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Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started2026-01-10
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 26, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-01-23
Study Identification, Study Status, Outcome Measures, Eligibility v1
Eligibility criteria-48 characters
Inclusion Criteria: (1) Oral therapy with at least one antiplatelet or anticoagulant [...] warfarin, rivaroxaban, apixaban, edoxaban, dabigatran, etc.; (2) BARC stage 1 or 2; (3) Traditional Chinese Medicine pattern identified as phlegm-heat and blood stasis obstruction syndrome; (4) Age 18-90 years; (5) Signed informed consent. Exclusion Criteria: (1) Patients with gastrointestinal bleeding resulting in hemoglobin levels <20 g/L and/or requiring hospitalization; (2) Gastrointestinal malignancies; (3) Cases where the source of occult blood cannot be distinguished, such as fresh bleeding from he [...] [...]
Secondary endpointsdetails revised at 4 of 4 entries
Study title-31 characters
Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents: A Randomized Controlled Trial
2026-01-06
Original filing
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.
Trial Details
NCT Number NCT07339956
Lead Sponsor China-Japan Friendship Hospital
Conditions Gastrointestinal Bleeding
Enrollment 60 participants
Start Date 2026-01-10
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-26