Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT05885906
Eligibility Criteria:
Inclusion Criteria:
1. Both gender, with type 2 diabetes mellitus only and suffering from xerostomia.
2. Patients willing to follow all the instructions and attend all the study-associated visits.
Exclusion Criteria:
1. Patients who had received radiation therapy to the head and neck region.
2. Patients with other systemic diseases known to cause xerostomia (Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, hepatitis C virus, tuberculosis, or sarcoidosis).
3. Patients using any other medication for their dry mouth condition (pilocarpine, cevimeline) 7 days before entering into the study.
4. Patients requiring hospitalization for any medical problem during the study.
5. Known hypersensitivity to the active ingredient of the product that will be used as assessed by the medical history questionnaire.
6. Vulnerable groups such as mentally or physically handicapped individuals, pregnant females, prisoners.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05885906
Study Brief:
Protocol Section:
NCT05885906