ITMCTR2026001692招募中Unknown
A Clinical Study on the Efficacy and Safety of Sanhuang Xiaozhen Decoction in the Treatment of Chronic Spontaneous Urticaria (Wind-Heat Syndrome)
Changzhou Hospital of Traditional Chinese Medicine0 个研究点开始时间: 2026年3月25日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 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 70（—）
- 性别
- All
入选标准
- •(1) Meets the Western medicine diagnostic criteria for chronic spontaneous urticaria;
- •(2) Identified as Wind-Heat Syndrome in traditional Chinese medicine;
- •(3) Age between 18 and 70 years old (inclusive), with no gender restrictions;
- •(4) Retrospective evaluation within 7 days prior to enrollment, with UAS7 score (range 0-42) satisfying 7 = UAS7 score < 28;
- •(5) Voluntarily participates in this clinical trial and signs the informed consent form.
排除标准
- •(1) Clearly defined underlying causes of chronic urticaria other than CSU, including acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticaria;
- •(2) Any of the following diseases that may present with urticaria and/or angioedema symptoms: urticarial vasculitis, Schnitzler syndrome, and other autoinflammatory syndromes; adult Still's disease, and other autoimmune diseases; neutrophilic urticarial dermatoses; subacute cutaneous lupus erythematosus; acute febrile neutrophilic dermatosis; pigmentary urticaria; erythema multiforme; mastocytosis; hereditary or acquired angioedema; lymphoma; leukemia; or generalized cancer;
- •(3) Any chronic pruritic dermatosis other than CSU that may affect the evaluation of efficacy (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, and senile pruritus);
- •(4) Concomitant severe cardiovascular, digestive, endocrine, nervous system diseases, or other conditions that, in the investigator's judgment, may affect the evaluation of efficacy and safety or compliance after enrollment;
- •(5) Liver function tests (ALT, AST) with any value exceeding 1.5 times the upper limit of normal reference values, or serum creatinine (Scr) exceeding the upper limit of normal reference values;
- •(6) Use of oral, intravenous, or other forms of glucocorticoids and immunosuppressive drugs within 1 month prior to enrollment;
- •(7) Use of drugs for urticaria, other than emergency medications (loratadine), within 1 week prior to enrollment, or use of loratadine for more than 3 days, or use of preparations (decoctions, granules, traditional Chinese medicine formulations, etc.) prohibited during the study period;
- •(8) Pregnant or breastfeeding women, women planning pregnancy, or those unable to adopt effective contraceptive measures;
- •(9) Concomitant severe intellectual or mental disorders;
- •(10) History of alcohol or substance abuse within 1 year prior to the trial;
- •(11) History of allergy to the components or excipients of the investigational drug or emergency medications;
- •(12) Participation in any interventional clinical trial within 30 days prior to screening.
研究者
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