The Efficacy of Thyme Honey Mouth Rinse on Polypharmacy-induced Xerostomia (A Randomized Controlled Clinical Trial With a Biochemical Assessment)

Thyme Honey Mouth Rinse

The study is designed to evaluate the clinical efficacy of thyme honey as a mouth rinse in the management of polypharmacy-induced xerostomia concerning the unstimulated whole salivary flow rate and quality of life of patients along with a biochemical assessment of salivary nitric oxide levels.

2024-01-01

2024-03-01

2024-04-01

Not yet recruiting

Early phase I

32

Inclusion Criteria: 1. Both genders, aged between 40 and 65 years old. 2. Patients using two or more medications known to cause xerostomia or salivary hypofunction (e.g., anxiolytics, anorexiants, anti-asthmatics, anticholinergics, anti-depressants, anti-emetics, anti-histamines, antihypertensives, anti-parkinsonians, anti-psychotics, antithrombotics, muscle relaxants, anticonvulsants, decongestants, diuretics, NSAIDs, or sedatives). Patients taking previous drugs for 240 days or more before the start of the trial and expected to continue. 3. Patients are 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 (diabetes mellitus, 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 pregnant females, prisoners, and mentally or physically handicapped individuals.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '0.2% thyme honey mouth rinse as intervention', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}

2024-01-12