Randomized Controlled Clinical Trial of Vidangadya louha Vati on Alparaktata of Panduroga (Iron Deficiency Anemia) in School Going Children
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Increase in Hemoglobin (%) after 60 days of oral administration of Vidangadya louha Vati on Alparaktata of Panduroga (Iron Deficiency Anemia) in School Going Children
研究概览
简要总结
The present study is a Randomized Controlled Clinical Trial designed to evaluate the efficacy and safety of Vidangadya Louha Vati in the management of Alparaktata of Panduroga (Iron Deficiency Anemia) in school-going children. Iron deficiency anemia is one of the most common nutritional disorders seen in the paediatric age group, and it is associated with impaired performance in mental and physical functions, including physical coordination and capacity, cognitive abilities, and social and emotional development in children.
In this study, eligible children diagnosed with Alparaktata will be randomly allocated into two groups. The trial group will receive Vidangadya Louha Vati in an age-appropriate dose for 60 days, while the control group will receive Dhatravleha in age appropriate dose. Assessments will be made on both subjective parameters (clinical signs and symptoms of Panduroga such as panduta, Akshikuta Shotha, Aarohannayas, Shrama) and objective hematological parameters (Hemoglobin %, RBC count, RDW, MCV, MCH, MCHC, Sr. Iron, etc.).
The primary outcome will be the improvement in Hemoglobin percentage and clinical symptoms after 60 days of treatment, comparing pre- and post-treatment values.
The study aims to scientifically validate the classical Ayurvedic formulation Vidangadya Louha Vati as an effective and safe remedy for Iron Deficiency Anemia in school-going children, thereby contributing to evidence-based Ayurvedic pediatric practice (Kaumarbhritya).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients showing cardinal signs of Pandu.
- •Children in between the age group of 6 years to 12 years .
- •Hemoglobin Percentage between
- •10 gm/dl.
- •Patients diagnosed as iron deficiency anemia by performing CBC.
- •Patients will be included irrespective of sex, religion, caste, socio- economic status and food habits, etc.
排除标准
- •Mridbhakshanjanya pandu .
- •Hb percentage below 6 gm/dl and above 11 gm/dl.
- •Patients suffering from major systemic disorders like severe jaundice, congenital heart disease, bleeding disorders & all seropositive patients.
- •Diagnosed cases of Hemolytic disorders.
- •Acute bleeding due to recent trauma will be excluded.
- •Other types of Anemia like Sickle cell, Thalassemia, Megaloblastic, Aplastic Anemia etc.
- •Any patient requiring Hospitalization.
结局指标
主要结局
Increase in Hemoglobin (%) after 60 days of oral administration of Vidangadya louha Vati on Alparaktata of Panduroga (Iron Deficiency Anemia) in School Going Children
时间窗: after 60 days
次要结局
- 1. Change in appetite(2. Decrease in pallor and fatigue)
研究者
Dr Asmita Ashokrao Bhadre
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar