Prevalence of childhood karshya (Grade I and II malnutrition)in Pre-School children across selected villages of Faridabad district and its management with Vidarikandadi Granule: An open lable,Single arm clinical study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Prevalence of Childhood Karshya Grade I & II Malnutrition- The proportion of PreSchool children in the selected villages who meet the diagnostic criteria for Grade I or Grade II malnutrition, based on anthropometric indices such as weight-for-age and BMI-for-age, compared against IAP standards
研究概览
简要总结
The study focuses on the prevalence and management of Childhood Karshya, defined as Grade I and II malnutrition, in pre school children of Faridabad district. The study combines a survey and an interventional trial using Vidarikandadi Granules, an Ayurvedic formulation known for nourishing and strengthening properties. The survey will cover 433 children aged 1 to 5 years through cluster sampling in Anganwadi centres, while the intervention arm will include 50 children diagnosed with Grade I and II malnutrition, given Vidarikandadi Granules for 60 days with follow up of 30 days. Dosage is age adjusted, ranging from 2 g BD at 1 year to 7 g BD at 5 years. Primary objectives are to estimate prevalence rates and evaluate improvements in weight, height, BMI, mid upper arm circumference and skinfold thickness. Secondary objectives include assessing symptoms such as weakness, loss of appetite, fatigue, and developmental lag. The budget sanctioned is Rs 60000, covering drug preparation, packaging, and investigations. Compliance protocols, informed consent, adverse event reporting, and ethics approvals from IRB and IEC are in place. Previous studies cited support Ayurvedic approaches for childhood malnutrition. This study aims to integrate Ayurveda into community based child health strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 5.00 Year(s)(—)
- 性别
- All
入选标准
- •Childrens of age group (1-5 years) of either sex, irrespective of caste, religion and socioeconomic status.
- •Weight of child less than expected as per the age i.e.grade 1 (71-80%) and grade 2 (61- 70%) according to IAP classification of malnutrition.
- •Parents giving consent to participate in the study.
排除标准
- •Patients not willing to participate in the study.
- •Children having celiac disease, malabsorption syndrome, metabolic error, chromosomal disease.
- •Children suffering from any chronic illness, hereditary diseases and malignancies.
- •According to IAP classification more than 80 % (normal) and less than 61 % (nutritional grade III – IV) were excluded.
- •Patient taking antiepileptic drugs or steroids.
- •Children having presence of edema was excluded even if the weight of them is 60-80% (Kwashiorkor patients).
- •Children with neurobehavioral disorders like ADHD, autism etc.
结局指标
主要结局
Prevalence of Childhood Karshya Grade I & II Malnutrition- The proportion of PreSchool children in the selected villages who meet the diagnostic criteria for Grade I or Grade II malnutrition, based on anthropometric indices such as weight-for-age and BMI-for-age, compared against IAP standards
时间窗: 0, 30, 60, 90 day
Improvement in anthropometric parameters weight, height, BMI, MUAC,SFT, after administration of Vidarikandadi Granules over the defined study period in children diagnosed with Childhood Karshya
时间窗: 0, 30, 60, 90 day
次要结局
- Changes in signs and symptoms of Karshya such as Daurbalya weakness, Agnimandya poor digestion, Panduta pallor, and Shrama fatigue, as assessed by subjective parameters before and after treatment(0, 30, 60, 90 day)
研究者
Dr Sushil
All India Institute of ayurveda,sarita vihar,New delhi 110076
