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临床试验/CTRI/2025/01/079550
CTRI/2025/01/079550尚未招募2/3 期

A Comparative Clinical Study Of Vachadi Choorna And Kalyanaka Leha In The Management Of Speech Impairment(Mooka Minmina Gadgada) In Children

RaipurDepartment Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurveda College Raipur1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月7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
40
试验地点
1
主要终点
Reduces The Symptoms Of Speech Impairment.

研究概览

简要总结

Speech impairment is one of the common impairments presenting in early childhood.It can make the children difficult to communicate with other people and often affects a child’s quality of life.Mooka ,Minmina and Gadgada is mentioned in vatavyadhi avaran prakaran by acharya charak and acharya sushruta.In Astanga hridya uttartantra Acharya Vagbhata mentioned Vachadi churna for speech disorder.It has the properties of Anabhisyandi,Srotoshodhan Vatanuloman and vatakapha shamak which are the common treatment principle of avaran .The study is aimed to compare the efficacy of Vachadi churna and kalyanaka leha in the management of speech impairment in children.There will be 2 group each consist 20 patients.The study drug will be given to the intervention group and the standard drug will be given to the comparator group, in the form of leha ,oral (over the tongue) according to Young’s formula twice a day for 2 month.Post treatment follow up will be done in every 15 days for 1 month. Assessment  will be done on the basis of subjective and objective criteria adopted  for this study.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 12.00 Year(s)(—)

入选标准

  • 1.Patients with age group 3 years to 12 years.
  • 2.Children with clinical manifestations of speech impairment with and without cerebral palsy and other neurobehavioral disorders.
  • 3.Patients will be selected irrespective of Gender,religion,socioeconomics status.

排除标准

  • 1.Patients below 3 years and above 12 years.
  • 2.Children suffering from congenital,genetic disorder.
  • 3.Patients suffering from mouth ulcer,cleft palate & cleft lip,tongue tie or the condition where the surgical intervention is required.
  • 4.Speech disorders with other systemic disorders(nephrotic syndrome,diabities mellitus etc.).

结局指标

主要结局

Reduces The Symptoms Of Speech Impairment.

时间窗: Intervention of medicine for 2 month and post treatment follow up after 1 month.

Helps in the Achieving of Language Milestones

时间窗: Intervention of medicine for 2 month and post treatment follow up after 1 month.

次要结局

  • Improve the quality of life of child and parents

研究者

发起方
RaipurDepartment Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurveda College Raipur
申办方类型
Other [Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G)]
责任方
Principal Investigator
主要研究者

Dr Chandani Sahu

Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.)

研究点 (1)

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