CTRI/2025/02/081392Not yet recruitingPhase 2/3
A Randomized Control Clinical Study to Evaluate The Efficacy of Saraswata Churna in Vak-Graha (Stuttering) in Children
Institute for Ayurved Studies and Research1 site in 1 country30 target enrollmentStarted: March 15, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The primary outcome will measure change in the clinical symptoms of Stuttering.
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 4.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The primary outcome will measure change in the clinical symptoms of Stuttering.
Time Frame: 60th day
Secondary Outcomes
- 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)
Investigators
Dr Rohit Kumar
Institute for Ayurved Studies and Research
Study Sites (1)
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