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Completed

NCT Number: NCT07380178

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

This study was conducted to see before and after treatment whether it provided improvement in the patient's clinical symptoms.

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Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Sebelas Maret Hospital

Surakarta, Central Java, 57126, Indonesia

About this study

This research is the first to be conducted with preliminary research on humans.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quercetin

Other

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

Apple Extract

Other

In the treatment group is give of Apple extract

Loratadine 10 Mg

Other

Control Loratadine 10 mg/day

Fluticasone Furoate

Other

Control Fluticasone Furoate 27.5 mcg twice daily

Primary outcomes

  1. 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.

Secondary outcomes

  1. Serum Interleukin-6 (IL-6) Levels

    Time frame: Baseline, Month 3, and Month 6

    Concentration of IL-6 measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  2. Malondialdehyde (MDA) Levels

    Time frame: Baseline, Month 3, and Month 6

    Oxidative stress marker measured using ELISA kit.

  3. Nuclear Factor-Kappa Beta (NF-kB) Expression

    Time frame: Baseline, Month 3, and Month 6

    Transcription factor expression by ELISA assay.

  4. Serum Interleukin-8 (IL-8) Levels

    Time frame: Baseline, Month 3, and Month 6

    Concentration of IL-6 measured using Enzyme-Linked Immunosorbent Assay (ELISA).

  5. Serum TNF-alpha Levels

    Time frame: Baseline, Month 3, and Month 6

    Concentration of TNF-alpha measured using Enzyme-Linked Immunosorbent Assay (ELISA).

Sponsors and collaborators

Lead sponsor

Universitas Sebelas Maret

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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