Clinical trial NCT05960526: Nasal Irrigation With Combination of 0.9% NaCl and Binahong Extract (Anredera Cordifolia) 2,5% In Allergic Rhinitis
Official title: Efficacy Of Nasal Irrigation With Combination of 0.9% NaCl and Binahong Extract (Anredera Cordifolia) 2,5% In Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Allergic Rhinitis
Allergic Rhinitis Due to House Dust Mite
Keywords: nasal irrigation
herbal medicine
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: mRNA expression (IL-4, Il-6, IL-13, and TNF-α)
timeFrame: Change from baseline mRNA at two weeks.
Secondary outcomes:
measure: Clinical symptoms
timeFrame: Change from score baseline of clinical symptom at two weeks
measure: Physiology
timeFrame: Change from score baseline of physiology at two weeks
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: RS PKU Muhammadiyah
state: DIY
Study officials:
affiliation: Gadjah Mada University
name: Bambang Rianto, MD OHNS
role: PRINCIPAL_INVESTIGATOR
References: