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

Primary Purpose

Xerostomia

Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Aloevera
Thyme honey
Saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Xerostomia focused on measuring Xerostomia, Aloevera, Thyme honey, type 2 diabetes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Faculty of dentistry Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Aloevera group

Thyme honey group

Saline group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in unstimulated Salivary flow rate
Milliliters

Secondary Outcome Measures

Full Information

First Posted
May 22, 2023
Last Updated
September 12, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05885906
Brief Title
Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics
Official Title
Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics (A Randomized Controlled Clinical Trial With Biochemical Analysis)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objectives of the present study are to: 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. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
Xerostomia, Aloevera, Thyme honey, type 2 diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aloevera group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Thyme honey group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aloevera
Intervention Description
Mouthwash
Intervention Type
Drug
Intervention Name(s)
Thyme honey
Intervention Description
Mouthwash
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Mouthwash
Primary Outcome Measure Information:
Title
Change in unstimulated Salivary flow rate
Description
Milliliters
Time Frame
Baseline, 2weeks and 4weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radwa Rageb, PHD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of dentistry Ain shams university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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