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

A comparative study on efficacy between ultrasound-guided botulinum toxin type a injection to salivary glands and oral glycopyrrolate therapy for management of sialorrhea in cerebral palsy - Nil

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055549

Enrollment

Registered

2023-07-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G80- Cerebral palsy

Interventions

Intervention1: Botulinum Toxin Type A: botulinum toxin type A injections under USG guidance by maintaining proper aseptic condition using 25/27 G needle with max 100 units of inj botulinum toxin type

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Ultrasound 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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactFirdaus Kamal

Institute of Postgraduate Medical Education and Research

kamal.firdaus.kamal@gmail.com9830219554

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026