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The Effect of Apple Fruit Extract (Malus Sylvestris Mill) as an Antioxidant and Anti-Inflammatory on Allergic Rhinitis

The Effect of Apple Fruit Extract (Malus Sylvestris Mill) as an Antioxidant and Anti-Inflammatory on Allergic Rhinitis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07380178
Enrollment
40
Registered
2026-02-02
Start date
2025-04-01
Completion date
2025-07-05
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Perennial

Keywords

allergic rhinitis, quercetin, antioxidant, anti-inflammatory

Brief summary

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.

Interventions

OTHERQuercetin

In the treatment group, standard therapy is given along with additional quercetin at different doses.

OTHERApple Extract

In the treatment group is give of Apple extract

Control Loratadine 10 mg/day

OTHERFluticasone Furoate

Control Fluticasone Furoate 27.5 mcg twice daily

Sponsors

Universitas Sebelas Maret
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Masking description

Department Biomedic and Science Universitas Sebelas Maret Surakarta Indonesia, Department Pharmacy Universitas Muhammadiyah Surakarta Indonesia, Universitas Sebelas Maret Hospital Sukoharjo Indonesia

Intervention model description

4 group study

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Total Nasal Symptom Score (TNSS)Baseline, Month 3, and Month 6The 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.

Secondary

MeasureTime frameDescription
Serum Interleukin-6 (IL-6) LevelsBaseline, Month 3, and Month 6Concentration of IL-6 measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Malondialdehyde (MDA) LevelsBaseline, Month 3, and Month 6Oxidative stress marker measured using ELISA kit.
Nuclear Factor-Kappa Beta (NF-kB) ExpressionBaseline, Month 3, and Month 6Transcription factor expression by ELISA assay.
Serum Interleukin-8 (IL-8) LevelsBaseline, Month 3, and Month 6Concentration of IL-6 measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Serum TNF-alpha LevelsBaseline, Month 3, and Month 6Concentration of TNF-alpha measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026