KCT0008802招募中Unknown
Prospective, Confirmatory Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Biodegradable Microneedle Acupuncture: A Randomized, Sterile Acupuncture Controlled, Parallel, Single blinded
aju Dongshin University Korean Medicine Hospital0 个研究点目标入组 224 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 224
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
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. Men or women aged between 19 and 70 at the screening visit.
- •2. Patients requiring acupuncture treatment on eight periocular acupoints (bilateral GB14, TE23, ST1, EX-HN5).
- •3. Patients requiring a total of 12 treatments for 4 weeks (3 times/week).
- •4. Patients who voluntarily submitted written consent.
排除标准
- •1. Patients with a fear of acupuncture or a past history of needle hypersensitivity.
- •2. Patients with valvular heart disease, pacemakers, or implantable defibrillators.
- •3. Patients taking medications that may cause hemostatic disorders, including anticoagulants, antiplatelet agents, and aspirin, or who have thrombocytopenia.
- •4. Patients with skin diseases that may interfere with adverse events monitoring of BMA and sterile acupuncture (mainly face, but not limited to). Examples of skin diseases includes rosacea, atopic dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform rash induced by drugs or cosmetics, bacterial folliculitis, autoimmune diseases, periocular dermatitis, carcinoid syndrome, facial psoriasis, and facial eczema.
- •5. Patients with adhesive allergy.
- •6. Patients with dermatologic lesions at the treated acupoints, which may have the risk of acupuncture-related infections.
- •7. Patients who took medications such as antibiotics, oral corticosteroids, and immunosuppressants within 4 weeks prior to the screening visit.
- •8. Patients with liver disease, including cirrhosis and liver cancer.
- •9. Patients with kidney disease, including acute/chronic renal failure and nephrotic syndrome.
- •10. Patients with acute severe heart disease, including heart failure, myocardial infarction, and stroke.
- •11. Patients who took antipsychotic medications within 3 months prior to the screening visit.
- •12. Women who are pregnant, lactating, or planning to become pregnant during the study period.
- •13. Others deemed inappropriate for participation in this study by the principal investigator.
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