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Comparison between an injection treatment of botulinum toxin A and an oral tablet glycopyrrolate in patients of cerebral dysfunction with complaints ofexcessive salivatio

Phase 1
Conditions
Health Condition 1: G80- Cerebral palsy
Registration Number
CTRI/2023/07/055549
Lead Sponsor
Institute of Postgraduate Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Confirmed case of cerebral palsy.

2.Drooling Severity (DS) Scale score 3 or more.

3.Drooling Frequency (DF) scale score 3 or more.

4.Consent from the guardian or relative

Exclusion Criteria

1.Local site infection. 2.Allergy to botulinum toxin type A or oral Glycopyrrolate.

3.H/O severe Dysphagia.

4.H/O surgery done for controlling of sialorrhea. Or any h/o of salivary gland excision surgery mainly parotid and submandibular. 5.Abnormal coagulation profile. 6.Patients suffering from unstable cardio vascular or serious respiratory diseases.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ltrasound guided botulinum toxin type A injection to salivary glands (b/l parotid & submandibular) versus otal glycopyrrolate in sialorrhea in cerebral palsy patients will be compared for efficacyTimepoint: 1 year
Secondary Outcome Measures
NameTimeMethod
Improvement of quality of life physically & psychologically following application of botulinum toxin type A injection over oral glycopyrrolate therapy will be compared.Timepoint: 1 year
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