Randomized open - label clinical study on the efficacy of Lohagudhadi Gutika in Rasapradoshaja pandu with special reference to iron deficiency anemia in children with comparison to the efficacy of Punarnava mandura
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Iron deficiency anemia remains highly prevalent among children due to increased nutritional demands during growth.
Untreated IDA can cause impaired growth, cognitive deficits, and reduced academic performance. Although conventional iron supplements are effective, their gastrointestinal side effects often lead to poor compliance in children. Lohagudhadi Gutika, an Ayurvedic formulation containing Mandura Bhasma and Triphala, is traditionally indicated for anemia and is considered safe and well tolerated in children, but lacks scientific evaluation. Hence, this study aims to assess the efficacy, safety, and tolerability of Lohagudhadi Gutika in Rasapradoshaja Pandu (Iron Deficiency Anemia) in pediatric age group, in comparison with the standard control drug Punarnava Mandura.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants between the age group of 15years.
- •18years irrespective of their religion, gender and socio-economic status.
- •Participants presenting with the clinical features of mild to moderate anemia and haematocrit value less than 36% will be included.
- •Participants with clinical features of Rasapradoshaja Pandu roga.
- •Participants with cardinal signs of iron deficiency anemia.
- •Participants whose parents are willing to sign the written consent form and follow the protocol.
排除标准
- •Children with Hb% less than 7 g/dl (severe anemia).
- •Children with congenital anomalies, inborn errors of metabolism and with the evidence of any malignancy will be excluded.
- •Children with hepatic, renal dysfunction, chronic systemic illness and other hemoglobinopathies will be excluded.
- •History of hypersensitivity to any ingredient used in the medicinal preperation.
研究者
Dr Rachana J
Sri Sri College of Ayurvedic Science and Research, Bangalore.