跳至主要内容
临床试验/CTRI/2021/12/038881
CTRI/2021/12/038881招募中2 期

Individualized homeopathic medicines in upper respiratory tract infections in children: Double-blind, randomized, placebo-controlled pilot trial

D N De Homoeopathic Medical College Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月29日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Number of patients in each group showing complete disappearance of the symptoms of upper respiratory tract infection.

研究概览

简要总结

Upper respiratory tract infections (URTI) include various infections affecting the different parts of upper respiratory tract (URT) extending from nose to vocal cords and mainly include acute pharyngitis, acute rhinitis, acute sinusitis, acute tonsillitis, and acute otitis media. In developing countries, on an average, every child has 6.8 to 8.8 episodes of acute respiratory tract infections (ARTI) per year. In India, the number is 0.37 episodes per child-year. Morbidity accounts for  60-80% of time lost from school by children. Apart from impairing the quality of life, economic burden by the cost of treatment and the number of absentees from work by parents for their children is a major problem. Homeopathic treatment is regarded as a possible option for URTI. However, the research evidence remains compromised.  In this double-blind, randomized, placebo-controlled pilot trial of individualized homeopathic medicines in treatment of URTI at D. N. De Homoeopathic Medical College and Hospital, 60 children suffering from ARTI will be randomized to receive either individualized homeopathic medicines or identical-looking placebo for a period of 15 days. The number of children showing complete disappearance of ARTI symptoms, Wisconsin Upper Respiratory Symptom Survey (WURSS-21) and Upper Respiratory Tract Infection symptom severity scale (URI-SSS) will be assessed at baseline and after 4, 8 and 15 days of intervention. Adequate fluid and fruit intake will be advised to all the enrolled children. Comparative analysis will be carried out to detect group differences. 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
1.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • Clinical signs and symptoms of an upper respiratory tract infections with a duration of greater than or equal to 24 hours with or without fever greater than or equal to 37.5 degree Celsius.
  • At least 1 of 3 types of upper respiratory tract infections symptoms – nasal (plugged nose, runny nose, sneezing), pharyngeal (scratchy throat, sore throat, pharyngeal hyperemia), and 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.
  • Literate guardians or attendants capable of understanding and filling the questionnaire and providing written informed consent.

排除标准

  • Severe or complicated course of upper respiratory tract infections.
  • Signs of acute lower respiratory tract infections.
  • COVID-19 positive cases.
  • Current symptoms mainly induced by other acute ear, nose, throat diseases.
  • Daily use of antibiotics, steroids and cytotoxic agents.
  • Immune-compromised state.
  • Already undergoing homeopathic or other modes of treatment for upper respiratory tract infections.

结局指标

主要结局

Number of patients in each group showing complete disappearance of the symptoms of upper respiratory tract infection.

时间窗: Baseline and after 4, 8 and 15 days

次要结局

  • Wisconsin Upper Respiratory Symptom Survey (WURSS-21)(Baseline and after 4, 8 and 15 days)
  • Upper respiratory tract infection symptom severity scale (URI-SSS)(Baseline and after 4, 8 and 15 days)

研究者

申办方类型
Government medical college

研究点 (1)

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