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

January 26, 2026 updated by: Niken Dyah Aryani Kuncorowati, Universitas Sebelas Maret
This study was conducted to see before and after treatment whether it provided improvement in the patient's clinical symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Surakarta, Central Java, Indonesia, 57126
        • Universitas Sebelas Maret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Group
Loratadine 10 mg/day and Fluticasone Furoate 27.5 mcg twice daily.
Other: Loratadine 10 Mg
Control Loratadine 10 mg/day
Other: Fluticasone Furoate
Control Fluticasone Furoate 27.5 mcg twice daily
Experimental: Treatment A: Quercetin 100 mg
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 100 mg/day.
Other: Loratadine 10 Mg
Control Loratadine 10 mg/day
Other: Fluticasone Furoate
Control Fluticasone Furoate 27.5 mcg twice daily
Other: Quercetin
In the treatment group, standard therapy is given along with additional quercetin at different doses.
Experimental: High-Dose Quercetin
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 200 mg/day.
Other: Loratadine 10 Mg
Control Loratadine 10 mg/day
Other: Fluticasone Furoate
Control Fluticasone Furoate 27.5 mcg twice daily
Other: Quercetin
In the treatment group, standard therapy is given along with additional quercetin at different doses.
Experimental: Apple Extract Only
Apple fruit extract (Malus sylvestris Mill) and Quercetin 200 mg/day.
Other: Quercetin
In the treatment group, standard therapy is given along with additional quercetin at different doses.
Other: Apple Extract
In the treatment group is give of Apple extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 3, and Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, Month 3, and Month 6
Malondialdehyde (MDA) Levels
Time Frame: Baseline, Month 3, and Month 6
Oxidative stress marker measured using ELISA kit.
Baseline, Month 3, and Month 6
Nuclear Factor-Kappa Beta (NF-kB) Expression
Time Frame: Baseline, Month 3, and Month 6
Transcription factor expression by ELISA assay.
Baseline, Month 3, and Month 6
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).
Baseline, Month 3, and Month 6
Serum TNF-alpha Levels
Time Frame: Baseline, Month 3, and Month 6
Concentration of TNF-alpha measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Baseline, Month 3, and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sebelas Maret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

July 5, 2025

Study Registration Dates

First Submitted

July 20, 2025

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 007/12/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This research is related to the results of the dissertation as a requirement for graduating from a doctoral degree

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: Niken Dyah Aryani K,MD,ORL-HNS
    Information comments: Thank you and I hope this research can be used as a basis for additional therapy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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