Allergic Rhinitis Clinical Trial
— BENEXE2022Official title:
Does Diphenhydramine Alter Thermoregulatory Responses During Exercise?
Verified date | September 2023 |
Source | Lakehead University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In 2012, it was estimated that nearly 1 in 4 Canadians suffer from allergic rhinitis. To add, 78% of individuals working in predisposing environments are predicted to develop occupational rhinitis. Currently, the most popular treatment for rhinitis is antihistamine medication such as diphenhydramine, a first-generation antihistamine sold commercially as Benadryl®. Due it its anticholinergic effects, diphenhydramine has been suggested to impair the whole body sweating response during heat stress, potentially leaving consumers at an increased risk of heat-related illness. This randomized control trial approved by Health Canada will investigate whether ingesting extra strength diphenhydramine (50mg) will alter whole-body sweat losses during 60 minutes of exercise.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 23, 2023 |
Est. primary completion date | June 23, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 49 Years |
Eligibility | Inclusion Criteria: - Able to safely perform ~60 minutes of moderate intensity exercise - No known hypersensitivity to diphenhydramine - Not on any prescribed medication - Body-mass index (BMI) less than 30 Exclusion Criteria: - Outside 18 - 49 years of age - Diagnosed with any cardiovascular, respiratory, neurological or metabolic disease - History of any cardiovascular, respiratory, neurological or metabolic disease - Unable to exercise for 60 minutes at moderate intensity, or have a musculoskeletal injury - BMI > or = 30 |
Country | Name | City | State |
---|---|---|---|
Canada | Lakehead Unviersity | Thunder Bay | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lakehead University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Whole body sweat loss | Change in body mass from pre- to post-exercise corrected for respiratory and metabolic water losses using a digital platform scale accurate to +/- 2 grams. | Measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days | |
Secondary | Change in rectal temperature | Change in rectal temperature from pre- to post- exercise using a pediatric grade thermistor | Measured during both placebo and diphenhydramine intervention trials trials, separated by no more than 28 days |
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