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

NCT05960526 | Enrolling By Invitation Phase 1

• 1 other identifier: KE/FK/0419/EC/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 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. 2.How does the efficacy of Binahong Extract 2,5% with 0,9% NaCl to clinical symptoms?
3. 3.How does the efficacy of Binahong Extract 2,5% with 0,9% NaCl to quality of life?
4. 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.

Conditions

Allergic Rhinitis; Allergic Rhinitis Due to House Dust Mite

Keywords

nasal irrigation; herbal medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline mRNA at two weeks.

Secondary Outcomes (2)

• Clinical symptoms

  Change from score baseline of clinical symptom at two weeks

• Physiology

  Change from score baseline of physiology at two weeks

Study Arms (2)

nasal irrigation with Saline group

ACTIVE COMPARATOR

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

nasal irrigation with Saline combination with binahong extract

EXPERIMENTAL

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

Interventions

extract Binahong DRUG

Extract Binahong 2.5% as nasal irrigation solution

Also known as: extract Anredera cordifolia

nasal irrigation with Saline combination with binahong extract

Isotonic saline nasal irrigation DRUG

NaCl 0.9% as nasal irrigation solution

Also known as: Saline solution

nasal irrigation with Saline group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding women
• Active smoker
• Local allergic rhinitis
• Patients with autoimmune diseases
• Chronic rhinosinusitis with or without nasal polyps

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

RS PKU Muhammadiyah

Yogyakarta, DIY, 55294, Indonesia

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bambang Rianto, MD OHNS

  Gadjah Mada University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 25, 2023
• Study Start: May 6, 2023
• Primary Completion: September 6, 2024
• Study Completion: December 10, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)