KCT0004028已完成未知
The multi-center clinical trial on the recurrence prevention and safety by injection of Meditoxin® (Botulinum toxin) in chronic sialoadenitis patients
Bundang CHA General Hospital0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
All subjective symptoms decreased significantly until 1 month and then increased. However, at 6 months, all subjective symptoms were determined to be better than before injection. The unstimulated and stimulated salivary flow rate did not show a significant difference over time. No significant difference was noted in parotid gland volume or uptake on salivary SPECT–CT over time.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20?(Year) 至 70?(Year)（—）
- 性别
- All
入选标准
- •The enrolled patient should comply with all of the following criteria.
- •1) Men and women over 20 and under 70
- •2) The patient who have experienced symptoms for more than 6 months
- •3) The patient who repeat 3 or more episodes of sialoadenitis
- •4) The patient who voluntarily decided to participate and signed the consent form before starting this clinical trial
排除标准
- •Patients who fall under any of the following criteria are not allowed to register for this clinical trial.
- •1) Patients who have been confirmed to have a stone or tumor in the salivary gland by CT or MRI
- •2) Patients with salivary glands hypertrophy without pain or pressure sense
- •3) Patients who participated in other clinical trials within last 1 month
- •4) Patients with less than a longer period of five times the half-life of medicines in previous clinical trials
- •5) Patient who have the contraindication of Meditoxin
- •6) In addition to the above, patients who are deemed inappropriate for this trial by investigator
研究者
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