A randomized controlled clinical study to evaluate add on effect of Baladi Granules in the management of karshya vyadhi (mild to moderate undernutrition) in children .
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- To assess the add on effect of Baladi granules on weight gain in the management
研究概览
简要总结
Title: A Randomized Controlled Clinical Study to Evaluate Add-on Effect of BaladiGranules in the Management of Karshya Vyadhi (Mild to Moderate Undernutrition) in Children .
Background: Undernutrition (Karshya Vyadhi) remains a significant public health concern in India, particularly among children under five. Conventional approaches have limitations, especially in younger age groups. Baladi Granules, a proprietary Ayurvedic formulation, are designed to nourish the body tissues (Saptadhatus) and address Vata dosha imbalances associated with undernutrition.
Objectives:
Primary Objective: To assess the add-on effect of Baladi Granules on weight gain in children with mild to moderate undernutrition.
Secondary Objectives: To evaluate the impact of Baladi Granules on other nutritional parameters such as MUAC and height-for-age.
Materials and Methods:
This 30-day, open-label, randomized controlled trial included 116 children aged 1–12 yearswith mild to moderate undernutrition. Participants were randomly allocated into two groups:
Group A: Received Baladi Granules (1 gm/year/day) with milk + standard undernutrition diet (IAP guidelines)
Group B: Received only the standard undernutrition diet Anthropometric and clinical assessments were carried out at baseline, 15 days, and 30 days.
Results: Group A showed statistically significant improvement in weight gain compared to Group B, fulfilling the primary objective. Secondary parameters including MUAC and height-for-age also improved significantly in Group A.
Statistical analysis using Wilcoxon Signed Rank Test**, Paired t-Test, Mann-Whitney U Test**, and Unpaired t-Test confirmed the efficacy of the intervention. A greater proportion of children in Group A experienced **marked improvement (>75%)**in overall health compared to Group B.
Conclusion: Baladi Granules, as an adjunct to a standard diet, demonstrated significant benefits in improving weight, MUAC, and height-for-age in undernourished children. The formulation is a safe, effective, and affordable Ayurvedic intervention for the management of Karshya Vyadhi.
Limitations and Future Scope:
Short study duration and limited sample size. Future long-term, multi-center studies with biochemical parameters are recommended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children age between 1 to 12 years.
- •2.Children whose weight for age is above 60 percent & below 80 percent of expected weight (mild to moderate – grade 1 and grade 2) according to IAP classification.
排除标准
- •1.Children with severe symptomatic under nourishment.
- •Children with chronic/infective illnesses e.g.TB, immune compromised disease etc.
- •3.Children with inborn errors of metabolism, malignancies and genetic disorders.
- •Children whose weight for age is below 60% (severe-grade 3)& above 80% of expected weight according to IAP classification.
结局指标
主要结局
To assess the add on effect of Baladi granules on weight gain in the management
时间窗: 30 days
of karshya vyadhi (mild to moderate undernutrition) in children
时间窗: 30 days
次要结局
- To assess the add on effect of Baladi granules on other parameters like(MUAC,height for age etc. in the management of karshya vyadhi (mild to moderate)
研究者
Dr Mosim Momin
Dr D Y Patil College of Ayurveda and Research centre