Clinical Evaluation of Navayasa Lauha in the Management of Iron Deficiency Anaemia in School Going Children – A Single Arm Interventional Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in Haemoglobin, RBC Count, PCV, MCV, MCH, MCHC, PBS, Serum Iron, Serum Ferritin and TIBC
研究概览
简要总结
Infants, preschool children, and adolescents are at greatest risk of developing iron deficiency and its resultant anaemia, which later affects their physical as well as mental development. The effect of anaemia on child development are serious: poor cognitive development, decreased future learning, and school achievement, decreased resistance to illness and disease and eventually reduced wages and quality of life. Numerous studies have shown that moderate anaemia with haemoglobin less than 10g/dl is associated with depressed mental, social, cognitive and motor development in children which may not be reversible.
Nutritional deficiency is considered to be the main culprit in Iron Deficiency Anaemia. The management programmes are exclusively aimed on providing iron and other nutrients. On the other hand, various factors that hamper the digestion and metabolism are postulated as the key etiological factors for Pandu.
Hence there is always a search for better remedies which will not cause adverse effects like gastrointestinal disturbances, metallic taste and can be well accepted by children. There are many formulations listed in different Ayurveda texts for the management of Pandu. Among them Navayas Lauha which is explained by Acharya Charaka in Panduroga Chikitsa is the one which contains iron and other components which can correct the metabolism by which absorption and bioavailability of iron as well as other nutrients can be enhanced. Studies conducted earlier have shown that correction of metabolism is an essential part in the management of nutritional deficiency conditions.
Thus, this study is planned to clinical evaluation of Navayasa Lauha in the management of Iron Deficiency Anaemia in school going children-single arm prospective interventional trial*.*
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
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 06 to 12 years of either sex.
- •Children with Iron deficiency anaemia.
- •Children with Haemoglobin% less than 11.9 gm/dl and more than 7.0 gm/dl.
- •(Mild and moderate anaemia).
排除标准
- •Children with severe anaemia (Hb more than 7.0 gm/dl)
- •Children with major systemic illness requiring hospitalization.
- •Children with co morbidities like TB, UTI, and Bleeding disorders.
- •Children with any congenital anomalies or birth defects or genetic disorder.
- •Children with evidence of malignancy.
- •Children with concurrent serious hepatic dysfunction (defined as AST and or ALT more than 3time of the upper normal limit) or renal dysfunction (define as S.
- •Creatinine more than 1.2mg/dl).
结局指标
主要结局
Changes in Haemoglobin, RBC Count, PCV, MCV, MCH, MCHC, PBS, Serum Iron, Serum Ferritin and TIBC
时间窗: 2 months
次要结局
- Change in quality of life in children with Iron deficiency anaemia (Pandu)(2 months)
研究者
Dr.SURENDRA SINGH GURJAR
National Institute of Ayurveda