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临床试验/CTRI/2025/01/078874
CTRI/2025/01/078874尚未招募2/3 期

A Randomized Controlled Clinical Study To Evaluate The Effect Of Sthiradi Ghrita And Hyderabad Mix On Karshya In Children Of Age 1-6 Years

Dr Pooja Vijayprakash chaubey2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年2月12日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
250
试验地点
2
主要终点
Sthiradi Ghrita more effective than Hyderabad mix in management of Karshya in children of age group 1-6 years.

研究概览

简要总结

In India 35.3% of total population falls under the pediatric age group. They  are prone to various health problems and considered as special risk group. Among the various diseases they suffer the underlying cause most of the times is Undernutrition. This study is Randomized clinical controlled trial. Primary objective of this study is to evaluate the effect of Sthiradi Ghrita over Hyderabad mix in management of Karshya( undernutrition) in children of age 1-6 years. Secondary objectives of this study are to compare the effect of Sthiradi Ghrita with Hyderabad mix in Karshya, to study add on effect of Shtiradi Ghrita with Hyderabad mix against Hyderabad mix alone in Karshya and to study adverse effects of Sthiradi Ghrita if any. This study is divided in 3 groups. group A - Sthiradi Ghrita per oral twice a day for 45 days with Hyderabad mis as per energy requirement and dietary advice. Group B - Sthiradi Ghrita per oral twice a day day along with dietary advice. Group C - Hyderabad mix as per energy requirement for 45 days along with dietary advice. follw up on day 7th, 15th, 30th and 45th day of treatment and after completion on 75th day will be taken.  sample size - considering a drop out of 30% minimum 250 patients will be enrolled in the study. this study is aimed at completing 75 pstients in each group.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
1.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Children in the age group 1-6 years irrespective of sex, and religion.
  • Children with gade 1 and 2 i.e, with mild and moderate malnutrition accorging.

排除标准

  • Severely malnourished children- grade 3 and 4 according to IAP classification.
  • Children with active systemic or surgical illness.
  • Children with chromosomal, congenital, metabolic or genetic disorders.

结局指标

主要结局

Sthiradi Ghrita more effective than Hyderabad mix in management of Karshya in children of age group 1-6 years.

时间窗: 45days

次要结局

  • Sthiradi Ghrita with Hyderabad mix has an add on effect than Hyderabad mix alone in management of Karshya in children of Age 1-6 years(45days)

研究者

发起方
Dr Pooja Vijayprakash chaubey
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Pooja Vijayprakash Chaubey

Tilak Ayurved Mahavidyalaya

研究点 (2)

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