A double-blinded randomised controlled trial of the effects of sodium citrate on olfactory thresholds

Not Applicable

Completed

• Conditions: Ear, Nose and Throat: Smell ability; Ear, Nose and Throat; Smell ability

• Registration Number: ISRCTN50895907
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All patients with an objective reduction in their ability to smell.

Exclusion Criteria

Current inclusion criteria as of 19/02/2013:
1. Patients who are proven to have a normal sense of smell
2. Patients with nasal polyps or other sinonasal disease

Previous inclusion criteria until 19/02/2013:
1. Patients who are proven to have a normal sense of smell
2. Patients with nasal polyps

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure as 29/07/2016:<br>Olfactory threshold for PEA odour is measured using a psychophysical test (two-alternative forced choice ascending ladder technique) at baseline and 15 minute intervals up to 2 hours maximum.<br><br>Original primary outcome measure:<br>An improvement in their sense of smell and their general well-being.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measure as of 29/07/2016:<br>Olfactory thresholds for ACA, EUC and BUT odours are measured using a psychophysical test (two-alternative forced choice ascending ladder technique) at baseline and 15 minute intervals up to 2 hours maximum.<br><br>Secondary outcome measures added as of 19/02/2013:<br>A subjective improvement in their sense of smell and their general well-being