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Antihistamine

50 mg Diphenhydramine for Heat Stroke

Phase 4

Recruiting

Research Sponsored by Lakehead University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or Female between ages 19 and 39 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for each study arm (all completed within 4 months), measured before heating, and at every 0.25c increase in core temperature (+0.25c, +0.50c, +0.75c, +1.0c, +1.25c, and +1.5c), or every ~15 minutes of (up to ~90 minutes) and immediately after heating

Awards & highlights

Study Summary

This trial aims to study whether common over-the-counter allergy medications affect how our bodies regulate temperature during times of heat stress. Allergic rhinitis, which affects about 25% of Canadians and is

Who is the study for?

This trial is for individuals with allergic rhinitis or hay fever who may experience heat stress. Participants should not have conditions like autonomic neuropathy that could affect body temperature regulation. The study excludes those taking other medications that might interfere with the results.Check my eligibility

What is being tested?

The study tests if common over-the-counter antihistamines (Diphenhydramine, Loratadine, Desloratadine) at normal doses affect the body's response to heat compared to a placebo. It aims to understand if these drugs increase the risk of heat-related illnesses.See study design

What are the potential side effects?

Possible side effects of antihistamines include drowsiness, dry mouth, dizziness and in some cases may impact how your body responds to heat which is what this trial intends to investigate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 19 and 39 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for each study arm (all completed within 4 months), measured before heating, and at every 0.25c increase in core temperature (+0.25c, +0.50c, +0.75c, +1.0c, +1.25c, and +1.5c), or every ~15 minutes of (up to ~90 minutes) and immediately after heating

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for each study arm (all completed within 4 months), measured before heating, and at every 0.25c increase in core temperature (+0.25c, +0.50c, +0.75c, +1.0c, +1.25c, and +1.5c), or every ~15 minutes of (up to ~90 minutes) and immediately after heating

This trial's timeline: 3 weeks for screening, Varies for treatment, and for each study arm (all completed within 4 months), measured before heating, and at every 0.25c increase in core temperature (+0.25c, +0.50c, +0.75c, +1.0c, +1.25c, and +1.5c), or every ~15 minutes of (up to ~90 minutes) and immediately after heating for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Heart Rate

Local Sweat Rate

Mean Arterial Pressure

+2 more

Secondary outcome measures

Mental Acuity

Sleepiness/Fatigue level

Thermal Comfort

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 50 mg DiphenhydramineExperimental Treatment1 Intervention

Group II: 5 mg DesloratadineExperimental Treatment1 Intervention

Group III: 10 mg LoratadineExperimental Treatment1 Intervention

Group IV: Placebo (Sugar pill)Placebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lakehead UniversityLead Sponsor

24 Previous Clinical Trials

3,977 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main goals being pursued in this research endeavor?

"The primary objective of this trial is to assess Skin Blood Flow. Measurements will be taken before and after the heating protocol for each study arm, with all assessments completed within a 4-month period. Secondary outcomes include Mental Acuity, which will be evaluated using the digital Stroop test; Sleepiness/Fatigue level, measured using the Stanford Sleepiness Scale (ranging from 1 to 7, where higher scores indicate greater fatigue); and Thermal Comfort, assessed through self-report on a four-point analog scale ranging from "Not uncomfortable" to "Very uncomfortable"."

Answered by AI

Are new participants currently being enrolled in this research study?

"Indeed, clinicaltrials.gov indicates that this study is presently actively seeking individuals to participate. The trial's initial posting occurred on December 5th, 2023, and the most recent editing took place on January 11th, 2024."

Answered by AI

What is the current number of participants being recruited for this research study?

"Indeed, as per the information available on clinicaltrials.gov, this ongoing study is actively seeking eligible participants. The trial was initially posted on December 5th, 2023 and last updated on January 11th, 2024. The research team aims to enroll a total of 16 patients across a single designated site."

Answered by AI

Has the Food and Drug Administration (FDA) granted approval for the use of Desloratadine at a dosage of 5 mg?

"Our team at Power rates the safety of 5 mg Desloratadine as a score of 3, considering it is being evaluated in a Phase 4 trial where the treatment has already received approval."

Answered by AI

Can individuals who have reached the age of 65 be considered as potential participants for this experiment?

"To be eligible for this study, potential participants must fall within the age range of 19 to 39 years old. It is worth noting that there are separate trials available for individuals under the age of 18 (consisting of 18 trials) and those over the age of 65 (comprising of 40 trials)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Over-the-Counter Antihistamines & Heat Stress

Nicholas Ravanelli 2023. "Over-the-Counter Antihistamines & Heat Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06217367.