Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics

• Sponsor: Ain Shams University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05885906
• Collaborator: (none)
• Enrollment: 45
• Arms: 3
• Anticipated Duration (Months): 8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Xerostomia	Drug: Aloevera; Drug: Thyme honey; Drug: Saline	Phase 3

Detailed Description

Saliva is a complex mix from major as well as minor salivary glands and gingival crevicular fluids. It is a clear and slightly acidic diluted secretion with more than 99% water, electrolytes, immunoglobulins, enzymes, proteins, mucin and nitrogenous products. Subjective feeling of a dry mouth is known as xerostomia, which may result from diminished saliva production, but some people reported feeling a dry mouth even though there was no decrease in saliva quantity.Diabetes mellitus is considered one of the main causes of xerostomia There are different treatments modalities of xerostomia which include pharmacological and non-pharmacological treatments.Recently different herbs were used in the treatment of xerostomia and showed promising results and great patient acceptance among which aloe vera and thyme honey are used.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics (A Randomized Controlled Clinical Trial With Biochemical Analysis)
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aloevera group 15 patients suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash (20 ml of aloe vera 50%) 3 times per day for 4 weeks.	Drug: Aloevera; Mouthwash
Active Comparator: Thyme honey group 15 patients suffering from diabetes induced xerostomia that will receive thyme honey mouthwash (20 ml of thyme honey diluted in 100 ml of distilled water) 3 times per day for 4 weeks.	Drug: Thyme honey; Mouthwash
Placebo Comparator: Saline group 15 patients suffering from diabetes induced xerostomia that will receive saline mouthwash as a control group (20 ml of saline) 3 times per day for 4 weeks.	Drug: Saline; Mouthwash

Outcome Measures

Primary Outcome Measures

1. Change in unstimulated Salivary flow rate [Baseline, 2weeks and 4weeks]

   Milliliters

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

• Study Director: Radwa Rageb, PHD, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dina Borham Abdelhafez Abdellatif Elkhouly, Resident, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05885906
• Other Study ID Numbers: FDASU-RecIM122208
• First Posted: Jun 2, 2023
• Last Update Posted: Jun 2, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dina Borham Abdelhafez Abdellatif Elkhouly, Resident, Ain Shams University: Xerostomia; Aloevera; Thyme honey; type 2 diabetes
• Additional relevant MeSH terms: Xerostomia

Study Results

No Results Posted as of Jun 2, 2023