Skip to content

A Prospective Randomized Double-Blind Placebo-Controlled Clinical Study of Traditional Chinese Medicine Supplementing Qi and Hemostasis Formula on Gastrointestinal Bleeding after Percutaneous Coronary Intervention in acute coronary syndrome

A Prospective Randomized Double-Blind Placebo-Controlled Clinical Study of Traditional Chinese Medicine Supplementing Qi and Hemostasis Formula on Gastrointestinal Bleeding after Percutaneous Coronary Intervention in acute coronary syndrome

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079393
Enrollment
Unknown
Registered
2024-01-02
Start date
2021-12-05
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Gastrointestinal bleeding after PCI in acute coronary syndrome

Interventions

The treatment group:Basic treatment + Chinese medicine Yiqi Zhixue granules
The control group:Basic treatment + Chinese medicine Yiqi Zhixue granule simulator

Sponsors

Wangjing hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria must meet the following conditions: ?18 to 85 years old, male and female; ? It conforms to the diagnostic criteria of acute coronary syndrome of Cardiovascular Society of Chinese Medical Association; ? Patients who have undergone PCI and implanted at least one stent; ? Gastrointestinal bleeding; ? Sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: The exclusion criteria were: ? Gastrointestinal bleeding caused by other reasons: history of gastrointestinal tumor, history of active peptic ulcer or peptic ulcer, bleeding caused by esophageal variceal rupture caused by portal hypertension; ? Warfarin and other drugs affecting platelet aggregation were used in the last two weeks; ? History of anemia, hemoglobin (Hb) was lower than 90g/L before intervention; ? Platelet count is lower than 100×109/L, or blood system diseases, hemorrhagic diseases or bleeding tendency; ? pregnant or lactating women; ? Allergic to drug ingredients or allergic constitution; ? Participated in other clinical researchers within the last 1 month; ? combined with nerve, mental disorders and unable to cooperate or unwilling to cooperate.

Design outcomes

Primary

MeasureTime frame
72-hour rebleeding rate;

Secondary

MeasureTime frame
The bleeding time;7 day rebleeding rate;Amount of blood transfusion during treatment;thrombelastography;TCM syndrome effect score;

Countries

CHINA

Contacts

Public ContactChenhao Zhang

Wangjing hospital, China Academy of Chinese Medical Sciences

2324567223@qq.com+86 136 7139 3316

Outcome results

None listed

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