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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

Registration number：

ITMCTR2025000403

Date of Last Refreshed on：

2025-02-24

Date of Registration：

2025-02-24

Registration Status：

Prospective registration

Public title：

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

English Acronym：

Scientific title：

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

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Wu Song

Study leader：

Li Xianlun

Applicant telephone：

15250013798

Study leader's telephone：

13910812495

Applicant Fax：

Study leader's fax：

Applicant E-mail：

b2024023025@student.pumc.edu.cn

Study leader's E-mail：

leexianlun@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.2 East Yinghua Road Chaoyang District Beijing

Study leader's address：

No.2 East Yinghua Road Chaoyang District Beijing

Applicant postcode：

100029

Study leader's postcode：

10029

Applicant's institution：

China-Japan Friendship Hospital

Approved by ethic committee：

Approved No. of ethic committee：

2024-KY-383

Approved file of Ethical Committee：

View

Name of the ethic committee：

The Clinical Research Ethics Board at China‑Japan Friendship Hospital

Date of approved by ethic committee：

2024/11/22 0:00:00

Contact Name of the ethic committee：

Yan Xu

Contact Address of the ethic committee：

No.2 East Yinghua Road Chaoyang District Beijing

Contact phone of the ethic committee：

010-8420 6086

Contact email of the ethic committee：

ZRYHYYGCPEC@126.com

Primary sponsor：

China-Japan Friendship Hospital

Primary sponsor's address：

China-Japan Friendship Hospital

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

China-Japan Friendship Hospital

Address：

No.2 East Yinghua Road Chaoyang District Beijing

Source(s) of funding：

China Heart House-Chinese Cardiovascular Association-2024 TCM fund（2024-CCA-TCM-040）

Target disease：

Acute Coronary Syndrome (ACS)

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

This study investigates the clinical efficacy of Qishen Yiqi Dropping Pills in reducing residual inflammation in ACS patients through a single-center randomized placebo-controlled double-blind clinical trial and evaluates its safety profile

Description for medicine or protocol of treatment in detail：

Inclusion criteria

（1）Meets the diagnostic criteria for Acute Coronary Syndrome (ACS). （2）Aged between 18 and 80 years. （3）IL-1β 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：

(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.

Study execute time：

From 2024-09-24

To      2026-09-24

Recruiting time：

From 2025-05-01

To      2026-04-30

Interventions：

66

Group：

Experimental Group

Sample size：

Intervention：

Qi Shen Yi Qi Dropping Pill

Intervention code：

66

Group：

Control Group

Sample size：

Intervention：

Placebo

Intervention code：

Total sample size ： 132

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

China-Japan Friendship Hospital

Level of the institution：

Grade 3A

Outcomes：

Outcome：

Renal function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Monocyte subtypes

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Liver function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Seattle Angina Questionnaire (SAQ)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Inflammatory Hematological Ratio

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Allergy

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Interleukin-1 beta (IL-1β)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

hs-CRP

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The researchers employed a randomized block design (with 4 blocks and 2 groups), generating random sequences in a 1:1 ratio

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Do not share raw data

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The data collection management method is based on Case Report Forms (CRFs) and the Clinical Research Management Platform（Research Manager ResMan)）

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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