A Phase 3 interventional study of Aloevera and Thyme honey in Xerostomia, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Ain Shams University · Phase 3, Interventional, and Supportive care
The objectives of the present study are to:
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
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.
254 studies on the registry are indexed under Xerostomia; 47 are open to participants now.
This study's planned enrollment of 45 is close to the median of 42 across 216 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Mouthwash
Mouthwash
Change in unstimulated Salivary flow rate
Milliliters
Time frame: Baseline, 2weeks and 4weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Ain Shams University