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临床试验/CTRI/2024/10/074975
CTRI/2024/10/074975招募中2/3 期

Evaluation Of Rajanyadi Churna In Management Of Pandu w r t Iron Deficiency Anemia In Adolescents – A Randomised Controlled Clinical Trial

Dr Savita Sunadholi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
measured by changes in HB%

研究概览

简要总结

Iron deficiency anemia (IDA) is the most frequent hematological and nutritional disorder of childhood and adolescence which is the commonest form of anemia.1 Approximately 25% of people worldwide have anemia. Iron deficiency, the most common cause, is responsible for 50% of all anemia.2 Data from the NFHS5 shows that 57% Indian adolescent girls and 31% boys are anemic. The prevalence of anemia has remained unchanged over the last 3 decades.3 Iron deficiency anemia can cause diminished growth and learning and have serious consequences such as Congestive cardiac failure, splenomegaly in children which indirectly affecting the quality of life in children.4

The widely used medications for treating IDA are oral iron preparations (ferrous fumarate etc.) which have adverse effects such as nausea, epigastric distress, decreased appetite, flatulence, constipation or diarrhea.5 The adverse effect of Intravenous iron therapy such as Extravasation of iron solutions into the subcutaneous tissue which causes brownish stains that can be permanent and aesthetically unpleasant for the patient.6

Therefore there is a need to overcome the consequences of iron therapies and to help in improving the growth and cognitive deficits caused by IDA. In Ayurveda there are various formulations known for their efficacy in treating Pandu roga with their karmas like Deepana, Pachana, Srotoshodhana, Rasa Dhatu prasadaka. One such preparation is Rajanyadi churna, which is mentioned in Pandu roga. Therefore, this study is taken to address the management of Pandu roga in children with Rajanyadi churna .

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
10.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Children of either sex from age 10 to 16 years Children with mild and moderate severity of anemia according to WHO Hb threshold Children fulfilling the diagnostic criteria.

排除标准

  • Children having any other known type of anemia except IDA Children having IDA with any associated severe complication like CCF,Splenomegaly etc.
  • Children with severe developmental disabilities such as autism, cerebral palsy etc.
  • Children with any known pathology associated with kidney, liver etc Children with any known bleeding disorders, genetic disorders, metabolic disorders etc Children who have received any form of supplements for IDA in last 1 month.

结局指标

主要结局

measured by changes in HB%

时间窗: 0 day | 15 day | 30 day

次要结局

  • measured by changes in Peripheral Smear and lakshana’s of Pandu through gradings(0 day)

研究者

发起方
Dr Savita Sunadholi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Savita Sunadholi

KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka

研究点 (1)

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