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

NCT ID: NCT05960526

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-06
• Study Completion Date: 2024-12-10

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.

Conditions

Allergic Rhinitis; Allergic Rhinitis Due to House Dust Mite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

nasal irrigation with Saline group

The patient uses nasal irrigation with saline only and then mixed with 300 ml of water. The treatment was done by tilting the head 45 degrees, then spraying 150 ml of liquid on one side and repeating it on the other. The treatment was done twice daily (morning and evening) for 14 days.

Group Type: ACTIVE_COMPARATOR

Isotonic saline nasal irrigation

Intervention Type: DRUG

NaCl 0.9% as nasal irrigation solution

nasal irrigation with Saline combination with binahong extract

The patient uses nasal irrigation with saline and combination with Binahong Extract 2,5% and then mixed with 300 ml of water. The treatment was done by tilting the head 45 degrees, then spraying 150 ml of liquid on one side and repeating it on the other. The treatment was done twice daily (morning and evening) for 14 days.

Group Type: EXPERIMENTAL

extract Binahong

Intervention Type: DRUG

Extract Binahong 2.5% as nasal irrigation solution

Interventions

extract Binahong

Extract Binahong 2.5% as nasal irrigation solution

Intervention Type: DRUG

Isotonic saline nasal irrigation

NaCl 0.9% as nasal irrigation solution

Intervention Type: DRUG

Other Intervention Names

extract Anredera cordifolia; Saline solution

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gadjah Mada University

OTHER

Sponsor Role: lead

Responsible Party

Asti Widuri

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bambang Rianto, MD OHNS

Role: PRINCIPAL_INVESTIGATOR

Gadjah Mada University

Locations

RS PKU Muhammadiyah

Yogyakarta, DIY, Indonesia

Countries

Indonesia

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

KE/FK/0419/EC/2023

Identifier Type: -

Identifier Source: org_study_id