Evaluation of Efficacy of Charakokta Ksharagad by Open Labelled Randomized Controlled Clinical Trial in the Management of Pandu (Iron Deficiency Anemia) in Municipality School Going Adolescents in Amravati City.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Increase in Hemoglobin %
研究概览
简要总结
Current study is open labeled, two arms, Randomized Controlled Clinical Trial. Purpose of the Study: Nutritional anemia is a major public health problem in India and is primarily due to iron deficiency. Anemia especially affects women of reproductive age and young children. Adolescents (age 10–19 years) are at high risk of iron deficiency and anemia. Especially girls, particularly those between the age of 12–15 years, are more vulnerable to iron deficiency mainly because requirements are at a peak. As Iron deficiency anemia is a very common prevalent disease in the society and the side effects of oral allopathic iron preparations are very common, therefore to get a better alternative, it is a need of hour to gather a clinical data regarding the efficacy of an ayurvedic herbo-mineral medicine ‘ksharagad’ vati in Pandu(iron deficiency anemia). With the aim that herbo-mineral medicine Ksharagad vati may be effective to manage iron deficiency anemia in adolescents without any side effects. As the previous researcher establishes that some of the content of ksharagad isolately shows hematinic actions, therefore we have decided to study the properties of herbo-mineral compound ‘Ksharagad’ as a whole by using both Ayurvedic parameters and principles as well as Modern parameters (laboratory analysis) to evaluate its efficacy in other disorders like anemia and effective, strong and potent drug to be used by physician in future in the specialty other than its ancient use in toxicology on the basis of its newly defined properties. Hence it is decided to evaluate the effect of Ksharagad vati in the management of iron deficiency anemia in adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •subjects having classical symptoms of pandu that is iron deficiency anemia and hemoglobin level ranging from 8 to 11.9 g/dl at the time of screening After obtaining written informed consent from the parents/guardian subjects will be included in the study.
排除标准
- •Subject Age less than 12 yrs and greater than 14 yrs.
- •2.Hemoglobin less than 8g/dl that is of severe anemia.
- •3.known cases of Anemia due to excessive blood destruction e.g. Thalassaemia, Sickle cell anemia and haemolytic anemia.
- •4.known case of Megaloblastic anemia.
- •5.known cases of Anemia due to blood loss such as menorrhagia, GI loss etc.
- •6.known cases of Anemia secondary to chronic systemic disorders e.g. due to infection, rheumatoid arthritis, chronic renal & liver disease and widespread malignant disease.
- •7.Any critical illness.
- •8.Subjects and their parents not willing to participate in the study.
结局指标
主要结局
Increase in Hemoglobin %
时间窗: at the end of 45 days
次要结局
- Improvement in signs and symptoms of the disease described in ayurvedic classics & modern literature.(after every 15 days)
