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临床试验/CTRI/2025/10/096706
CTRI/2025/10/096706尚未招募2/3 期

A CLINICAL STUDY TO EVALUATE THE EFFICACY OF MAHASARASVATI CHURNA IN SPEECH DISORDERS(MOOKA AND GADGADA)IN PEDIATRIC AGE GROUP

Department Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurved College Raipur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月9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
Reduce The Symptoms of Speech Impairment Helps in Achieving of Language Milestone

研究概览

简要总结

Speech disorder is a critical barometer of both cognitive and emotional development. Language development occurs most rapidly between 2 to 5 years of age. During this period of learning of speech, usually child begins repetition of consonants, often followed by repetition of words. If this condition continues then child suffers from disability of speech.This clinical study is designed to evaluate the efficacy of Mahasarasvati Churna in the management of pediatric speech disorders, specifically Mooka (speech impairment) and Gadgada (stammering), as described in Ayurveda. Eligible children within the pediatric age group presenting with speech disorders will be enrolled and administered Mahasarasvati Churna for a defined treatment duration. 3 month (2 month for oral medication and 1 month for post treatment follow up )The primary outcome will be improvement in speech clarity, fluency, and communication skills. Secondary outcomes will include changes in associated behavioral, cognitive, and developmental parameters. The study aims to generate clinical evidence to support the role of Mahasarasvati Churna in enhancing speech development and communication ability in children.

Mahasarasvati Churna is a classical Ayurvedic formulation described in the text Rasa Ratna Samuchaya (Chapter 24). The formulation has also been included in the Ayurvedic Formulary of India (AFI), which authenticates its standard composition and therapeutic applicability. Its mention in both classical and official references highlights its traditional significance and contemporary relevance for clinical use in managing neurological and speech-related disorders.

This is a randomized,single arm open label study. A total of 30 pediatric patients will be enrolled and allocated into two groups based on the type of speech disorder: Mooka and Gadgada, with 15 patients in each group. All patients in both groups will receive Mahasarasvati Churna in Leha form. The study aims to evaluate and compare the clinical efficacy of Mahasarasvati Churna in Leha form between the two types of speech disorders to determine in which condition it is more effective.

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

入选标准

  • 1 Patients age group 1- 6 years 2 children with clinical manifestation of speech impairment with and without cerebal palsy and autism 3 patients will irrespective of gender , religion.

排除标准

  • 1 patients below 1 years and above 6 years 2 child suffering from congenital , genetic disorders 3 patients suffering from cleft palate and cleft lips, tongue tie or the condition where the surgical intervention required.

结局指标

主要结局

Reduce The Symptoms of Speech Impairment Helps in Achieving of Language Milestone

时间窗: Intervention of medicine for 3 month | (2 month for oral medication and 1 month for post treatment follow up

次要结局

  • Imrpove the Quality of Life of child and parents(Intervention of medicine for 3 month)

研究者

发起方
Department Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurved College Raipur
申办方类型
Other [Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010]
责任方
Principal Investigator
主要研究者

Dr Rahul Yadav

Shri Narayana Prasad Awasthi Government Ayurved college And Hospital Raipur Chhattisgarh

研究点 (1)

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