The Effect of Apple Fruit Extract (Malus Sylvestris Mill) as an Antioxidant and Anti-Inflammatory on Allergic Rhinitis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universitas Sebelas Maret
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Total Nasal Symptom Score (TNSS)
Overview
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.
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Control Group
Loratadine 10 mg/day and Fluticasone Furoate 27.5 mcg twice daily.
Intervention: Loratadine 10 Mg (Other)
Control Group
Loratadine 10 mg/day and Fluticasone Furoate 27.5 mcg twice daily.
Intervention: Fluticasone Furoate (Other)
Treatment A: Quercetin 100 mg
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 100 mg/day.
Intervention: Quercetin (Other)
Treatment A: Quercetin 100 mg
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 100 mg/day.
Intervention: Loratadine 10 Mg (Other)
Treatment A: Quercetin 100 mg
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 100 mg/day.
Intervention: Fluticasone Furoate (Other)
High-Dose Quercetin
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 200 mg/day.
Intervention: Quercetin (Other)
High-Dose Quercetin
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 200 mg/day.
Intervention: Loratadine 10 Mg (Other)
High-Dose Quercetin
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 200 mg/day.
Intervention: Fluticasone Furoate (Other)
Apple Extract Only
Apple fruit extract (Malus sylvestris Mill) and Quercetin 200 mg/day.
Intervention: Quercetin (Other)
Apple Extract Only
Apple fruit extract (Malus sylvestris Mill) and Quercetin 200 mg/day.
Intervention: Apple Extract (Other)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Niken Dyah Aryani Kuncorowati
Otolaryngologist (ENT Specialist)
Universitas Sebelas Maret