EFFECTIVENESS OF HOMOEOPATHIC TREATMENT IN CASES OF UNDERWEIGHT (IAP GRADE I AND II OF PEM) SCHOOL GOING CHILDREN AGED 6-12 YEARS - A SINGLE-BLIND RANDOMIZED CONTROL STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- 1. To measure changes in the weight-for-age over a 12-month period in underweight (IAP Grade I
研究概览
简要总结
In spite of these ongoing nutrition initiatives, Malnutrition amongst school going children is still evident as seen in various literature reviews as stated above. Indicated Homoeopathic medicine has been helpful in treating cases of malnutrition in underweight children which has been a positive past clinical experience in children below 5 years of age. But a proper Homoeopathic research study project with a rationale and specific study objective is needed to prove the effectiveness of Homoeopathic Treatment in cases of underweight (IAP grade I and II of PEM) school going children.
Thus this Single Blind Randomized Trial aims to evaluate the effectiveness of homeopathic treatment in improving the weight for age in underweight school-going children aged 6-12 years with IAP Grade I and II Protein-Energy Malnutrition (PEM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Underweight (IAP Grade I and II PEM) school-going children.
- •Diagnosed cases of Grade I and II PEM with weight for age calculated according to IAP guidelines.
- •Parental assent obtained for their inclusion in this study.
排除标准
- •Children with only stunting will not be included in this study.
- •Cases of severe concomitant diseases (including severe renal, cardiac, hepatic, and/or immunosuppressive diseases), and cancer.
- •Participation in another clinical study during the 6 months before study enrolment or Previous or current use of homeopathic treatments for undernutrition.
结局指标
主要结局
1. To measure changes in the weight-for-age over a 12-month period in underweight (IAP Grade I
时间窗: Weight for age of all the study subjects will be plotted on the IAP (5-18 years – Boys and Girls) | and WHO (5-19years – Boys and girls) growth charts at the beginning of Intervention in both the | groups and monthly during Follow –up assessment for a period of 12 months
and II PEM) school-going children aged 6-12 years receiving homeopathic treatment and
时间窗: Weight for age of all the study subjects will be plotted on the IAP (5-18 years – Boys and Girls) | and WHO (5-19years – Boys and girls) growth charts at the beginning of Intervention in both the | groups and monthly during Follow –up assessment for a period of 12 months
standard nutritional care (homeopathic treatment group) and those receiving only standard
时间窗: Weight for age of all the study subjects will be plotted on the IAP (5-18 years – Boys and Girls) | and WHO (5-19years – Boys and girls) growth charts at the beginning of Intervention in both the | groups and monthly during Follow –up assessment for a period of 12 months
nutritional care (control group).
时间窗: Weight for age of all the study subjects will be plotted on the IAP (5-18 years – Boys and Girls) | and WHO (5-19years – Boys and girls) growth charts at the beginning of Intervention in both the | groups and monthly during Follow –up assessment for a period of 12 months
2. To compare the weight for age outcomes in underweight (IAP Grade I and II PEM) school-going
时间窗: Weight for age of all the study subjects will be plotted on the IAP (5-18 years – Boys and Girls) | and WHO (5-19years – Boys and girls) growth charts at the beginning of Intervention in both the | groups and monthly during Follow –up assessment for a period of 12 months
children aged 6-12 years in the homeopathic treatment group with the control group after a 12
时间窗: Weight for age of all the study subjects will be plotted on the IAP (5-18 years – Boys and Girls) | and WHO (5-19years – Boys and girls) growth charts at the beginning of Intervention in both the | groups and monthly during Follow –up assessment for a period of 12 months
month period.
时间窗: Weight for age of all the study subjects will be plotted on the IAP (5-18 years – Boys and Girls) | and WHO (5-19years – Boys and girls) growth charts at the beginning of Intervention in both the | groups and monthly during Follow –up assessment for a period of 12 months
次要结局
- 1. To document the specific homeopathic remedies that show significant effectiveness in treatment(of underweight (IAP Grade I and II PEM) school going children aged 6-12 years.)
研究者
Dr Sonali Mandal
Adarsh Shikshan Sansthas Sonajirao Kshirsagar Homoeopathic Medical College