Efficacy and Safety in Self-Prepared Nasal Saline Irrigation and Clinical Outcome in Patient with Allergic Rhinitis

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20160120001
• Date of registration: 20/01/2016
• Prospective Registration: Yes
• Primary sponsor: Faculty of pharmacy , Mahasarakham university
• Public title: Efficacy and Safety in Self-Prepared Nasal Saline Irrigation and Clinical Outcome in Patient with Allergic Rhinitis
• Scientific title: Efficacy and Safety in Self-Prepared Nasal Saline Irrigation and Clinical Outcome in Patient with Allergic Rhinitis
• Date of first enrolment: 20/01/2016
• Target sample size: 264
• Recruitment status: Recruiting
• URL: https://www.thaiclinicaltrials.org/show/TCTR20160120001
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 2

Countries of recruitment

Thailand

Contacts

• Name: Krongkwan Duangpawang
• Affiliation: Faculty of pharmacy

• Name: Krongkwan Duangpawang
• Affiliation: Faculty of pharmacy

Key inclusion & exclusion criteria

Inclusion criteria: 1.Age 18-65 years,all gender.
2.Underlying disease is Allergic disease.
3.Have a running nose with these symtoms at least 1 symptom
3.1 sneezing
3.2 congestion
3.3 itching
3.4 conjunctivitis

Exclusion criteria: 1.Seafood allergy.
2.Have an abnormal in internal nostril.
3.Have a sign of infection (fever,body temperature>38 celcius or purulent in nostril or pain in nostril or get an antibiotic)
4.Tumor in nostril.
5.Abnormal structure of septum nose.
6.Abnormal mucocialiary




Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

1.Allergic rhinitis
1.Allergic rhinitis
2.Self prepared
3.Saline irrigation
4.Hypertonic saline
5.Isotonic saline

1.Allergic rhinitis
2.Self prepared
3.Saline irrigation
4.Hypertonic saline
5.Isotonic saline

Intervention(s)

normal saline ,Hypertonic saline ,Normal saline (klean & kare)

Experimental Other,Experimental Other,Active Comparator Other

Adjuvant therapy 0.9% NaCl irrigate 2 time per day, 80 ml per nostril ,Adjuvant therapy 1.8% NaCl irrigate 2 time per day, 80 ml per nostril ,Adjuvant therapy 0.9% NaCl irrigate 2 time per day, 80 ml per nostril

Primary Outcome(s)

Quality of life At 1 months after end of intervention Rcq-36

Secondary Outcome(s)

Total nasal symptom score At 1 months after end of intervention TNSS

Source(s) of Monetary Support

Faculty of pharmacy , Mahasarakham university

Secondary Sponsor(s)

Faculty of pharmacy , Mahasarakham university

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Ethics studies in humans (faculty of pharmacy)

Results

• Date Completed: 30/04/2016