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Clinical efficacy study on the protective effect of Yixin Decoction pretreatment on myocardial ischemia-reperfusion injury of qi deficiency and blood stasis type

Clinical efficacy study on the protective effect of Yixin Decoction pretreatment on myocardial ischemia-reperfusion injury of qi deficiency and blood stasis type

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000644
Enrollment
Unknown
Registered
2025-04-02
Start date
2025-03-26
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

myocardial ischemia reperfusion injury

Interventions

Treatment group B:On the basis of standardised western medical treatment, Yixinfang granules were given preoperatively and postoperatively.
control group:Pre- and postoperative placebo (with 10% Yixinfang granules) was given on the basis of standard Western medicine regimens.
Treatment group A:On the basis of standardised western medicine treatment, placebo was given preoperatively, and Yixinfang granules were given postoperatively.

Sponsors

Shuguang Hospital affiliated with Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-85 years old gender unrestricted; 2) STEMI patients suitable for coronary artery stent implantation; 3) Patients diagnosed with Qi deficiency and blood stasis syndrome in Traditional Chinese Medicine; 4) Voluntary participants who have signed the informed consent form; 5) Patients who have not received Yixin Formula treatment before. All five conditions must be met for inclusion in the clinical study.

Exclusion criteria

Exclusion criteria: 1)Patients with cardiogenic shock 2) patients with combined severe pulmonary insufficiency; 3) patients with combined severe primary diseases of liver brain kidney and haematopoietic system and psychiatric patients; 4) People with controversial identification and typing in traditional Chinese medicine; 5)Pregnant or preparing for pregnancy breastfeeding women; 6) Known allergy to such drugs and those with severe allergies; 7)Patients who have participated in other clinical drug trials within the last 3 months; 8)Inability or unwillingness to sign the informed consent form. All of the above eight No can be included in the clinical study.

Design outcomes

Primary

MeasureTime frame
Efficacy of TCM symptoms;Clinical endpoint events;

Secondary

MeasureTime frame
Cardiac enzymes;echocardiographic parameters;Plasma type B brain natriuretic peptide;electrocardiogram;TNF-a;superoxide dismutase;Cardiac troponin I;Evaluation of coronary blood flow by TIMI flow grading method;Amino-terminal brain natriuretic peptide precursor;S1P;IL-6;IL-1;nitric oxide;

Countries

China

Contacts

Public ContactRong Jingfeng

Shuguang Hospital affiliated with Shanghai University of TCM

anastacia@126.com+86 186 1686 5052

Outcome results

None listed

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