A Randomized controlled clinical trial to study the effect of dugdhika churna in the management of karshya in school aged children
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1.Increase in Body Weight
研究概览
简要总结
Study Summary:
Aim: To study the effect of Dugdhika Churna in the management of Karshya (emaciation or underweight) in children aged 6 to 12 years.
Primary Objective: To evaluate the effect of Dugdhika Churna on Karshya in children, focusing on subjective and objective parameters of malnutrition after 2 months of treatment.
Background: Dugdhika Churna is an Ayurvedic herbal formulation traditionally used to manage Karshya, a condition characterized by malnutrition, growth impairment, and weakness, particularly in school-aged children. The formulation is believed to have rejuvenating, digestive, and appetite-enhancing properties, aiding in improved nutritional status and healthy weight gain.
Key Outcomes:
- Increased body weight and improved growth patterns (height, BMI).
- Enhanced appetite and digestion, leading to better nutrient absorption.
- Improvement in biochemical markers like hemoglobin and serum albumin, reflecting better nutritional status.
- Secondary outcomes include improvements in cognitive function, school performance, immune function, and overall quality of life.
Study Design:
- Monitoring at different time points: Every 15 Days to assess the long-term effectiveness of Dugdhika Churna in managing Karshya.
Hypotheses:
- Null Hypothesis: Dugdhika Churna has no effect on Karshya in children after 2 months of treatment.
- Alternate Hypothesis: Dugdhika Churna is effective in treating Karshya in children after 2 months of treatment.
Variables:
- Dependent Variable: Signs and symptoms of malnutrition (e.g., weight, height, BMI, biochemical markers).
- Independent Variable: Drug (Dugdhika Churna), dosage, time, and duration of treatment.
Selection Criteria:
-
Inclusion Criteria:
-
Children aged 6 to 12 years of both genders.
-
Patients selected irrespective of gender, caste, and socio-economic status.
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Exclusion Criteria:
-
Children with severe malnutrition (Grade 3 and Grade 4).
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Children with congenital anomalies.
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Children with physical disabilities.
Malnutrition: Malnutrition refers to inadequate intake, poor absorption, or excessive loss of nutrients, leading to undernutrition. Overnutrition, resulting from overindulgence or excessive intake, is also considered a form of malnutrition. Protein-energy malnutrition is often used interchangeably with undernutrition.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
入选标准
- •1.Patient of both genders between age group of 6 years to 12 years 2.Patient will be selected irrespective of Gender, caste, socio-economic status.
- •3.Patient with poor weight gain ,lean thin body as per IAP ( Grade 1) classification of underweight.
排除标准
- •Patient suffering from severe malnutrition(grade2 grade 3 and grade 4).
- •Patients with congential anomaly.
- •Patients with physical disability.
- •patients suffering from chronic disorder.
- •patients suffering from kwashirkar and marasmus.
结局指标
主要结局
1.Increase in Body Weight
时间窗: 15-20 Days
2.Increase in Body Height
时间窗: 15-20 Days
3.BMI
时间窗: 15-20 Days
次要结局
- 1.Vyayam sauhityam(2.Sauhityam satvam)