ITMCTR2026001672进行中（未招募）Unknown
A Real-World Clinical Study Evaluating the Efficacy and Safety of Yunnan Baiyao Ointment in the Treatment of Chronic Soft Tissue Injuries
China-Japan Friendship Hospital0 个研究点开始时间: 2026年7月6日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 85（—）
- 性别
- All
入选标准
- •(1) Age 18 years or older; gender is not restricted.
- •(2) The investigator determines that the subject has chronic soft tissue injury requiring treatment. Diagnosis may refer to the criteria in the *Guidelines for Clinical Research on Traditional Chinese Medicine (2002 Edition) – Trial Version*: (1) History of chronic injury and typical age of onset; (2) Pain, swelling, and tenderness at the site of strain; (3) Limited mobility at the joint or adjacent to the joint.
- •(3) Pain score (NRS) =
- •(4) Diagnosed by the investigator as having localized pain lasting more than 3 months, including the face, back, buttocks, neck, abdomen, chest, groin, or extremities.
- •(5) Individuals who voluntarily agree to participate in this study and sign the informed consent form.
排除标准
- •(1) Patients with concomitant fractures or joint dislocations; patients with complete ruptures of soft tissues such as muscles, tendons, or ligaments; patients with concomitant rheumatic diseases, infections, or open wounds.
- •(2) Patients with a history of neurological or psychiatric disorders, such as schizophrenia, depression, epilepsy, or acute epileptic seizures, or those who have been taking psychiatric medications long-term; Those with a known history of alcohol dependence or substance abuse.
- •(3) Patients with concurrent malignant tumors, severe primary cardiovascular disease (cardiovascular disease with significant clinical symptoms and potential for serious complications), severe liver or kidney disease, or severe conditions affecting their survival.
- •(4) Patients with life-threatening soft tissue injuries (e.g., injuries resulting in disability) where the investigator assesses that the efficacy and safety of the study cannot be accurately evaluated.
- •(5) Patients with skin lesions or abnormalities at the application site (e.g., rash, eczema, post-surgical conditions), those with allergic skin conditions; those with a history of allergy to the patch matrix or the investigational drug, or those with a history of multiple allergies (allergic to two or more substances).
- •(6) Individuals with allergies to the study drug or its components (e.g., processed Aconitum carmichaeli, processed Artemisia argyi).
- •(7) Individuals who require frequent exposure to excessively hot environments (e.g., hot baths, saunas) or who perform vigorous scrubbing of the intended application site, which may affect the patch's adhesion or drug absorption.
- •(8) Individuals whose work, exercise, or lifestyle habits make it impossible to ensure stable adhesion of the patch at the intended site.
- •(9) Pregnant or lactating women (as confirmed by the investigator through a medical interview), as well as women of childbearing potential who plan to become pregnant within the next 2 months.
- •(10) Individuals who have participated in other interventional clinical trials within the past 3 months.
- •(11) Individuals with conditions deemed unsuitable for study participation by the investigator, such as physical activity or work conditions that may exacerbate an injury.
研究者
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