Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат Rabeprazole Enteric-Coated Tablets
  Rabeprazole Enteric-Coated Tablets10mg once a day for 2 weeks

Первичные конечные точки

• The rate of negative fecal occult blood test results in the two groups of patients after 2 weeks of intervention. [Срок оценки: two weeks of intervention]

Вторичные конечные точки (4)

• Time required for fecal occult blood to turn negative in two groups of patients. [Срок оценки: two weeks of intervention]
• The rate of negative fecal occult blood test results in the two groups of patients after 3 days of intervention. [Срок оценки: 3 days of intervention]
• The rate of negative fecal occult blood test results in the two groups of patients after one week of intervention. [Срок оценки: one week of intervention]
• Changes in hemoglobin levels in two groups of patients after 2 weeks of intervention. [Срок оценки: two weeks of intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT07339956 · 2025-NHLHCRF-PY-31

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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