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
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