Allergic RhinitisPhase 1NCT05960526
Nasal Irrigation With Combination of 0.9% NaCl and Binahong Extract (Anredera Cordifolia) 2,5% In Allergic Rhinitis
A Phase 1 study testing extract Binahong and Isotonic saline nasal irrigation in people with Allergic Rhinitis and Allergic Rhinitis Due to House Dust Mite, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinitis Due to House Dust Mite
- What is being tested?
- extract Binahong and Isotonic saline nasal irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 6 May 2023to 10 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding women
- Active smoker
- Local allergic rhinitis
- Patients with autoimmune diseases
- Chronic rhinosinusitis with or without nasal polyps
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Of Nasal Irrigation With Combination of 0.9% NaCl and Binahong Extract (Anredera Cordifolia) 2,5% In Allergic Rhinitis
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.
Read the 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.
- Being tested
- extract Binahong, Isotonic saline nasal irrigation
- Keywords
- nasal irrigation, herbal medicine
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extract BinahongDrug
Also called extract Anredera cordifolia
Extract Binahong 2.5% as nasal irrigation solution
Isotonic saline nasal irrigationDrug
Also called Saline solution
NaCl 0.9% as nasal irrigation solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: extract Binahong |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline mRNA at two weeks.
Secondary outcomes (2)
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.
Measured: Change from score baseline of clinical symptom at two weeks
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.
Measured: Change from score baseline of physiology at two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start6 May 2023
- Primary completion6 Sep 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asti Widuri, Gadjah Mada University
- Investigators
- Bambang Rianto, MD OHNS, Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960526
- Sponsor's protocol ID
- KE/FK/0419/EC/2023
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Nasal Irrigation With Combination of 0.9% NaCl and Binahong Extract (Anredera Cordifolia) 2,5% In Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05960526
- Acronym / sponsor ID
- KE/FK/0419/EC/2023
- Keywords
- nasal irrigation, herbal medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 6 Sep 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal irrigation with Saline group | Active comparator | Drug: Isotonic saline nasal irrigationThe 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. |
| nasal irrigation with Saline combination with binahong extract | Experimental | Drug: extract BinahongThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- Active smoker
- Local allergic rhinitis
- Patients with autoimmune diseases
- Chronic rhinosinusitis with or without nasal polyps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extract BinahongAlso: extract Anredera cordifoliaExtract Binahong 2.5% as nasal irrigation solution | Drug | nasal irrigation with Saline combination with binahong extract |
| Isotonic saline nasal irrigationAlso: Saline solutionNaCl 0.9% as nasal irrigation solution | Drug | nasal irrigation with Saline group |
Primary outcome
mRNA expression (IL-4, Il-6, IL-13, and TNF-α)
Time frame: 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.
2 secondary outcomes
Clinical symptoms
Time frame: Change from score baseline of clinical symptom at two weeks
Physiology
Time frame: Change from score baseline of physiology at two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bambang Rianto, MD OHNS principal investigator
Gadjah Mada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing extract Binahong and Isotonic saline nasal irrigation in people with Allergic Rhinitis and Allergic Rhinitis Due to House Dust Mite, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA expression (IL-4, Il-6, IL-13, and TNF-α) (time frame: Change from baseline mRNA at two weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.