A Randomized Open Labeled Controlled Clinical Trial To Evaluate The Efficacy Of Darvyadiloham In Pandu With Special Reference To Iron Deficiency Anemia In Children (6-13 years)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- To evaluate the clinical efficacy of Darvyadiloham in increasing hemoglobin percentage in the management of Pandu in children.
研究概览
简要总结
Anemia is a condition in which the number of red blood cells and consequently their oxygen carrying capacity is insufficient to meet body’s physiological needs. India is one of the countries with very high prevalence of anemia in the world. The NFHS 3 data suggesting that anemia is widely prevalent among all age groups with overall prevalence of 50% in school aged children. Anemia has been described many years ago by the name of Panduroga in Ayurveda. Ayurveda documents large number of preparations for management of Pandu of which Darvyadiloham from Rasendrasarsangraha is selected for present study.
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
- 6.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with iron deficiency anemia (Hb 8gm%-11gm%) 2)Patients with classical sign and symptoms described in Charak Samhita Adhyaya
- •Patients whose parents are willing to give consent for clinical trial.
排除标准
- •Patients suffering from systemic illness necessitating long term treatment.
- •Patients with other causes of anemia like thalassemia, sickle cell anemia, aplastic anemia, hemolytic anemia, anemia due to blood loss.
- •Patients with k/c/o malignancy.
- •History of hypersensitivity to any of the trial drug or their ingredients.
- •Patients who have completed participation in any other clinical trial during the past six months.
结局指标
主要结局
To evaluate the clinical efficacy of Darvyadiloham in increasing hemoglobin percentage in the management of Pandu in children.
时间窗: Assessment after 56 days.
次要结局
- To assess the symptomatic relief in clinical signs of Pandu namely Panduta, Hritspandan, Akshikutshotha, Daurbalya, Shrama etc.(To assess the change in hemoglobin & peripheral blood smear.)