An interventional study of HA formulation Oral Spray and Placebo in Dry Mouth, Xerostomia and Type 2 Diabetics, sponsored by You First Services. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-10.
Sponsored by You First Services · Not applicable, Interventional, and Treatment
An increased incidence of dental caries in association with poorly controlled diabetes has also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of patients with diabetes, Without adequate saliva production, both hard and soft tissues of the mouth can be severely damaged and become more susceptible to infections. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of HA formulation in alleviating dry mouth in type 2 diabetic patients.
286 studies on the registry are indexed under Xerostomia; 51 are open to participants now.
This study's enrollment of 30 is below the median of 44 across 235 interventional studies indexed under Xerostomia.
Browse Xerostomia studies →You First Services is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
Device: HA formulation Oral Spray
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
Device: Placebo
It is an HA formulation of FDA listed ingredients
Placebo formulation without the active ingredients
Relief from drymouth using VAS scoring
Patients' perception of efficacy of a new mouth spray for 9 weeks in reducing the symptoms of drymouth in diabetic patients using VAS scoring
Time frame: 9 weeks
Ran from Jan 2018 to primary completion in Oct 2019, 21 months.
Of 101 interventional studies with no phase under Xerostomia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 33. This study's 21 months is above that.
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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You First Services