ITMCTR2026001720进行中(未招募)Unknown
Clinical study on Yunnan white ointment in the treatment of fibromyalgia syndrome
China-Japan Friendship Hospital0 个研究点开始时间: 2026年7月13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 120(—)
- 性别
- All
入选标准
- •1: (1) 18 years old and above, regardless of gender;
- •2: (2) When screening, it meets the classification/diagnostic criteria for fibromyalgia syndrome published by the American College of Rheumatology in 2016 (see section 12.1): i. WPI = 7 and Symptom Severity Score (SSS) = 5; Or WPI=4-6 and SSS = 9 Ii. There must be widespread pain, with at least 4 out of 5 areas experiencing pain (excluding the lower jaw, chest, and abdomen) Iii. Diffuse symptoms persist for at least 3 months
- •3: (3) Not receiving non pharmacological or other pharmacological treatment for fibromyalgia, or dissatisfied with current treatment outcomes (VAS = 40mm during screening);
- •4: (4) Voluntarily agree to participate in this study and sign a written informed consent form.
排除标准
- •1: (1) Accompanied by infectious or inflammatory arthritis (such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (i.e., any acute attacks within the past 2 years), or meeting the criteria for other types of systemic autoimmune diseases, with the disease being the primary source of pain;
- •2: (2) Complicated regional pain syndrome, failed back surgery syndrome, persistent or universal pain symptoms related to systemic diseases (such as diabetes peripheral neuropathy, post herpetic neuralgia), untreated hyperparathyroidism, or a history of previous surgery, trauma or other pain sources, which, in the judgment of the investigator, may confuse or interfere with the evaluation of fibromyalgia pain in patients;
- •3: (3) Merge serious systemic diseases, such as severe cardiovascular disease, malignant tumors, or immune suppression status;
- •4: (4) Combining epilepsy or neuropathic pain that requires anticonvulsant treatment;
- •5: (5) Combining a history of severe, controlled, or untreated sleep apnea, or having episodic sleep disorders, cataplexy, periodic limb movement disorders, or other clinically significant sleep disorders that are recorded;
- •6: (6) The planned administration site has active skin diseases, dermatitis, sunburn, unhealed wounds or severe scars;
- •7: (7) Known history of allergies or contact dermatitis to medical adhesives, transdermal patch excipients; Or those who are allergic to experimental drugs or their ingredients (such as Aconitum carmichaelii and Artemisia scoparia);
- •8: (8) Pregnant or lactating women, as well as women of childbearing age who are unable to take effective contraceptive measures evaluated by the researchers during the study period and within 28 days after discontinuing study treatment;
- •9: (9) History of severe mental disorders (such as schizophrenia, bipolar disorder, mental illness), or presence of severe, unstable, or uncontrolled mental conditions (such as borderline personality disorder, severe depressive episodes), or inability to communicate normally, resulting in poor treatment compliance as assessed by the researcher and inability to complete the study according to the research protocol;
- •10: (10) Frequent exposure to overheated environments (such as hot baths, saunas) or strong scrubbing of the planned administration area may affect patch adhesion or drug absorption;
- •11: (11) Due to work, exercise, or lifestyle habits, it is not possible to ensure stable adhesion of the patch to the planned area;
- •12: (12) Currently participating in other clinical trials; Or other investigational drugs or investigational devices cannot be eluted before screening;
- •13: (13) Other situations that the researchers believe are not suitable for participating in this experiment.
研究者
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