ISRCTN11416813已完成未知
Effectiveness of homeopathic treatment (Agraphis nutans 5CH, Thuya occidentalis 5CH, Kalium muriaticum 9CH and Arsenicum iodatum 9CH), as an adjuvant in secretory otitis (SO) in childhood: a randomized parallel double-blind clinical trial
Individual sponsor (Spain)0 个研究点目标入组 220 人开始时间: 2013年2月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 220
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
- 性别
- All
入选标准
- •1. Age: 2 months - 12 years
- •2. Informed consent from parents and / or tutors
- •3. SO diagnosed unilateral or bilateral diagnosed in otolaryngology consultations with pneumatic otoscopy, according to the presence or absence of tympanic mobility. Each ear counted as one unit of primary endpoint.
- •4. Do not be following any regular treatment, specifically especially corticosteroids, antihistamines and mucolytics
排除标准
- •1. Acute Otitis Media or complicated at the time of baseline
- •2. Have not passed the newborn hearing screenig (OAE)
- •3. Concomitant diseases
- •4. Permanent sensorineural hearing loss
- •6. Down Syndrome craneofaciales or other malformations
- •7. Malformations of the outer or middle ear
- •8. Acute Mastoiditis or Cholesteatoma
- •9. Recent vaccination (less than 30 days)
- •10. Cilial motility disorders (Kartagener syndrome)
- •11. Alterations prelingual speech or language
- •12. Obstructive sleep apnea (OSA)
- •13. Adenoidectomy
- •14. Persistence of Tubo-tympanic disease (TTD) or perforated eardrum
- •15. Lactose intolerance or diabetes (incompatible with placebo and homeopathy)
研究者
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