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Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients

NCT04213508 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-01-22

No results posted yet for this study

Summary

Rhinosinusitis is a common clinical problem with significant morbidity which alters patients' quality of life that has its effect on 1 out of 7 adults. It has been found that rhinosinusitis accounts for almost 26 million clinics and emergency visits per year in United states .Nasal irrigation is standard management used to treat a variety of sinonasal diseases. Furthermore, nasal irrigation decreases the need of usage other medications in rhinosinusitis .Hence, it is considered safe, inexpensive, and easy to use with no evidence of major adverse effects .Up to our knowledge, there is no clear guideline in which type (isotonic saline vs hypertonic saline) and frequency (times per day) of nasal irrigation are superior and better.

Conditions

  • Otorhinolaryngologic Diseases
  • Rhinosinusitis

Interventions

DRUG

Isotonic Saline ( 0.9% Sodium Chloride Saline)

0.9% Sodium Chloride (NaCl) saline will be used as nasal irrigation for two groups. (first groups 2 times per day and second group 5 times per day ). Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 500 ml of 0.9% Sodium Chloride (NaCl) saline will be used daily for 1 month .

DRUG

Hypertonic Saline ( 3% Sodium Chloride Saline)

3% Sodium Chloride (NaCl) saline will be used as nasal irrigation for two groups. (first groups 2 times per day and second group 5 times per day ). Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time). So, in total 200 ml of 3% Sodium Chloride (NaCl) saline will be used daily for 1 month .

Sponsors & Collaborators

  • Imam Abdulrahman Bin Faisal University

    lead OTHER

Principal Investigators

  • Mohammad H Albar, MD · Imam Abdulrahman Bin Faisal University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-01-01
Completion
2021-12-31

Countries

  • Saudi Arabia

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 NCT04213508 on ClinicalTrials.gov