Rhinitis, Allergic, PerennialNCT07380178
The Effect of Apple Fruit Extract (Malus Sylvestris Mill) as an Antioxidant and Anti-Inflammatory on Allergic Rhinitis
A study testing Quercetin, Apple Extract and Loratadine 10 Mg in people with Rhinitis, Allergic, Perennial, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
This study was conducted to see before and after treatment whether it provided improvement in the patient's clinical symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Quercetin, Apple Extract and Loratadine 10 Mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2025to 5 Jul 2025
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 - 60 years who have signed an informed consent
- Diagnosed with persistent allergic rhinitis with a Skin Prick Test or Positive IgE Examination.
Who cannot join
- The presence of complications in the nose such as nasal septum deviation, polyps, rhinosinusitis
- Have undergone specific immunotherapy for 2 years
- Use of drugs that affect allergy test results: antihistamines, corticosteroids, antihypertensive drugs, and decongestants
- Pregnancy and Breastfeeding
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Sebelas Maret Hospital
Surakarta, Central Java, 57126
About this study
This study was conducted to see before and after treatment whether it provided improvement in the patient's clinical symptoms.
Read the detailed description
This research is the first to be conducted with preliminary research on humans.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Quercetin, Apple Extract, Loratadine 10 Mg, Fluticasone Furoate
- Keywords
- allergic rhinitis, quercetin, antioxidant, anti-inflammatory
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinOther
In the treatment group, standard therapy is given along with additional quercetin at different doses.
Apple ExtractOther
In the treatment group is give of Apple extract
Loratadine 10 MgOther
Control Loratadine 10 mg/day
Fluticasone FuroateOther
Control Fluticasone Furoate 27.5 mcg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Loratadine 10 mg/day and Fluticasone Furoate 27.5 mcg twice daily. Receives: Other: Loratadine 10 Mg; Other: Fluticasone Furoate |
| Treatment A: Quercetin 100 mg | Experimental | Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 100 mg/day. Receives: Other: Quercetin; Other: Loratadine 10 Mg; Other: Fluticasone Furoate |
| High-Dose Quercetin | Experimental | Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 200 mg/day. Receives: Other: Quercetin; Other: Loratadine 10 Mg; Other: Fluticasone Furoate |
| Apple Extract Only | Experimental | Apple fruit extract (Malus sylvestris Mill) and Quercetin 200 mg/day. Receives: Other: Quercetin; Other: Apple Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
The TNSS evaluates the severity of four nasal symptoms: nasal congestion, sneezing, nasal itching, and rhinorrhea. Each symptom is rated on a 4-point scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The total score is the sum of the four individual symptom scores, ranging from 0 to 12. Higher scores indicate worse symptom severity.
Measured: Baseline, Month 3, and Month 6
Secondary outcomes (5)
Serum Interleukin-6 (IL-6) Levels
Concentration of IL-6 measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Baseline, Month 3, and Month 6
Malondialdehyde (MDA) Levels
Oxidative stress marker measured using ELISA kit.
Measured: Baseline, Month 3, and Month 6
Nuclear Factor-Kappa Beta (NF-kB) Expression
Transcription factor expression by ELISA assay.
Measured: Baseline, Month 3, and Month 6
Serum Interleukin-8 (IL-8) Levels
Concentration of IL-6 measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Baseline, Month 3, and Month 6
Serum TNF-alpha Levels
Concentration of TNF-alpha measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Baseline, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Apr 2025
- Primary completion1 Jul 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4 group study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niken Dyah Aryani Kuncorowati, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380178
- Sponsor's protocol ID
- 007/12/2024
- Status last verified
- Jan 2026
- First submitted
- 20 Jul 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This research is related to the results of the dissertation as a requirement for graduating from a doctoral degree
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Apple Fruit Extract (Malus Sylvestris Mill) as an Antioxidant and Anti-Inflammatory on Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT07380178
- Acronym / sponsor ID
- 007/12/2024
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- allergic rhinitis, quercetin, antioxidant, anti-inflammatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 2 Feb 2026 (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 study was conducted to see before and after treatment whether it provided improvement in the patient's clinical symptoms.
Detailed description
This research is the first to be conducted with preliminary research on humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4 group study
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Loratadine 10 Mg, Other: Fluticasone FuroateLoratadine 10 mg/day and Fluticasone Furoate 27.5 mcg twice daily. |
| Treatment A: Quercetin 100 mg | Experimental | Other: Quercetin, Other: Loratadine 10 Mg, Other: Fluticasone FuroateLoratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 100 mg/day. |
| High-Dose Quercetin | Experimental | Other: Quercetin, Other: Loratadine 10 Mg, Other: Fluticasone FuroateLoratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 200 mg/day. |
| Apple Extract Only | Experimental | Other: Quercetin, Other: Apple ExtractApple fruit extract (Malus sylvestris Mill) and Quercetin 200 mg/day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged 18 - 60 years who have signed an informed consent
- Diagnosed with persistent allergic rhinitis with a Skin Prick Test or Positive IgE Examination.
Key exclusion criteria (4 listed)
- The presence of complications in the nose such as nasal septum deviation, polyps, rhinosinusitis
- Have undergone specific immunotherapy for 2 years
- Use of drugs that affect allergy test results: antihistamines, corticosteroids, antihypertensive drugs, and decongestants
- Pregnancy and Breastfeeding
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 |
|---|---|---|
| QuercetinIn the treatment group, standard therapy is given along with additional quercetin at different doses. | Other | Apple Extract Only, High-Dose Quercetin, Treatment A: Quercetin 100 mg |
| Apple ExtractIn the treatment group is give of Apple extract | Other | Apple Extract Only |
| Loratadine 10 MgControl Loratadine 10 mg/day | Other | Control Group, High-Dose Quercetin, Treatment A: Quercetin 100 mg |
| Fluticasone FuroateControl Fluticasone Furoate 27.5 mcg twice daily | Other | Control Group, High-Dose Quercetin, Treatment A: Quercetin 100 mg |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: Baseline, Month 3, and Month 6
The TNSS evaluates the severity of four nasal symptoms: nasal congestion, sneezing, nasal itching, and rhinorrhea. Each symptom is rated on a 4-point scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The total score is the sum of the four individual symptom scores, ranging from 0 to 12. Higher scores indicate worse symptom severity.
5 secondary outcomes
Serum Interleukin-6 (IL-6) Levels
Time frame: Baseline, Month 3, and Month 6
Malondialdehyde (MDA) Levels
Time frame: Baseline, Month 3, and Month 6
Nuclear Factor-Kappa Beta (NF-kB) Expression
Time frame: Baseline, Month 3, and Month 6
Serum Interleukin-8 (IL-8) Levels
Time frame: Baseline, Month 3, and Month 6
Serum TNF-alpha Levels
Time frame: Baseline, Month 3, and Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- protocol researchLink provided by the sponsor.
- Individual participant dataSharing planned: No. This research is related to the results of the dissertation as a requirement for graduating from a doctoral degree
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quercetin, Apple Extract and Loratadine 10 Mg in people with Rhinitis, Allergic, Perennial, run by Universitas Sebelas Maret 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 2 Feb 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Nasal Symptom Score (TNSS) (time frame: Baseline, Month 3, and Month 6). 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 2 Feb 2026.