical Evidence Based Study on the Treatment of Stable Angina Pectoris/Myocardial Fibrosis with Mongolian Medicine Guanxin Shutong Capsules

Clinical Evidence Based Study on the Treatment of Stable Angina Pectoris/Myocardial Fibrosis with Mongolian Medicine Guanxin Shutong Capsules

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000315
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-08-29
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

stable angina pectoris/myocardial fibrosis

Interventions

Treatment group:Western medicine basic treatment (monoclonal antibodies, statins)+ Guanxin Shutong capsules (po, 3 capsules/tid), before meals Half an hour of service.
control group:Western medicine basic treatment (monoclonal antibodies, statins)+Guanxin Shutong capsule Simulant (po, 3 capsules/tid), before meals Half an hour of service.

Sponsors

International Mongolian Hospital of Inner Mongolia
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Consistent with the diagnosis of stable angina pectoris in coronary heart disease; (2) The diagnosis of Mongolian medicine is consistent with the diagnosis of Qisu type heart pain; (3) Canadian Cardiovascular Society (CCS) Angina Pectoris Classification I-III; (4) The detection of biomarkers such as PIINP, or cardiac ultrasound, cardiac magnetic resonance imaging, etc., suggests the presence of myocardial fibrosis; (5) Age range of 18-80 years old (including threshold), male or female not limited; (6) Voluntarily participate in clinical research and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Acute coronary syndrome (ACS) has occurred within the past month, currently accompanied by uncontrollable severe heart failure (NYHA classification>III), severe arrhythmia and other heart disease patients; (2) Screening for newly diagnosed cerebrovascular accidents within the previous 3 months; (3) Severe liver and kidney dysfunction (ALT>3 times normal, Scr>221 µ mol/L) and other serious diseases; (4) Pregnant or lactating women or those with pregnancy plans; Suspected or clearly allergic to research drugs; (5) Those who use any medication containing essentially the same ingredients as this Mongolian medicine within 2 weeks.

Design outcomes

Primary

MeasureTime frame
Angina symptom score: Improvement in angina symptom score compared to baseline after 12 weeks of treatment.;

Secondary

MeasureTime frame
Ultrasound examination of cardiac function and carotid intima-media thickness: at 0d, 4, and 12 weeks, performed by the same qualified physician for ultrasound examination Teacher applies ultrasound three-dimensional speckle tracking imaging technology to evaluate changes in cardiac function and detect carotid intima-media thickness;Biomarkers of myocardial fibrosis: type III collagen N-terminal peptide (PIIINP), type I procollagen carboxy terminal peptide (PICP), type I Collagen pyridine cross-linked terminal peptide (ICTP), laminin (LN), type IV collagen (C-IV), hyaluronic acid (HA), etc;The incidence of composite cardiovascular events (myocardial infarction, heart failure, cerebral infarction, cardiogenic death, all-cause death); test Observation during the period and follow-up period;The total effective rate (significant+effective) of the changes in Mongolian medicine syndrome score compared to baseline in the experimental group and control group of Qisu type angina pectoris syndrome score in stable coronary heart disease treated with Mongolian medicine after 1, 4, and 12 weeks of treatment;;Laboratory testing: Fasting venous blood samples were collected at 0d, 4, and 12 weeks to detect myocardial injury markers (cTnT, CK-MB), 6 blood lipid parameters (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein a, apolipoprotein b), and 4 coagulation parameters+D-dimer;;159/10000 ???? 159/10000 Real time translation system biological indicators: Biomarkers: Blood lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein lipids, apolipoprotein a, apolipoprotein b), type III collagen N-terminal peptide (P ? NP), type I procollagen carboxy terminal peptide (I CP), type I collagen pyridine cross-linked terminal peptide (I CTP), laminin (LN), type IV collagen (IV-C), hya;Analysis of drug effects on the improvement of CCS classification in stable angina compar

Countries

China

Contacts

Public ContactTe Mu Qi Le

International Mongolian Hospital of Inner Mongolia

tmqyx@163.com13947119993

Outcome results

None listed

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