Study of role of Behavioural Therapy in addition to Glycopyrrolate in The Treatment of excessive salivation in Children With Mental Disabilities
Phase 4
- Conditions
- Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
- Registration Number
- CTRI/2024/05/066868
- Lead Sponsor
- Rathod Prashant Narayan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Children aged 3 years to 12 years with any Neurodevelopmental disorder such as cerebral palsy who require treatment for drooling
2) Weight more than or equal to 10 kg
Exclusion Criteria
1) Children who have received medical or surgical interventions for drooling
2) Those parents/guardians who did not give consent
3) Any contraindications for glycopyrrolate like glaucoma , obstructive uropathy , gastrointestinal obstruction , severe ulcerative colitis and myasthenia gravis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of combined behavioural therapy and glycopyrrolate versus glycopyrrolate alone in the treatment of sialorrhea in children with neurodevelopmental disabiltiesTimepoint: At Baseline, 4 Weeks and 12 Weeks
- Secondary Outcome Measures
Name Time Method 1)To determine the most effective dosing schedule to achieve the optimum balance between clinical benefits & adverse effects in two groups. <br/ ><br>2)To describe the reported satisfaction with medication treatment of drooling for children & carers. <br/ ><br>3)To study the adverse effects of glycopyrrolate in two groups.Timepoint: At baseline, 4 Weeks & 12 Weeks