Individualized Homoeopathic Medicines in the Treatment of Upper Respiratory Tract Infections in Children Using Kent’s Repertory: A Double-blind, Randomized, Placebo controlledClinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Canadian Acute Respiratory Illness and Flu Scale (CARIFS-18)
研究概览
简要总结
Upper respiratory tract infection includes any infection above the vocal cord. Infections affecting the different parts of the upper respiratory tract which mainly includes acute pharyngitis, acute rhinitis, acute sinusitis, acute tonsillitis, and acute otitis media. Children are more prone to suffer from this problem. Homoeopathic physicians treat thousands of patients belongs to such age group. Few clinical trials were conducted and showed some positive results. However, trials with individualised homoeopathy are scarce. We aim to evaluate the effect of Individualised Homoeopathic treatment in pediatric URTI and also looking at the feasibility of further similar trials. The result of the study expected to help us deciding many facets of the Individualised homoeopathic treatment in such cases and designing future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
入选标准
- •Willingness and consent of the parents or immediate caregivers for inclusion in this study 2.Clinical signs and symptoms of a URTI with a duration of up to 24hours accompanied with or without fever ≥37.5áµ’C (axillary body temperature) 3.At least 1 of 3 types of URTI symptoms – Nasal (plugged nose, runny nose, sneezing), Pharyngeal (scratchy throat, sore throat, pharyngeal hyperaemia), Cough (ordinary cough without suspicion of acute lower respiratory tract disease).
- •4.At least 1 of 5 general symptoms – feeling tired, weakness, body ache, irritable or whiney, or less active.
排除标准
- •1.Severe or complicated course of URTI.
- •2.Persistent fever more than 1020F 3.Signs of acute lower respiratory tract disease.
- •4.Current symptoms mainly induced by other acute ENT diseases.
- •5.Daily use of antibiotics, steroids and cytotoxic agents.
- •6.Children on active treatment from any other system of medicine.
- •7.Children with any uncontrolled systemic disease, infection, and any organ failure.
- •8.Severe co morbidity including previous malignant disease during the past 5year prior enrolment.
结局指标
主要结局
Canadian Acute Respiratory Illness and Flu Scale (CARIFS-18)
时间窗: Baseline, 3 days, 7 days, 14 days
次要结局
- Symptom Score for RTI(Baseline, 3 days, 7 days, 14 days)
- Time taken for complete resolution of symptoms(Counted in days)
- Adverse events (persistent fever, additional medication, spread of infections etc.)(Event record)