Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
Conditions
Interventions
Intervention1: Combined Oral Glycoprrolate Tablets and behavioural therapy: INTERVENTION GROUP WILL RECEIVE Glycopyrrolate along with Behavioural therapy for total duration of 3 months
•The medicati
Sponsors
Rathod Prashant Narayan
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1)To determine the most effective dosing schedule to achieve the optimum balance between clinical benefits & adverse effects in two groups. 2)To describe the reported satisfaction with medication treatment of drooling for children & carers. 3)To study the adverse effects of glycopyrrolate in two groups.Timepoint: At baseline, 4 Weeks & 12 Weeks | — |
Countries
India
Contacts
Public ContactSmita Madusudan Mundada
Government Medical College Chhatrapati Sambhajinagar
Outcome results
None listed