Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents

Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Bleeding
• Intervention / Treatment: Drug: A Chinese herb formula--Yiwei Jiaohuang Onitment; Drug: Rabeprazole Enteric-Coated Tablets

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jie Zhang; Phone Number: +86 15652385971; Email: zhangjie9496@bucm.edu.cn

Study Locations

• China
  • Beijing, China
    • China-Japan Friendship Hospital
    • Contact: Jie Zhang; Phone Number: +86 15652385971; Email: zhangjie9496@bucm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Drug: A Chinese herb formula--Yiwei Jiaohuang Onitment; Yiwei Jiaohuang Onitment consists of four Chinese herbs: 3g of Duyiwei（Lamiophlomis Herb）, 3g of raw Da Huang(Rhubarb Root and Rhizome (Unprocessed)), 6g of Bai Ji(Bletilla Rhizome) and 10g of Ejiao (donkey-hide gelatin). Prepared as ointment, patients should take one dose daily in the morning on an empty stomach for 2 weeks.; Drug: Rabeprazole Enteric-Coated Tablets; Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks
Active Comparator: Control	Drug: Rabeprazole Enteric-Coated Tablets; Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The rate of negative fecal occult blood test results in the two groups of patients after 2 weeks of intervention.	two weeks of intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Time required for fecal occult blood to turn negative in two groups of patients.	two weeks of intervention
The rate of negative fecal occult blood test results in the two groups of patients after 3 days of intervention.	3 days of intervention
The rate of negative fecal occult blood test results in the two groups of patients after one week of intervention.	one week of intervention
Changes in hemoglobin levels in two groups of patients after 2 weeks of intervention.	two weeks of intervention

Other Outcome Measures

Outcome Measure	Time Frame
Changes in Gut Microbiota Before and After Treatment in Two Groups of Patients	two weeks of intervention

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 10, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Antithrombotic therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 2025-NHLHCRF-PY-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No