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临床试验/CTRI/2024/07/071289
CTRI/2024/07/071289尚未招募2/3 期

Randomised clinical study to evaluate the efficacy of Rudraksha lehana as an add-on to speech therapy in language disorders of pre-school children

Principal investigator1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
1 To asses the effect of Rudraksha and speech therapy as per the scores of REELS COMDEALL and ALD scales

研究概览

简要总结

Language disorders /Specific language impairment is characterised by significant variation between the cognitive level and language level. They follow an atypical pattern of language acquisition and use. As per The Federal Individuals with Disabilities Education Act requires early intervention and special education i.e, Speech-Language therapy in such conditions. Language therapy focuses on expanding vocabulary and understanding of semantics, improving syntax and pragmatic. As per the recent evidences, Speech-Language therapy is the choice of treatment for language disorders and these therapies take almost more than 6 months of time period to show any effect. There are currently no pharmacological interventions that treat language disorders.

In Ayurveda classics*,production of speech is said to be one of the prime functions of Vata Dosha and in sub type of Vata it is of Udana Vata.Avak’ (inablity to speak words) and ‘Vakya Rahita’ (inablity to speak in sentences)are the two terms indicating speech related problems as per Ayurveda. Based on the principles of Ayurveda, Rudraksha* can be used for speech delay as it has properties like Vata-Kapha hara, which is the main cause of speech disorders according to Acharya Sushrutha. Hence, based upon the above available references the following study has been designed to understand the role of Ayurveda treatment modality in Language disorders of pre-school childern .

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
2.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Children in between the age group of 2-6 years irrespective of gender, religion and socioeconomic status.
  • Children diagnosed with language disorders
  • (ICD-10-CM F80.9).

排除标准

  • Known cases of systemic disorders which may interfere with the course of study.
  • Known cases of any congenital anomalies and syndromes affecting speech.
  • Children with generalized cognitive disorders, neuromotor conditions, speech sound disorders and childhood-onset fluency disorders.

结局指标

主要结局

1 To asses the effect of Rudraksha and speech therapy as per the scores of REELS COMDEALL and ALD scales

时间窗: base line | 6th week

次要结局

  • 1 To study the effect of Speech Language therapy in language disorders as per the scores REELS COMDEALL & ALD scales(2 To Compare the effect of both the groups in language disorders as per the scores REELS COMDEALL & ALD scales)

研究者

申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vaishnevi Kannan Velu

JSS Ayurveda Medical College and Hospital

研究点 (1)

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