JPRN-jRCTs031180048已完成4 期
Investigation on efficacy and safety of TJ-50 for the patients with postoperative chronic sinusitis. - TJ-50-E-2017-1
Hatakeyama Hiromitsu0 个研究点目标入组 25 人开始时间: 2018年11月29日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
In this study comparing the efficacy and safety of the conventional treatment group and the TJ-50 group for postoperative chronic sinusitis, there was no significant difference between the two groups in the total change in the total score of Visit 4 from before admission. In addition, no side effects were observed in either group. Although the superiority of the TJ-50 combination group could not be demonstrated in this study, it is considered as a treatment option for postoperative chronic sinusitis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1) The patient is diagnosed with chronic sinusitis 2) The patient is planned treatment by ESS(Endoscopic Sinus Surgery) 3) The patient can be treated with long-term, low-dose macrolide. 4) 20 to 80 years old 5) Both gender6)Written informed consent of this study is obtained from the patient
排除标准
- •1) The patients scheduled to undergo surgical procedures other than ESS as a treatment for chronic sinusitis 2) The patients suspected of typical eosinophilic sinusitis 3) The patients complicated of aspirin asthma 4) The patients complicated with bronchial asthma 5) The patients complicated of NSAIDs allergy 6) Pregnant women, lactating women, and patients who have the possibility or intention of pregnancy 7) The patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study 8) The patients judged unsuitable by researchers
研究者
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