CTRI/2024/05/067003
Not yet recruiting
Phase 2/3
A Randomized clinical controlled trial on speech fluency disorders in children with combination of Anutail Nasya and Vagshudhikar Churna
Dr shubhangi thakur1 site in 1 country70 target enrollmentStarted: May 23, 2024Last updated:
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Dr shubhangi thakur
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- evaluation of dysfluencies during reading and conversation by using 100 word sample method
Overview
Brief Summary
This study is randomized clinical controlled trial comparing the saftey and efficacy of combination of vagshudhikar churna doses for patient according to age for three months with Anu tail Nasaya 3cycles of 21 days and another group will be with only speech therapy in age 2 to 12 years of age children the primary outcome measures will be evaluation of dysfluencies during reading at 6 weeks the secondary outcome will be overall effectiveness and better approach towards the treatement of fluency disorders at 12 weeks
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •children of the age group of 2 -12 Years Speech related problems in consequence with delayed developmental Milestones.
Exclusion Criteria
- •Suffering from sensory aphasia or dysphasia Children suffering from cleft palate& Cleft lip or the conditions where the surgical intervention is required Speech disorders secondary to disorders like cerebral palsy are excluded Speech disorders which are complicated with other systemic disorders Children suffering from Dysphonia & Dysarthria.
Outcomes
Primary Outcomes
evaluation of dysfluencies during reading and conversation by using 100 word sample method
Time Frame: 6 weeks
Secondary Outcomes
- efectiveness of treatement and better approach towards modification of treatement on fluency disorders(12 weeks)
Investigators
Dr Shubhangi thakur
Government Ayurved college Osmanabad
Study Sites (1)
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