跳至主要内容
临床试验/CTRI/2025/04/085298
CTRI/2025/04/085298尚未招募2 期

Randomized Controlled Trial To Evaluate The Efficacy Of Lakshadi Taila Abhyanga For Weight Gain In Low Birth Weight Neonates Greater Than Or Equal to 35 Weeks Gestational Age

Harshada Sanjay Sonawane1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月29日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To Evaluate The Effect Of 10ml Lakshadi Taila Abhyanga At Morning And Evening In Low Birth Weight Neonate More Than 35 Weeks Of Gestational Age

研究概览

简要总结

This Study Is An Open Labelled Randomised Controlled Clinical Trial Comparing The Safety And Efficacy Of Lakshadi Taila In A  Sufficient Quantity (10ML) For Local Application And Controlled Drug Simyl MCT Oil  In A  Sufficient Quantity (10ML) For 15 Days In 70 Patients Of Low Birth Weight Neonate Greater Than Or Equal To 35 Weeks Gestational Age For Weight Gain.

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
0.00 Day(s) 至 28.00 Day(s)(—)

入选标准

  • Neonate Weighing Between 1.5 To 2.5 Kg Of Birth Weight, Neonate Between The Ages From Birth To 28 Days Irrespective Of Gender,Cast, Religion, Socio-economic Status, Gestational Age More Than Or Equal To 35 Weeks.

排除标准

  • Neonate Associated With Skin Conditions Like Open Wound, Severe Eczema, Dermatitis, Sepsis, Any Congenital Anomalies Like Spina Bifida, Diphragmatic Hernia, Anencephalya, In Born Error Of Metabolism Like Phenylketonuria, Maple Syrup Urine Disease, Galactosemia, Systemic Diseases Like Necrotizing Enterocolitis, Broncho Pulmonary Dysplasia, Meningitis, Neonate With Pathological Jaundice.

结局指标

主要结局

To Evaluate The Effect Of 10ml Lakshadi Taila Abhyanga At Morning And Evening In Low Birth Weight Neonate More Than 35 Weeks Of Gestational Age

时间窗: 15 days

次要结局

  • Determine The Impact Of Lakshadi Taila Abhyanga On Skin Health In Low Birth Weight Neonate , To Assess The Impact Of Lakshadi Taila Abhyanga On Maintaining Stable Body Temperature In Low Birth Weight Neonate, Evakuate The Safety Of Lakshadi Tail Abhyanga In Low Birth Weight Neonate.(15 days)

研究者

发起方
Harshada Sanjay Sonawane
申办方类型
Other [self]

研究点 (1)

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