CTRI/2025/02/081392尚未招募2/3 期
A Randomized Control Clinical Study to Evaluate The Efficacy of Saraswata Churna in Vak-Graha (Stuttering) in Children
Institute for Ayurved Studies and Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月15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
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome will measure change in the clinical symptoms of Stuttering.
研究概览
简要总结
A randomized clinical trial has been designed to assess the efficacy of Saraswata churan with speech thearpy in the management of Vak-Graha in children of age group 4 year to 12 year is selected from O.P.D. of Kaumarbhritya Department of Institute for Ayurved Studies and Research
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
- 4.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children in between the age group of 4- 12 years of either sex irrespective of caste, religion and socio-economic status.
- •Any pauses, repetition, prolongation of vowels or words.
- •Slurring of words and distortion of vowels because of lack of strength and muscular control, causing dysfluency in speech.
排除标准
- •Patient suffering from sensory aphasia or dysphasia.
- •Patient suffering from cleft palate & cleft lip or the conditions where the surgical intervention is required.
- •Speech disorders secondary to disorders like cerebral palsy etc.
- •Speech disorders which are complicated with other systemic disorders.
- •Patient suffering from Dysphonia & Dysarthria.
结局指标
主要结局
The primary outcome will measure change in the clinical symptoms of Stuttering.
时间窗: 60th day
次要结局
- Change in score of Stuttering severity instrument-3 to assess the efficacy of selected drug.(Assessment of the safety of the drug by documenting the occurrence of any adverse drug)
研究者
Dr Rohit Kumar
Institute for Ayurved Studies and Research
研究点 (1)
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