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Hypertonic Saline Nasal Irrigation and Gargling for the Common Cold.

NCT02438579 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2015-12-15

No results posted yet for this study

Summary

Viral upper respiratory tract infections (URTI), one of the commonest infection faced by humans, have a significant impact on individuals, families, health service and economy. Though rhinoviruses are called the "common cold virus", numerous viruses can cause URTI. Hence virus specific remedy for URTI is impractical. There are currently no evidence-based interventions that reduce the severity, symptom duration or viral shedding. Preliminary evidence suggests that hypertonic saline nasal irrigation and gargling (HSNIG) may reduce the duration of symptoms.

With this pilot randomised controlled trial (RCT), the investigators aim to assess the feasibility of undertaking a definitive RCT of HSNIG in adults with URTI. This pilot focuses on recruitment rate, willingness to be randomised, acceptability, compliance and likely effect size of the intervention.

This pilot RCT compares HSNIG vs. usual care in 60 adults. Serial self-collected mid-turbinate swabs will help assess change in viral shedding. Symptomatic relief is measured by a validated symptom score. A questionnaire based participant feedback will help assess intervention and trial procedures.

This mixed-methods pilot trial will help inform plans for a definitive RCT of this low-cost intervention that has the potential of substantial health and societal benefits.

Conditions

  • Common Cold
  • Upper Respiratory Tract Infections

Interventions

OTHER

Nasal Irrigation & Gargling

Participants are advised to perform the intervention as frequently as required (expected frequency around 6 times a day for the first two days, reducing in frequency from day 3 as symptoms improve).

Sponsors & Collaborators

  • University of Edinburgh

    collaborator OTHER

  • NHS Lothian

    lead OTHER_GOV

Principal Investigators

  • Sandeep Ramalingam, PhD, FRCPath · NHS Lothian

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-04-30
Completion
2015-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02438579 on ClinicalTrials.gov