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A clinical study of ultrasound-guided botulinum toxin A into salivary gland for sialorrhea after True Bulbar Palsy

A clinical study of ultrasound-guided botulinum toxin A into salivary gland for sialorrhea after True Bulbar Palsy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095859
Enrollment
Unknown
Registered
2025-01-14
Start date
2024-03-12
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

sialorrhea after True Bulbar Palsy

Interventions

Experimental group:30IU botulinum toxin per submandibular gland and 20IU botulinum toxin per parotid gland on both sides
Control group:Inject equal doses of placebo (physiological saline)

Sponsors

Fuxing Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18-80 years old; 2. Head MRI or CT confirms the presence of medullary lesions (bleeding, ischemia, and tumors); 3. After conducting a flexible endoscopic evaluation of swallowing (FEES), it was confirmed that there were swallowing disorders; 4. Accompanied by salivation, if the total score of the drooling severity and frequency scale (DSFS-T) is >= 4 points, or if each item of the drooling severity and frequency scale (DSFS) scores >= 2 points, or if the Murray secretion scale (MSS) score of the throat is >= 2 points, meeting any one of the above three criteria is considered to have salivation; 5. Clear consciousness, able to cooperate with drooling assessment and follow-up; 6. Agree to receive BTX-A injection, provide informed consent for this study, and sign relevant documents;

Exclusion criteria

Exclusion criteria: 1. having received BTX-A injection therapy in the past six months; 2. Allergic or contraindicated to botulinum toxin; 3. Have taken medication for the treatment of drooling or medication that can cause drooling in the past month; 4. Serious heart, lung, liver, kidney and other important organ diseases or malignant tumors; 5. Simultaneously using aminoglycoside antibiotics and warfarin: 6. Patients with infection or skin lesions at the injection site, or severe muscle atrophy or infection at the injection site, as well as those with infection or skin lesions at the injection site, or severe muscle atrophy or infection at the injection site.

Design outcomes

Primary

MeasureTime frame
Global Impression of Change Scale;Murray secretion scale MSS;Hamilton depression scale,HAMD;

Secondary

MeasureTime frame
DSFS-S andDSFS-F;pneumonia;

Countries

China

Contacts

Public ContactHou Yajing

Fuxing Hospital affiliated to Capital Medical University

hyj052160@mail.ccmu.edu.cn+86 88062907

Outcome results

None listed

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