Individualized homoeopathic medicines in chronic tonsillitis of children: Double-blind, randomized, placebo-controlled, pilot trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Questionnaire for evaluation of quality of life in children
研究概览
简要总结
Tonsillitis refers to the inflammation of the pharyngeal tonsils usually extends to the adenoids and the lingual tonsils. Prevalence of tonsilitis cases are maximum in 6-12 yrs age group (61%), followed by 12-18 yrs age group (20%) and in 4-5 yrs children (10%). Conservative treatment includes antibiotics, and surgery, which is usually performed for recurrent or chronic pharyngotonsillitis. Though a number of patients refer homoeopathy for tonsilitis, but rigorous clinical research data is lacking. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 60 children suffering from chronic tonsillitis will be randomized to either individualized homoeopathic medicines (verum; n=30) or identical-looking placebo (control; n=30). We aim to investigate whether there are any differences in outcomes between these two groups over 3 months of intervention. Questionnaire for evaluation of quality of life in children scores, and PedsQL inventory questionnaire version 4.0 scores will be used as the primary and secondary outcome measures rspectively. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Age of 8-18 years and of either sex
- •Presenting with clinical signs and symptoms of chronic tonsillitis – presence of any symptoms: hyperaemia of anterior and posterior palatine arches, enlarged submandibular lymph nodes, halitosis, chronic sore throat, foreign body sensation or a history of expelling foul-tasting and foul-smelling cheesy lumps.
- •Children after the washout period of one week ho underwent treatment with antibiotics.
- •Literate parents/guardian; ability to read English / Bengali.
- •Parents giving writing consent to participate.
排除标准
- •Patient with complication of tonsillitis like peritonsillar abscess and parapharyngeal abscess and infection, cor pulomonale.
- •Patient with uncontrolled systemic diseases or infections.
- •Children presenting with craniofacial abnormalities and neurological disorders.
- •Diagnosed or suspected cases of tonsillar malignancy.
- •Substance abuse and/or dependence
- •Immune compromised states.
结局指标
主要结局
Questionnaire for evaluation of quality of life in children
时间窗: At baseline, and every month up to 3 months
次要结局
- Paediatric quality of life (PedsQLTM) inventory questionnaire version 4.0(At baseline, and every month up to 3 months)
