Efficacy of Homoeopathic Intervention Glonoine 30 in Preventing Heat Related illness: A Cluster-randomized, Double Blind, Parallel Arm, Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25,000
- 试验地点
- 1
- 主要终点
- Incidence of headache, tiredness, extreme fatigue/lethargy, skin rash/ bumps, Painful muscle cramps/ spasm, Nausea, vomiting, loose motion, constipation, stomach cramps, chills, dizziness, fainting, confusion, extreme thirst, heat sensation on head or neck, heavy sweating, muscle weakness induced due to exposure of heatwave
研究概览
简要总结
This is a prospective, randomized, double blind, placebo controlled trial to assess the effectiveness of homoeopathic medicine Glonoine 30 for prevention of Heat related illness. The study is a field study wherein apparently healthy participants will be enrolled from the population residing in 05 urban slums of Delhi, where there is significant chance of getting affected by heat related illness. Study participants who fulfil the inclusion criteria and willing to provide informed written consent shall be enrolled in the study and randomized to either group as below:
Group I - H+GM’ Arm - Homoeopathic intervention Glonoine 30 along with IEC regarding general measures for prevention of heat related illnesses will be provided to 03 clusters.
Group II - ‘P+GM’ Arm - Placebo along with IEC regarding general measures for prevention of heat related illnesses will be provided to 02 clusters.
The study will be carried out till the termination of heat wave as per Indian Meteorological Department. The primary outcome shall be incidence of heat related illness amongst population of 05 slums.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntary written Informed consent by the family head.
排除标准
- •Pregnant or lactating females.
- •Child below age of 1 year.
- •Patients with malignancy, immune-compromised state, life threatening diseases, end stage diseases Patient with symptoms of acute infectious illnesses at the time of enrolment.
结局指标
主要结局
Incidence of headache, tiredness, extreme fatigue/lethargy, skin rash/ bumps, Painful muscle cramps/ spasm, Nausea, vomiting, loose motion, constipation, stomach cramps, chills, dizziness, fainting, confusion, extreme thirst, heat sensation on head or neck, heavy sweating, muscle weakness induced due to exposure of heatwave
时间窗: Daily
次要结局
- Intensity of symptoms (headache, tiredness, extreme fatigue/lethargy, skin rash/ bumps, Painful muscle cramps/ spasm, Nausea, vomiting, loose motion, constipation, stomach cramps, chills, dizziness, fainting, confusion, extreme thirst, heat sensation on head or neck, heavy sweating, muscle weakness) induced due to exposure of heatwave(Daily)
- Mean duration of symptoms (headache, tiredness, extreme fatigue/lethargy, skin rash/ bumps, Painful muscle cramps/ spasm, Nausea, vomiting, loose motion, constipation, stomach cramps, chills, dizziness, fainting, confusion, extreme thirst, heat sensation on head or neck, heavy sweating, muscle weakness) induced due to exposure of heatwave(Daily)
- Proportion of cases of heat related illnesses requiring hospitalization(At the time of analysis)
研究者
Dr Debadatta Nayak
Central Council for Research in Homoeopathy