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

Primary Purpose

Allergic Rhinitis, Allergic Rhinitis Due to House Dust Mite

Status
Enrolling by invitation
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
extract Binahong
Isotonic saline nasal irrigation
Sponsored by
Gadjah Mada University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring nasal irrigation, herbal medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with allergic rhinitis symptoms (SFAR score ≥7) aged 18 to 65 years, male or female SPT examination results are positive Agree to participate in the study by filling out written informed consent Exclusion Criteria Pregnant or breastfeeding women Active smoker Local allergic rhinitis Patients with autoimmune diseases Chronic rhinosinusitis with or without nasal polyps

Sites / Locations

  • RS PKU Muhammadiyah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

nasal irrigation with Saline group

nasal irrigation with Saline combination with binahong extract

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

mRNA expression (IL-4, Il-6, IL-13, and TNF-α)
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

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.
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.

Full Information

First Posted
June 22, 2023
Last Updated
July 14, 2023
Sponsor
Gadjah Mada University
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1. Study Identification

Unique Protocol Identification Number
NCT05960526
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 6, 2023 (Actual)
Primary Completion Date
September 6, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gadjah Mada University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergic Rhinitis Due to House Dust Mite
Keywords
nasal irrigation, herbal medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nasal irrigation with Saline group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
nasal irrigation with Saline combination with binahong extract
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
extract Binahong
Other Intervention Name(s)
extract Anredera cordifolia
Intervention Description
Extract Binahong 2.5% as nasal irrigation solution
Intervention Type
Drug
Intervention Name(s)
Isotonic saline nasal irrigation
Other Intervention Name(s)
Saline solution
Intervention Description
NaCl 0.9% as nasal irrigation solution
Primary Outcome Measure Information:
Title
mRNA expression (IL-4, Il-6, IL-13, and TNF-α)
Description
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.
Time Frame
Change from baseline mRNA at two weeks.
Secondary Outcome Measure Information:
Title
Clinical symptoms
Description
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.
Time Frame
Change from score baseline of clinical symptom at two weeks
Title
Physiology
Description
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.
Time Frame
Change from score baseline of physiology at two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with allergic rhinitis symptoms (SFAR score ≥7) aged 18 to 65 years, male or female SPT examination results are positive Agree to participate in the study by filling out written informed consent Exclusion Criteria Pregnant or breastfeeding women Active smoker Local allergic rhinitis Patients with autoimmune diseases Chronic rhinosinusitis with or without nasal polyps
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bambang Rianto, MD OHNS
Organizational Affiliation
Gadjah Mada University
Official's Role
Principal Investigator
Facility Information:
Facility Name
RS PKU Muhammadiyah
City
Yogyakarta
State/Province
DIY
ZIP/Postal Code
55294
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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