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

NCT07380178 | Completed DMC

• 1 other identifier: 007/12/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rhinitis, Allergic, Perennial

Keywords

allergic rhinitis; quercetin; antioxidant; anti-inflammatory

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Month 3, and Month 6

Secondary Outcomes (5)

• Serum Interleukin-6 (IL-6) Levels

  Baseline, Month 3, and Month 6

• Malondialdehyde (MDA) Levels

  Baseline, Month 3, and Month 6

• Nuclear Factor-Kappa Beta (NF-kB) Expression

  Baseline, Month 3, and Month 6

• Serum Interleukin-8 (IL-8) Levels

  Baseline, Month 3, and Month 6

• Serum TNF-alpha Levels

  Baseline, Month 3, and Month 6

Study Arms (4)

Control Group

EXPERIMENTAL

Loratadine 10 mg/day and Fluticasone Furoate 27.5 mcg twice daily.

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.

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.

Other: Quercetin; Other: Loratadine 10 Mg; Other: Fluticasone Furoate

Apple Extract Only

EXPERIMENTAL

Apple fruit extract (Malus sylvestris Mill) and Quercetin 200 mg/day.

Other: Quercetin; Other: Apple Extract

Interventions

Quercetin OTHER

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

Apple Extract Only; High-Dose Quercetin; Treatment A: Quercetin 100 mg

Apple Extract OTHER

In the treatment group is give of Apple extract

Apple Extract Only

Loratadine 10 Mg OTHER

Control Loratadine 10 mg/day

Control Group; High-Dose Quercetin; Treatment A: Quercetin 100 mg

Fluticasone Furoate OTHER

Control Fluticasone Furoate 27.5 mcg twice daily

Control Group; High-Dose Quercetin; Treatment A: Quercetin 100 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: age 18 - 60 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

Universitas Sebelas Maret Hospital

Surakarta, Central Java, 57126, Indonesia

Location

Related Links

• protocol research

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic

Interventions

Quercetin; apple polyphenol extract; Loratadine; fluticasone furoate

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Department Biomedic and Science Universitas Sebelas Maret Surakarta Indonesia, Department Pharmacy Universitas Muhammadiyah Surakarta Indonesia, Universitas Sebelas Maret Hospital Sukoharjo Indonesia
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otolaryngologist (ENT Specialist)

Model Details: 4 group study

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: February 2, 2026
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 5, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)