Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents

China-Japan Friendship Hospital

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Gastrointestinal Bleeding

Treatments

Drug: Rabeprazole Enteric-Coated Tablets

Drug: A Chinese herb formula--Yiwei Jiaohuang Onitment

Study type

Interventional

Funder types

Other

Identifiers

NCT07339956

2025-NHLHCRF-PY-31

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the clinical efficacy and safety of YiWei Jiaohuang Ointment in treating gastrointestinal bleeding associated with oral antithrombotic therapy. The main question it aims to answer is:

Does Yiwei JiaoHuang Ointment accelerate the conversion to negative results in fecal occult blood tests among patients with gastrointestinal bleeding associated with antithrombotic therapy? Researchers will compare use rabeprazole alone as routine therapy to see if Yiwei JiaoHuang Ointment can accelerate the conversion to negative results in fecal occult blood tests.

Participants will ： Take Yiwei JiaoHuang Ointment every day for 2 weeks. Return to the hospital for a fecal occult blood test after 3 days, 1 week, and 2 weeks of medication.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Oral therapy with at least one antiplatelet or anticoagulant agent, including: aspirin, clopidogrel, ticagrelor, prasugrel, warfarin, rivaroxaban, apixaban, edoxaban, dabigatran, etc.;
BARC stage 1 or 2;
Traditional Chinese Medicine pattern identified as phlegm-heat and blood stasis obstruction syndrome;
Age 18-90 years;
Signed informed consent.

Exclusion criteria

Patients with gastrointestinal bleeding resulting in hemoglobin levels <20 g/L and/or requiring hospitalization;
Gastrointestinal malignancies;
Cases where the source of occult blood cannot be distinguished, such as fresh bleeding from hemorrhoids;
Concurrent use of hemostatic traditional Chinese medicine preparations like Yunnan Baiyao;
Significant liver or kidney dysfunction, with ALT, AST, or serum creatinine exceeding three times the upper limit of normal;
Pregnant women, women planning pregnancy, or lactating women;
Individuals deemed unsuitable for this clinical trial by the investigator.