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

• Sponsor: Gadjah Mada University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05960526
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.2
• Patients Per Site Per Month: 11.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis; Allergic Rhinitis Due to House Dust Mite	Drug: extract Binahong; Drug: Isotonic saline nasal irrigation	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy Of Nasal Irrigation With Combination of 0.9% NaCl and Binahong Extract (Anredera Cordifolia) 2,5% In Allergic Rhinitis
• Actual Study Start Date: May 6, 2023
• Anticipated Primary Completion Date: Sep 6, 2023
• Anticipated Study Completion Date: Dec 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Isotonic saline nasal irrigation; NaCl 0.9% as nasal irrigation solution; Other Names: Saline solution
Experimental: 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.	Drug: extract Binahong; Extract Binahong 2.5% as nasal irrigation solution; Other Names: extract Anredera cordifolia

Outcome Measures

Primary Outcome Measures

1. mRNA expression (IL-4, Il-6, IL-13, and TNF-α) [Change from baseline mRNA at two weeks.]

   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.

Secondary Outcome Measures

1. Clinical symptoms [Change from score baseline of clinical symptom at two weeks]

   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.

2. Physiology [Change from score baseline of physiology at two weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RS PKU Muhammadiyah	Yogyakarta	DIY	Indonesia	55294

Sponsors and Collaborators

• Gadjah Mada University

Investigators

• Principal Investigator: Bambang Rianto, MD OHNS, Gadjah Mada University

Study Documents (Full-Text)

• Study Protocol and Informed Consent Form - Mar 13, 2023

More Information

Publications

None provided.

• Responsible Party: Asti Widuri, Associate Professor, Gadjah Mada University
• ClinicalTrials.gov Identifier: NCT05960526
• Other Study ID Numbers: KE/FK/0419/EC/2023
• First Posted: Jul 25, 2023
• Last Update Posted: Jul 25, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Asti Widuri, Associate Professor, Gadjah Mada University: nasal irrigation; herbal medicine
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic

Study Results

No Results Posted as of Jul 25, 2023