Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents

NCT07339956 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2025-NHLHCRF-PY-31
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Bleeding

Keywords

Antithrombotic therapy; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Outcomes (1)

• Changes in Gut Microbiota Before and After Treatment in Two Groups of Patients

  two weeks of intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Drug: A Chinese herb formula--Yiwei Jiaohuang Onitment; Drug: Rabeprazole Enteric-Coated Tablets

Control

ACTIVE COMPARATOR

Drug: Rabeprazole Enteric-Coated Tablets

Interventions

A Chinese herb formula--Yiwei Jiaohuang Onitment DRUG

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.

Intervention

Rabeprazole Enteric-Coated Tablets DRUG

Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jie Zhang

CONTACT

+86 15652385971; zhangjie9496@bucm.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)