Nasal Irrigation With Combination of 0.9% NaCl and Binahong Extract (Anredera Cordifolia) 2,5% In Allergic Rhinitis

Last updated: February 26, 2024
Sponsor: Gadjah Mada University
Overall Status: Active - Enrolling

Phase

1

Condition

Allergy (Pediatric)

Common Cold

Acute Rhinitis

Treatment

Isotonic saline nasal irrigation

extract Binahong

Clinical Study ID

NCT05960526
KE/FK/0419/EC/2023
  • Ages 18-65
  • All Genders

Study Summary

This randomized control trial study aims to know the effects of adding 2,5% Binahong extract on the effectiveness of NaCl 0.9% nasal irrigation in patients with allergic rhinitis. The main questions it aims to answer are:

  1. How does the efficacy of Binahong Extract 2,5% with 0,9% NaCl to mRNA expression (IL-4, Il-6, IL-13, and TNF-α)?

  2. How does the efficacy of Binahong Extract 2,5% with 0,9% NaCl to clinical symptoms?

  3. How does the efficacy of Binahong Extract 2,5% with 0,9% NaCl to quality of life?

  4. How does the efficacy of Binahong Extract 2,5% with 0,9% NaCl to physiology? Participants will use nasal irrigation two times daily for two weeks. Researchers will compare the nasal irrigation group using a combination of Binahong Extract 2,5% with the group using NaCl only to see the superior effect.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with allergic rhinitis symptoms (SFAR score ≥7) aged 18 to 65 years, male or female

  2. SPT examination results are positive

  3. Agree to participate in the study by filling out written informed consent

Exclusion Criteria

  1. Pregnant or breastfeeding women

  2. Active smoker

  3. Local allergic rhinitis

  4. Patients with autoimmune diseases

  5. Chronic rhinosinusitis with or without nasal polyps

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Isotonic saline nasal irrigation
Phase: 1
Study Start date:
May 06, 2023
Estimated Completion Date:
December 10, 2024

Study Description

Background: Nasal irrigation with NaCl 0.9% is a recommended adjuvant therapy for sinonasal diseases, including allergic rhinitis, to reduce symptoms and the use of drugs. The nasal irrigation mechanism physically cleans irritant particles adhering to the nasal mucosa, reduce inflammation by reducing the concentration of inflammatory mediators, improve mucociliary function by increasing nasal cavity fluid, humidity and repairs the mucosal epithelium. Binahong is a medicinal plant widely used to improve mucosal conditions, accelerate wound healing, and have an anti-inflammatory effect. With the addition of 2.5% Binahong extract in NaCl 0.9% solution, anti-inflammatory substances are expected to increase the effectiveness of nasal irrigation in patients with allergic rhinitis.

Objective: To know the effects of the addition 2.5% Binahong extract on the effectiveness of NaCl 0.9% nasal irrigation in patients with allergic rhinitis with the assessment of mRNA expression (IL-4, Il-6, IL-13, and TNF-α), clinical symptoms, quality of life, physiology, also to know the effectiveness analysis of intervention and side effects.

Methods: Analytical study designed in randomized control trials parallel groups, single-blind on adults subjects with allergic rhinitis. The diagnosis of AR was based on clinical symptoms of a Score for Allergic Rhinitis ≥7, supportive physical examination, and positive skin prick test result. Participants were randomly divided into two groups who were given NaCl 0.9 % nasal wash and NaCl 0.9 % nasal wash with 2.5% Binahong extract twice a day for 2 weeks. Examination of mRNA expression (IL-4, Il-6, IL-13, and TNF-α), clinical symptoms (SNOT-22), quality of life (Mini-RQLQ), physiology (nasal flow and patency, mucociliary transport time) were performed before and after treatment. The data were described, tested for normality and homogeneity, then analyzed by t-test and if significant, continued by N-Gain score analysis.

Outcome: Scientific evidence of results for the addition of 2.5% Binahong extract to NaCl 0.9% nasal irrigation on mRNA expression (IL-4, Il-6, IL-13, and TNF-α), clinical symptoms, quality of life, and physiology.

Connect with a study center

  • RS PKU Muhammadiyah

    Yogyakarta, DIY 55294
    Indonesia

    Site Not Available

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