CTRI/2025/04/084372尚未招募3 期
Effectiveness of Kushmandak Rasayana in the Management of Moderately Malnourished Children Aged 4-9 Years
Central Council for Research in Ayurvedic Sciences CCRAS4 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2025年4月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 540
- 试验地点
- 4
- 主要终点
- i. Change in weight for age Z score by using WHO child growth standards
研究概览
简要总结
Malnutrition remains a significant issue in India, impacting a substantial proportion of the population, especially children. The study is planned to aassess the effectiveness of Kushmandak Rasayana in weight for age z score of moderately malnourished children aged 4-9 years. It is an open label single arm study. The study is multicentric will be carried out with the coordination of Regional Ayurveda Research Institute, Ahmedabad with four Ayurveda colleges from different states of India. The study will, be sponsored by CCRAS under SMART 2.0 programme.
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
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with weight for age z score between -2 SD and +3SD of the World Health Organization (WHO) weight for age growth standards i.
- •Children of either sex; age group between 4-9 years ii.
- •Children with weight-for-age between -2 SD and -3 SD of the World Health Organization (WHO) weight for age growth standards.
- •Parents or caregivers willing to provide a written informed consent form for the participation of their children.
排除标准
- •Children with Sever Acute Malnutrition ii.
- •Children with known case of Sickle Cell Disease (only SS pattern) iii.
- •Children with diagnosed cases of serious health issues like heart diseases, lung diseases, concurrent hepatic disorder, renal disorder, congenital anomalies, inborn errors of metabolism, malignancy, tuberculosis, HIV etc that might interfere with nutritional recovery iv.
- •Children with acute infections viz- respiratory tract infections, diarrhea, fever etc v.
- •H/o hypersensitivity to the trial drug or any of its ingredients.
- •Patients who have completed participation in any other clinical trial during the past six months.
- •Any other condition which the Investigator thinks may jeopardize the study.
结局指标
主要结局
i. Change in weight for age Z score by using WHO child growth standards
时间窗: Baseline, end of 3rd month, end of 6th month
次要结局
- i. Changes in the score of PedsQL inventory(Baseline, end of 3rd month and end of 6th month)
- ii. Incidence of treatment Emergent Adverse Events(Every Visit)
- iii. Assessment of the tolerability of Kushmandak Ramayana (Assessed through reported withdrawal of participants due to incidence of Treatment emergent adverse events (GIT-related AE specifically) during the study period(every Visit)
- iv. Assessment of treatment adherence through participant self-reported compliance log and used medication containers(30th day visit, 60th Day visit, 90th Day visit, 120th Day and 180th Day visit)
- v. Change in the laboratory parameters from baseline (Complete Blood Count, Liver Function Test, Kidney Function Test)(baseline, and 180th Day)
研究者
Dr Renu Singh
Central Council for Research in Ayurvedic Sciences (CCRAS)
研究点 (4)
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