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临床试验/CTRI/2018/03/012613
CTRI/2018/03/012613招募中2/3 期

Effectiveness of individualized homoeopathic medicines vs. Sabadilla in the treatment of upper respiratory tract infections in children: An open-label randomized pragmatic clinical trial

National Institute of Homoeopathy Ministry of AYUSH Govt of India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年3月19日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Wisconsin Upper Respiratory Symptom Survey (WURSS-21); translated Bengali version

研究概览

简要总结

Upper respiratory tract infection include various infections affecting the different parts of upper respiratory tract which mainly includes acute pharyngitis, acute rhinitis, acute sinusitis, acute tonsillitis, and acute otitis media also come under umbrella of URTI. Coldsare responsible for significant morbidity: on average there are 0.4 episodes and 1.2 days for restricted activity per person per year for the common cold. In developing countries, overcrowded dwellings, poor nutrition low birth weight and intense indoor smoke pollution underline the high rates. A recent National Family Health Survey (NFHS-3) data suggests a 5.8% prevalence rate of ARI. Approximately 75% of antibiotics are prescribed for ARI, and many of these prescriptions are unnecessary. This unwarranted use of antibiotics is not only very expensive but has also contributed to rapid increase in antimicrobial resistance to bacteria causing respiratory infections. In few randomized trials, homoeopathy produced significantly different effect beyond placebo. Under such circumstances URTI in pediatric age group become a promising research area in homoeopathy.  In this open, randomized, pragmatic clinical trial at National Institute of Homoeopathy, 100 children suffering from URTI will be randomized to either treatment by empirically selected Sabadilla (verum; n=50) or individualized homoeopathic treatment (control; n=50) to examine whether there are any differences in outcomes between these two groups over 15-17 days of intervention. Translated Bengali version of the WURSS-21 questionnaire, CARIFS-18, and symptom score for RTI will be used as outcome measures. 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
Open Label

入排标准

年龄范围
1.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • Preadolescent children (1-11 years of age)
  • Clinical signs and symptoms of an URTI with a duration of up to 24 hours accompanied with or without fever 37.5áµ’C (axillary body temperature) or higher
  • 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).
  • At least 1 of 5 general symptoms – feeling tired, weakness, body ache, irritable or whiney, or less active.

排除标准

  • Severe or complicated course of URTI.
  • Signs of acute lower respiratory tract disease.
  • Current symptoms mainly induced by other acute ENT diseases.
  • Daily use of antibiotics, steroids and cytotoxic agents.
  • Children on active treatment from any other system of medicine.
  • Children with any uncontrolled systemic disease, infection, and any organ failure.
  • Severe co morbidity including previous malignant disease during the past 5 years prior enrolment.

结局指标

主要结局

Wisconsin Upper Respiratory Symptom Survey (WURSS-21); translated Bengali version

时间窗: Baseline, 4 (±1) days, 8(±1) days, and 15(±2) days after treatment

次要结局

  • Canadian Acute Respiratory Illness and Flu Scale (CARIFS-18); translated Bengali version(Baseline, 4 (±1) days, 8(±1) days, and 15(±2) days after treatment)
  • Symptom Score for RTI (SSRTI); translated Bengali version(Baseline, 4 (±1) days, 8(±1) days, and 15(±2) days after treatment)

研究者

发起方
National Institute of Homoeopathy Ministry of AYUSH Govt of India
申办方类型
Government medical college

研究点 (1)

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