The Effect of Apple Fruit Extract (Malus Sylvestris Mill) as an Antioxidant and Anti-Inflammatory on Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total Nasal Symptom Score (TNSS)
研究概览
简要总结
This study was conducted to see before and after treatment whether it provided improvement in the patient's clinical symptoms.
详细描述
This research is the first to be conducted with preliminary research on humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Department Biomedic and Science Universitas Sebelas Maret Surakarta Indonesia, Department Pharmacy Universitas Muhammadiyah Surakarta Indonesia, Universitas Sebelas Maret Hospital Sukoharjo Indonesia
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Control Group
Loratadine 10 mg/day and Fluticasone Furoate 27.5 mcg twice daily.
干预措施: Loratadine 10 Mg (Other)
Control Group
Loratadine 10 mg/day and Fluticasone Furoate 27.5 mcg twice daily.
干预措施: Fluticasone Furoate (Other)
Treatment A: Quercetin 100 mg
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 100 mg/day.
干预措施: Quercetin (Other)
Treatment A: Quercetin 100 mg
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 100 mg/day.
干预措施: 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.
干预措施: Fluticasone Furoate (Other)
High-Dose Quercetin
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 200 mg/day.
干预措施: Quercetin (Other)
High-Dose Quercetin
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 200 mg/day.
干预措施: Loratadine 10 Mg (Other)
High-Dose Quercetin
Loratadine 10 mg/day, Fluticasone Furoate 27.5 mcg twice daily, and Quercetin 200 mg/day.
干预措施: Fluticasone Furoate (Other)
Apple Extract Only
Apple fruit extract (Malus sylvestris Mill) and Quercetin 200 mg/day.
干预措施: Quercetin (Other)
Apple Extract Only
Apple fruit extract (Malus sylvestris Mill) and Quercetin 200 mg/day.
干预措施: Apple Extract (Other)
结局指标
主要结局
Total Nasal Symptom Score (TNSS)
时间窗: 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.
次要结局
- 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)
研究者
Niken Dyah Aryani Kuncorowati
Otolaryngologist (ENT Specialist)
Universitas Sebelas Maret