Randomized controlled clinical study to evaluate the efficacy of vidangadi lauha in rasa pradoshaja pandu in children W.S.R to iron deficiency anaemia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- assessment will be done as per the classical lakshanas of rasa pradoshaja pandu and grades will be given as per the WHO scoring methodology in ayurveda and lab investigations.
研究概览
简要总结
Adolescence is a phase of transition from childhood to adulthood where there is a strong need of physical and mental support. Since there is a marked growth spurt at this phase, Nutritive substances such as Iron, Proteins and Vitamins like Vit. C, Vit. B12 and Folic acid are necessary for erythropoiesis. The deficiency of these substances leads to Nutritional deficiency anaemia. According to National Family Health Survey-4 anaemia in children can result in impaired cognitive performance, motor development, and scholastic achievement. Iron deficiency anaemia is the most common prevalent nutritional deficiency anaemia affecting children & adolescents worldwide. The epidemiological data shows an increased incidences of iron deficiency at 3 stages: Neonatal, in pre-school, and in adolescents. According to National Health Mission 2019-2020 index, Bengaluru holds 17th rank in the Anaemia Mukt Bharat, Karnataka has been asked to reduce the incidence of anaemia by 3% every year to achieve the goal by 2022. As per the study held at Rajarajeswari Medical College & Hospital Kambipura, Bengaluru, the prevalence of iron deficiency anaemia from the age of 10 years to 19 years was 47.7%. Adolescent group are highly prone to develop iron deficiency anaemia due to rapid pubertal growth. Hence, there is a strong need to approach this adolescent population through school visits, nutrition education and oral supplements. Iron deficiency anaemia can be correlated with RasaPradoshaja Pandu as per Ayurvedic classics. Mere iron supplementation may not be sufficient in this condition, but requires correction of Rasagni to improve iron absorption. Also iron supplements cause side-effects like epigastric irritation, constipation, nausea etc. Thus a novel combination of the drugs which can do Rasagni Deepanaand supplement iron along with prevention of side-effects is the need of the hour. A safe and effective formulation which is also palatable is necessary in children with Iron Deficiency Anaemia,Vidangadi Lauha is one such preparation mentioned for the treatment of Anaemia by Chakradatta which needs to be evaluated for its efficacy in children.
Hence the present study is an effort to evaluate the efficacy of “Vidangadi Lauha†in Rasa Pradoshaja Pandu in children W.S.R. to Iron Deficiency Anaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 10.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of age group between 10-16 years irrespective of religion, gender, and socio-economic status will be included.
- •Children with cardinal signs of iron deficiency anemia will be included.
- •Children with haemoglobin 8g/dl to12g/dl (mild to moderate anemia) and hematocrit less than 36% will be included.
- •Children with clinical features of Rasa Pradoshaja Pandu will be included.
排除标准
- •Children less than 10 years and more than 16 years of age will be excluded.
- •Children with severe anemia less than 8g/dl will be excluded.
- •Children with congenital anomalies will be excluded.
- •Children with inborn errors of metabolism will be excluded.
- •Other hemoglobinopathies like Thalessemia, Sickle cell anaemia etc.
- •will be excluded.
- •Children with other systemic illnesses will be excluded.
- •Children with Mritbhakshana Janya Pandu will be excluded.
结局指标
主要结局
assessment will be done as per the classical lakshanas of rasa pradoshaja pandu and grades will be given as per the WHO scoring methodology in ayurveda and lab investigations.
时间窗: assessment will be done on | 0th day (before starting medication) | 60th day (followup)
次要结局
- investigations (haemoglobin percentage and complete blood count) will be done to assess iron deficiency anaemia.(before intervention- 0th day)