A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving the symptoms of acute viral tonsillitis in children
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Tonsillo-pharyngitis assessment (TPA) score
研究概览
简要总结
Acute viral tonsillitis is one of the commonest types of acute tonsillitis. It commonly affects school-going children of 5 to 15 years of age group and the most commonly produced symptom is sore throat. The aetiology of viral tonsillitis is 70% to 90% of all tonsillitis. Virus causes 70% of sore throats of children in the age groups of 5-16. Although homoeopathic remedies are considered to be useful alternative to conventional therapies, there is paucity of published researches substantiating such claim. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 78 children suffering from acute viral tonsillitis at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Tonsillopharyngitis assessment(TPA) (primary outcome), Days to remission of sore throat, Sore throat pain model (STPM), and Days to complete recovery (secondary outcomes), baseline, every day, up to 7 days, and 10th and 15th days. Group differences will be estimated statistically. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children suffering from acute sore throat of resent onset (≤ 3 days), representing with clinical features of acute vial tonsillitis, scoring ≥ 5 on tonsillopharyngitis assessment (TPA) and viral aetiology confirmed by RTPCR, and bacterial origin will be excluded by bacterial culture.
- •2.Participants of either sex.
- •3.Age between 5 and 15 years.
- •4.Literate patient’s parents; ability to read and write in Bengali and/or English.
- •Illiterate participants will be interviewed by the investigators maintaining adequate privacy to fill up the scale or questionnaires.
- •5.The parents providing written informed consent voluntarily and the children providing with informed assent.
排除标准
- •1.Causes other than viral. 2.Presence of uncontrolled co-morbidities. 3.Self-reported immune-compromised state. 4.Vulnerable population.
- •unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people. 5.Simultaneous participation in any other clinical trials. 6.Exclusion of patient with COVID-19 as detected by the rapid antigen detection test.
结局指标
主要结局
Tonsillo-pharyngitis assessment (TPA) score
时间窗: Baseline, every day, up to 7 days, and 10th and 15th days.
次要结局
- Sore throat pain model (STPM)(Baseline, every day, up to 7 days, and 10th and 15th days.)
- Days to remission of sore throat(Baseline, every day, up to 7 days, and 10th and 15th days.)
- Days to complete recovery(Baseline, every day, up to 7 days, and 10th and 15th days.)