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临床试验/CTRI/2025/08/092437
CTRI/2025/08/092437尚未招募2/3 期

Evaluation of saraswata churna and samvardhana ghrita on speech in cerebral palsy - A Randomized controlled clinical trial

KLE Ayurveda Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月1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
Measured by changes in Viking Speech Scale

研究概览

简要总结

Cerebral Palsy is a group of permanent disorders of movement and posture. It may develop into a range of secondary conditions over time that will variably affect functional abilities, such as disturbed neuromuscular control of speech mechanisms, often resulting in communication disorders especially poor speech production in patients with CP. Cerebral palsy (CP) is the most common cause of motor disability worldwide, with a prevalence of 2 to 2.5 per 1000 live births. Due to non-progressive disturbances in the developing fetal or infant brain, it causes limitation of activity. Cerebral Palsy is physiologically classified into four main types: Spastic, Dyskinetic, Ataxic, or Mixed. Of all these, Spastic Cerebral Palsy is the most common.

Several comorbidities distinguish the clinical picture of children with CP, such as communication impairment, feeding difficulties, intellectual disability, vision and hearing impairment, and epilepsy. Communication difficulties in CP include altered phonation, low speech intelligibility, abnormal development of gesture and facial expression, and receptive and expressive language impairment. Communication impairment has been identified in at least 40% of children with CP. About 36 to 90% of children undergo motor speech impairments. The treatment of speech usually depends on the severity and includes speech therapy and physical exercises that focus on strengthening the muscles involved in speech.

Oral muscle relaxant drugs such as diazepam, baclofen, and dantrolene may have side effects like impaired memory, confusion, attention deficits, ataxia, and weakness.

Saraswata churna and Samvardhana ghrita are formulations mentioned by Acharyas in Sahasrayoga and Kashyapa Samhita respectively. These are indicated in conditions like vakgraha, muka, and swara sanshtana roga. Such properties may help improve speech in cerebral palsy.

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
3.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Patients with cerebral palsy of either sex in age group between 3years to 16 years Patients fulfilling the diagnostic criteria will be included for the study Children who have previous MRI report which is suggestive of diagnosis of cerebral palsy.

排除标准

  • Children with any chronic or acute other systemic illness Known cases of primary aphasia Children who are known cases of deaf mutism At the time of enrolment if the child is found to be non inclusive due to underlying health condition or medication which may interfere with study outcome like cleft lip cleft palate muscle relaxants anti-epileptics Children with conditions that are contraindicated for nasya.

结局指标

主要结局

Measured by changes in Viking Speech Scale

时间窗: 0 day | 15 thday | 30 thday

次要结局

  • Measured by changes in communication function classification system and parameters of vakpravritti(0 th day)

研究者

发起方
KLE Ayurveda Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shinde Samrudhi Vishwas

KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya

研究点 (1)

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