A Community Based Study to Evaluate the Efficacy of PriyalaadiModaka in the Management of Karshya with special reference toMalnutrition in Children
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. Change in Weight.
研究概览
简要总结
PURPOSE :
-
To mitigate and treat malnutrition in children.
-
To evaluate the effect of Priyaladi Modaka in the management
of Karshya with special reference to malnutrition in children.
-
To assess the prevalence of malnutrition in the study area.
-
To identify the correlations of malnutrition in the study
population.
NEED OD STUDY: Despite the status, 14 per cent of India’s
population is undernourished. A recent report reveals that in
Rajasthan 36.7% of children under the age of five are underweight, 39.1% are stunted and 23.0% are wasted. But, still
there is no satisfactory solution and management for malnutrition
and it is the need of the time to look into the alternative systems
for the management.
NULL HYPOTHESIS (H 0 ) :
There is no difference in effect of dietary guideline alone and
with Priyalaadi Modaka in the management of Karshya with
special reference to malnutrition in children.
ALTERNATE HYPOTHESIS (H 1 ):
If the null hypothesis is rejected alternative hypothesis will be
accepted i.e. Dietary guideline along with Priyalaadi Modaka
has significant role in the management of Karshya with special
reference to malnutrition in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 13.00 Month(s) 至 60.00 Month(s)（—）
- 性别
- All
入选标准
- •Children aged 13-60 months of either sex with no major medical complication.
- •Mother and care taker trainable to provide home based diet.Â
- •Parents or caretaker willing to participate in the clinical trial. 4.
排除标准
- •Children suffering from severe malnutrition, who need hospitalization.
- •Tuberculosis, Cerebral palsy, Congenital heart diseases, Known metabolic disorders, Known mal-absorption syndromes, Chromosomal malformations, Renal or hepatic disorders.
- •Caretakers not willing to participate in the study.
结局指标
主要结局
1. Change in Weight.
时间窗: Baseline, 14thday, 28th day, 42th day and 56th day.
次要结局
- Change in MUAC, Skinfold thickness and BMI.(Baseline, 14thday, 28th day, 42th day and 56th day.)