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NCT Number: NCT07339956

Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Rabeprazole Enteric-Coated Tablets

Drug

Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks

Primary outcomes

  1. The rate of negative fecal occult blood test results in the two groups of patients after 2 weeks of intervention.

    Time frame: two weeks of intervention

Secondary outcomes

  1. Time required for fecal occult blood to turn negative in two groups of patients.

    Time frame: two weeks of intervention

  2. The rate of negative fecal occult blood test results in the two groups of patients after 3 days of intervention.

    Time frame: 3 days of intervention

  3. The rate of negative fecal occult blood test results in the two groups of patients after one week of intervention.

    Time frame: one week of intervention

  4. Changes in hemoglobin levels in two groups of patients after 2 weeks of intervention.

    Time frame: two weeks of intervention

Other outcomes

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

    Time frame: two weeks of intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Zhang

CONTACT

[email protected]

+86 15652385971

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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