Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-28 @ 4:29 AM
Study NCT ID:
NCT05885906
Status:
UNKNOWN
Last Update Posted:
2023-09-14
First Post:
2023-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics (A Randomized Controlled Clinical Trial With Biochemical Analysis)
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: