Efficacy of Homoeopathic Intervention Belladonna 30 in Preventing Heat related illnesses: A Cluster randomized, Double-Blind, Parallel Arm, Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Incidence of symptoms of heat-elated illnesses (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, parallel arm, placebo-controlled trial to assess the effectiveness of homeopathic medicine Belladonna 30 in preventing heat related illnesses. The population will be enrolled from 15 urban slum clusters of Delhi, where there is a significant chance of getting affected by heat and contracting symptoms of heat related illnesses. Study participants who will fulfilled the inclusion criteria and providing the written consent shall be enrolled in the study and randomized to either group as below:
Group I - H+GM Arm - Homoeopathic intervention Belladonna 30 along with IEC regarding general measures for prevention of heat-related illnesses.
Group II- P+GM Arm - Placebo along with IEC regarding general measures for prevention of heat-related illnesses.
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 illnesses amongst the population of 15 clusters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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 4) Patient with symptoms of acute infectious illnesses at the time of enrolment.
结局指标
主要结局
Incidence of symptoms of heat-elated illnesses (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: 1st Week, 2nd Week, 3rd Week, 4th Week, 5th Week, 6th Week, 7th Week, 8th Week, 9th Week, | 10th Week
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)