Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorChina-Japan Friendship Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention

Trial outcomes

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

Sponsors and contacts

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