KCT0004437已完成未知
Clinical research of comparative effectiveness and safety of JHG002 for chronic temporomandibular joint dysfunction: A multicenter randomized controlled trial)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •(1) Patients with unilateral or bilateral TMJ pain
- •(2) Patients with VAS = 40mm for the area showing TMJ pain (for patients with bilateral pain, the side with worse pain)
- •(3) Patients complaining of persistent of sporadic TMJ pain for at least 3 months
- •(4) Patients diagnosed as myofascial TMD (Axis I: Group 1) based on the RDC/TMD diagnostic criteria [5]
- •(5) Patients aged 19–70 years on the date they sign the consent form
- •(6) Patients who provide consent to participate in the trial and return the informed consent form
排除标准
- •(1) Patients whose current pain episode developed or worsened because of a road traffic accident or traumatic injury
- •(2) Patients diagnosed in Group 2 or 3 of Axis I based on the RDC/TMD diagnostic criteria
- •(3) Patients who have undergone surgery related to the TMJ
- •(4) Patients with other chronic diseases that could interfere with interpretation of the treatment effects or outcomes (e.g., rheumatoid arthritis, neoplastic disease, stroke, or myocardial infarction)
- •(5) Patients currently taking steroids, immunosuppressants, psychiatric drugs, or other drugs that could affect the study results
- •(6) Patients who have received HPP within the last month, or who have taken drugs that could affect pain, such as NSAIDs, within the last week
- •(7) Pregnant or breastfeeding women
- •(8) Patients who have finished participation in another clinical trial within the last month, who participated in another trial within 6 months of selection, or who are planning to participate in another clinical trial during the follow-up period
- •(9) Patients with a history of hypersensitivity after HPP
- •(10) Diabetic patients with uncontrolled blood glucose (fasting blood glucose = 180mg/dl)
- •(11) Patients with aspartate aminotransferase or alanine aminotransferase at least 2 times the normal range at the testing centre
- •(12) Patients with creatinine at least 2 times the normal range at the testing centre
- •(13) Patients suspected to have organic disease
- •(14) Patients with cardiac, hepatic, renal, or other serious complications
- •(15) Patients with psychogenic disease
- •(16) Patients who is taking warfarin
- •(17) Patients with pacemaker
- •(18) Patients who are unable to receive pharmacopuncture due to e.g., inflammation or a wound at the relevant acupoints
- •(19) Patients whose participation in the trial is judged by a researcher to be problematic
研究者
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