Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics (A Randomized Controlled Clinical Trial With Biochemical Analysis)

FDASU-RecIM122208

The objectives of the present study are to: 1. Compare the clinical efficacy of (50%) aloe vera versus (20%) thyme honey mouthwash on management of xerostomia in diabetic patients by measuring the salivary flow rate as a primary objective. 2. Asses the biochemical effect of aloe vera and thyme honey on the level of salivary nitric oxide, xerostomia grade as well as patient quality of life as a secondary objective. Research question: Which is better aloe vera or thyme honey in improving salivary flow rate in diabetic patients suffering from xerostomia? Patient Grouping and Randomization: Patients with xerostomia will be randomly distributed into three groups using a computer-generated randomization table. Allocation concealment will be achieved by a sealed opaque envelope with a ratio of 1:1:1 Group 1 (Aloe Vera group) Include (15) patient suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash Group 2 (Thyme honey group): Include (15) patient suffering from diabetes induced xerostomia that will receive thyme honey mouthwash Group 3 (Saline control group): Include (15) patient suffering from diabetes induced xerostomia that will receive saline mouthwash

2023-07-24

2023-10-01

2024-03-01

Active (not recruiting)

Early phase I

45

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

2023-09-14