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Not yet recruiting NCT07339956

Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents

Early Phase I Interventional Gastrointestinal Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A Chinese herb formula--Yiwei Jiaohuang Onitment, Rabeprazole Enteric-Coated Tablets.
Who it may be relevant to
Registry conditions: Gastrointestinal Bleeding. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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 outcome measures (4)
  • Time required for fecal occult blood to turn negative in two groups of patients. [Time frame: two weeks of intervention]
  • 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]
  • 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]
  • Changes in hemoglobin levels in two groups of patients after 2 weeks of intervention. [Time frame: two weeks of intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT07339956 · 2025-NHLHCRF-PY-31

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗