se of the oral sialogogue, oryza tablet, in reducing drug-induced xerostomia in patients with overactive bladder or neurogenic bladder: randomized clinical study

Phase 3

Completed

• Conditions: Xerostomia in patients with overactive & neurogenic bladder receiving antimuscarinic drugs; xerostomia, overactive bladder, OAB, neurogenic bladder

• Registration Number: TCTR20240715015
• Lead Sponsor: Faculty of medicine Ramathibodi Hospital, Mahidol University

Brief Summary

Continuous daily use of Oryza tablet for 4 weeks reduced xerostomia symptoms and increased saliva production in patients suffering from neurologic bladder or overactive bladder who received antimuscarinic medications.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-01-05
• Study Start: 2024-07-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Overactive bladder and neurogenic bladder patient who use anticholinergic drug with xerostomia symptoms
Age 18 year old or older
Informed consent was made

Exclusion Criteria

Recently xerostomia symptoms within 3 months
History of head & neck radiation
Autoimmune disease
History of salivary gland surgery
Dental and oral infection
Uncooperative patient
History of drug allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Xerostomia symptoms 1 month Subjective dry mouth VAS

Secondary Outcome Measures

Name	Time	Method
Stimulated salivary flow rate 1 month Prohibited from eating and drinking for 60 mins before saliva collection. They chewed a paraffin cube for 30 seconds, then spit into a tube for 5 mis, after which the saliva volume was measured.