- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240806
Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia
Efficacy of Manuka Honey Oral Rinse in Treatment of Xerostomia in Elderly: A Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Xerostomia has a variety of possible etiological factors; it is generally classified as having primary and secondary causes. Primary causes comprise conditions that directly affect the salivary glands and induce xerostomia like, Sjogren's syndrome, diabetes mellitus type 1 and 2, thyroid disease, adrenal pathology, renal or hepatic diseases, hepatitis C virus infection, and HIV disease.
Secondary causes of xerostomia include the side-effects of radiation therapy or chemotherapy, rheumatoid arthritis, scleroderma, mixed connective tissues diseases, systemic lupus erythematous, graft versus host disease, anorexia, alcohol and smoking and commonly prescribed drugs (>500 medications reportedly cause dry mouth). The most common medications causing hyposalivation are those with anticholinergic activity, sympathomimetic, and benzodiazepines. The risk of xerostomia increases with the synergistic effects of xerogenic medications, multiple medications, higher doses of medication, and the duration of the medication.
Honey was found to have several benefits as an alternative medicine, it has been used as a natural medicine for more than 2000 years, mainly for wound healing. Though there are many varieties of honey, only some of them e.g. Manuka honey and Malaysian Tualang honey, have been studied in detail for their medicinal properties.
Manuka honey is a monofloral honey, produced from the nectar of flowers of Manuka tree. This variety is produced from the Apis mellifera honey bees, using New Zealand Manuka plants producing specific floral-variety named as Leptospermum scoparium. The composition of Manuka honey consists of carbohydrates, minerals, proteins, fatty acids, phenolic and flavonoid compounds. Although such compounds are found in other types of honey, other unique features also occur in Manuka honey, such as an unusually high level of methylglyoxal (MGO) formed from dihydroxyacetone (DHA) which correlates with antibacterial activity.Manuka honey shows antioxidant and anticancer properties, which are considered due to its constituents-phytochemicals working as active bio-compounds.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 3753450
- The British university in Egypt
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Both genders, aged above 65 years.
- All patients must have complaint of xerostomia.
- Patients must be able to make reliable decision or communications.
Exclusion Criteria:
- - Smoking, Alcohol.
- Patient with history of any serious illness as malignancy.
- Patients with any autoimmune disease.
- Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
- Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Manuka honey interventional arm
Manuka honey used as mouth rinse in treatment of xerostomia
|
Manuka honey will be topically applied to the oral mucosa as oral rinse based on the Biswal et al., 2003 administration protocol.
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Placebo Comparator: Saline mouthwash control group
Saline used as mouth rinse for xerostomia
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Saline mouthwash will be used 3 times per day for one month
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in subjective dry mouth score
Time Frame: one month
|
changes in subjective dry mouth score [Time frame: baseline, 2 weeks, and 4 weeks] after manuka honey mouth rinse use higher number scores mean worse diagnosis while lower values mean better prognosis
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in objective dry mouth score
Time Frame: one month
|
changes in objective dry mouth score [Time frame: baseline, 2 weeks, and 4 weeks] after manuka honey mouth rinse use higher number scores mean worse diagnosis while lower values mean better prognosis
|
one month
|
Increase in Unstimulated Salivary flow rate (ml/min)
Time Frame: one month
|
Eating and talking were prohibited during the time of collection.
Unstimulated whole saliva was collected for 5 min by spitting method.
The collection will be timed, so that flow rate (mL/min) could be measured As the salivary flow rates increased it means improvement
|
one month
|
Changes in salivary potential of hydrogen ion (pH)
Time Frame: one month
|
following saliva collection, pH was measured immediately using the narrow-range pH strip system (Merck). One drop of the collected saliva was placed on the test strip and its color change reflected the pH of the saliva. As salivary pH increased it means improvement |
one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-061
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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