Efficacy of Berry Leaves & Mango Leaves Mixture in Symptomatic Treatments on Disease-related Quality of Life in Adults With Clinically Diagnosed Acute Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Reduction of SNOT 16 score after treatment
研究概览
简要总结
The objective of this phase I controlled clinical trial is to determine the safety and efficacy of Berry leaves & Mango leaves mixture in symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute rhinosinusitis. Ten adult subjects, 18 to 70 years old, who meet the recommended criteria for acute rhinosinusitis, will be enrolled from Minia university ENT outpatient Clinic. Subjects will be advised to add Berry leaves & Mango leaves herbal tea mixture and followed for one month with their routine therapy (an oral decongestant, a nasal saline spray, and an antitussive agent except analgesic). Subject outcomes will be assessed by telephone interview at 0, 3, 7, 10, and 28 days. The Quality-of-life outcomes are measured on Day 3, 10 and 28 with SNOT-16, a validated evaluative instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must have symptoms of acute bacterial rhinosinusitis.
- •The subject should be able to be self-assessed as moderate, severe, or very severe.
- •The subject must have access to a phone.
- •The subject must accept sharing and sign consent.
- •The subject should follow instructions carefully and not miss times of assessment
排除标准
- •The subject has an allergy to: Flavonoids, phenolic acids, anthocyanins, carotenoids.
- •The subject has complications of sinusitis (facial edema, cellulitis, or orbital, meningeal or cerebral signs).
- •The subject is pregnancy.
- •The subject has a comorbidity that may impair their immune response (such as immunodeficiency disease, uncontrolled cancer, or chemotherapy or radiation treatment).
- •The subject has cystic fibrosis
研究组 & 干预措施
Routine therapy
Steroid plus oral antibiotics in their normal doses
干预措施: local steroids (Drug)
Routine therapy
Steroid plus oral antibiotics in their normal doses
干预措施: amoxicillin clavulanates (Drug)
Nasal irrigation Plus antibiotic
Nasal irrigation daily Plus oral antibiotics
干预措施: amoxicillin clavulanates (Drug)
Nasal irrigation Plus antibiotic
Nasal irrigation daily Plus oral antibiotics
干预措施: nasal saline (Other)
herbal tea group
Herbal tea 3 mgs three times a day plus oral antibiotic
干预措施: mango leaves extract (Dietary Supplement)
herbal tea group
Herbal tea 3 mgs three times a day plus oral antibiotic
干预措施: amoxicillin clavulanates (Drug)
结局指标
主要结局
Reduction of SNOT 16 score after treatment
时间窗: 14 days
次要结局
未报告次要终点
研究者
Soad Ali
associate professor
Deraya University