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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05960526
• Other study ID #: KE/FK/0419/EC/2023
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: May 6, 2023
• Est. completion date: December 10, 2024

Study information

• Verified date: February 2024
• Source: Gadjah Mada University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 10, 2024
• Est. primary completion date: September 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergic Rhinitis Due to House Dust Mite
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• extract Binahong
Extract Binahong 2.5% as nasal irrigation solution
• Isotonic saline nasal irrigation
NaCl 0.9% as nasal irrigation solution

Locations

Country	Name	City	State
Indonesia	RS PKU Muhammadiyah	Yogyakarta	DIY

Sponsors (1)

Lead Sponsor	Collaborator
Gadjah Mada University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mRNA expression (IL-4, Il-6, IL-13, and TNF-a)	RNA samples were obtained from the epithelial mucosa of the nasal mucosa using a cytology brush by inserting the brush and rubbing it on the superior and medial inferior concha mucosa 2-3 times in a circular and parallel motion on both the right and left nasal cavities.	Change from baseline mRNA at two weeks.
Secondary	Clinical symptoms	Clinical symptoms were measured using the SNOT questionnaire with 22 questions consisting of 6 choices; no problem, a very mild problem, a mild/slight problem, a moderate problem, a severe problem, a very severe problem using likert scale. Thus the minimum value of this questionnaire is 0, and the maximum is 110. The outcome data scale will be analyzed in numerical form.	Change from score baseline of clinical symptom at two weeks
Secondary	Physiology	Physiology is measured by calculating the time required for nasal mucociliary transport to move particles to the nasopharynx, carried out by the saccharin test, which calculates the time from when saccharin is placed in the anterior third of the inferior meatus nasal until it tastes sweet. The result will be analyzed in numerical form.	Change from score baseline of physiology at two weeks