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Qi Shen Yi Qi Dropping Pill to Reduce Residual Inflammation in Patients with ACS: a Randomized Double-Blind Placebo-Controlled Trial

The Effect and Mechanism of Qi Shen Yi Qi Dropping Pill in Inhibiting the Coagulation-Inflammation Crosstalk to Mitigate the Residual Inflammation in Acute Coronary Syndrome Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000403
Enrollment
Unknown
Registered
2025-02-24
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Acute Coronary Syndrome (ACS)

Interventions

Experimental Group:Qi Shen Yi Qi Dropping Pill
Control Group:Placebo

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Meets the diagnostic criteria for Acute Coronary Syndrome (ACS). (2)Aged between 18 and 80 years. (3)IL-1ß levels greater than 3 pg/mL. (4)The patient and their family have agreed to the treatment plan and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with severe structural heart disease; (2) Patients with severe underlying diseases such as liver or renal system disorders, including those with liver function (ALT or AST) greater than 1.5 times the upper limit of normal, or renal dysfunction; (3) Patients with other systemic diseases that affect coagulation or immune function (e.g., hematologic disorders, autoimmune diseases, malignancies, etc.); (4) Patients who have had an acute infection or acute exacerbation of other diseases within the past two weeks, such as hypertensive emergencies; (5) Pregnant or lactating women, or women who may become pregnant during the study period; (6) Patients with a history of allergic reactions or hypersensitivity to any components of the investigational drug; (7) Patients who have taken other traditional Chinese medicines or Chinese patent medicines in the past three months, or those who have used medications that may affect coagulation or immune function; (8) Patients who have received other investigational drugs within three months prior to the administration of the study drug, or within five half-lives of other investigational drugs (whichever is longer); (9) Patients with psychiatric, psychological, or other conditions that are incompatible with the completion of the study; (10) Patients who are deemed unsuitable for clinical trials for other reasons as determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Interleukin-1 beta (IL-1ß);hs-CRP;

Secondary

MeasureTime frame
Monocyte subtypes;Seattle Angina Questionnaire (SAQ);Inflammatory Hematological Ratio;

Countries

China

Contacts

Public ContactLi Xianlun

China-Japan Friendship Hospital

leexianlun@163.com13910812495

Outcome results

None listed

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