Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-10

Study Completion Date

2026-08-30

Brief Summary

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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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Detailed Description

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Conditions

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Gastrointestinal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

A Chinese herb formula--Yiwei Jiaohuang Onitment

Intervention Type 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

Intervention Type DRUG

Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks

Control

Group Type ACTIVE_COMPARATOR

Rabeprazole Enteric-Coated Tablets

Intervention Type DRUG

Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks

Interventions

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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.

Intervention Type DRUG

Rabeprazole Enteric-Coated Tablets

Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No