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

NCT05885906 | Unknown Phase 3

• 1 other identifier: FDASU-RecIM122208
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the present study are to:

1. 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. 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.

Conditions

Xerostomia

Keywords

Xerostomia; Aloevera; Thyme honey; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Change in unstimulated Salivary flow rate

  Milliliters

  Baseline, 2weeks and 4weeks

Study Arms (3)

Aloevera group

ACTIVE COMPARATOR

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

Thyme honey group

ACTIVE COMPARATOR

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

Saline group

PLACEBO COMPARATOR

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

Interventions

Aloevera DRUG

Mouthwash

Aloevera group

Thyme honey DRUG

Mouthwash

Thyme honey group

Saline DRUG

Mouthwash

Saline group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Both gender, with type 2 diabetes mellitus only and suffering from xerostomia.
• Patients willing to follow all the instructions and attend all the study-associated visits.

You may not qualify if:

• Patients who had received radiation therapy to the head and neck region.
• Patients with other systemic diseases known to cause xerostomia (Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, hepatitis C virus, tuberculosis, or sarcoidosis).
• Patients using any other medication for their dry mouth condition (pilocarpine, cevimeline) 7 days before entering into the study.
• Patients requiring hospitalization for any medical problem during the study.
• Known hypersensitivity to the active ingredient of the product that will be used as assessed by the medical history questionnaire.
• Vulnerable groups such as mentally or physically handicapped individuals, pregnant females, prisoners.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of dentistry Ain shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Xerostomia; Diabetes Mellitus, Type 2

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Radwa Rageb, PHD

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 2, 2023
• Study Start: July 24, 2023
• Primary Completion: October 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)