Effect of Individualized Homoeopathic Treatment In Influenza Like Illness- A multicentric, Single Blind, Randomized, Placebo Controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 432
- 试验地点
- 9
- 主要终点
- To evaluate effect of Homoeopathic medicines in the treatment of influenza like illness.
研究概览
简要总结
A multicentric randomized, placebo controlled study on effect of individualized homoeopathic treatment on Influenza like illness shall be carried out by Central Council for Research in Homeopathy at its various Institutes/ Units throughout India. Participants shall be selected from both sexes, age ranging between 12-60 years presenting with signs and symptoms of Influenza like illness. Visual analog scale (VAS) ranging from 0-10 shall be used for assessing headache, myalgia, malaise, throat pain, nasal complaints, chill and sweat. Cough shall be measured with scale developed by Hsu et al. The data generated shall be assessed using SPSS statistical package, version 16 and the results shall be disseminated to the medical fraternity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients meet all of the following criteria shall be eligible for study participation: Patients of either sex, age group 12-60 years, presenting to study physician within 36hrs of onset of symptoms.
- •Patients presenting with signs/symptoms of influenza like illnesses: Abrupt onset of fever (≥100.4°F or 38oC body temp.) with at least one respiratory symptom ï›cough, sore throat, or nasal symptom (discharge, obstruction)ï and at least one constitutional symptom (headache, malaise, myalgia, sweats or chills, or fatigue).
排除标准
- •Patients meeting any of the following criteria shall be excluded: •Who have received other medication (anti-viral) within the 36 hours before entry into the study.
- •â€¢Patients who had immunization against influenza or influenza like illnessess for that season.
- •â€¢Inability to comply with the study protocol, including psychiatric diseases.
- •â€¢Immune compromised or with other clinically active illness including cardiac or pulmonary diseases, hemoglobinopathies, renal dysfunction.
- •â€¢Pregnant women.
- •â€¢Lactating mother.
- •â€¢History of drug or alcohol abuse.
结局指标
主要结局
To evaluate effect of Homoeopathic medicines in the treatment of influenza like illness.
时间窗: 2 years
次要结局
- To caopare the complication rate among patients receiving homoeopathic medication as compare to the complication rate in patients receiving placebo.(To compare the efficacy of LM potency vis-a-vis Centesimal potency)