Effectiveness of Manuka Honey/Saline Nasal Rinses as an Adjunct to Standard Medical Therapy for Chronic Rhinosinusitis: A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in SNOT-22 Symptomatic Scores at 6 months
研究概览
简要总结
The purpose of this study is to evaluate whether high-volume nasal rinses with a manuka honey/saline mixture will improve symptom scores, nasal endoscopic findings and CT scan findings compared to nasal saline rinse without manuka honey in patients with chronic rhinosinusitis.
Manuka honey is a honey made from bees that drink the nectar from tea (manuka) trees in New Zealand. It has been shown to have antibacterial activity against common bacteria that cause chronic sinusitis.
详细描述
If the subject chooses to participate in the study, the subject will be asked to fill out a symptom questionnaire at the beginning of the study and at each follow-up visit. The subject will be randomly assigned (much like the flip of a coin) to one of two treatment arms in addition to the prescribed medical treatments: 1) nasal rinses twice daily with a saline solution (standard therapy) or 2) nasal rinses with a saline solution mixed with manuka honey (the experimental therapy.) Subjects in the manuka honey/saline rinse arm will perform the experimental rinses twice daily for one month, and then will continue with saline rinses twice daily, with manuka honey added to the rinses only as needed. Nasal rinsing of some kind will be continued through the entire study period.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Rhinosinusitis
- •Nasal Polyposis stages 1-3
排除标准
- •Nasal Polyposis stage 4-5
- •Cystic Fibrosis
- •Immunocompromised patients
- •Allergy to bees or honey
研究组 & 干预措施
NeilMed Saline Sinus Rinse
Saline nasal rinses will be performed using a NeilMed® Sinus Rinse 240 ml bottle and one NeilMed® packet containing sodium chloride/sodium bicarbonate at a concentration to make an isotonic solution when mixed with distilled or previously boiled water.
干预措施: NeilMed Saline Sinus Rinse (Other)
Saline mixed with Manuka Honey
Saline mixed with MH nasal rinses participants will be instructed how to mix a rounded teaspoon of MH (Wedderspoon® 100% Raw Manuka Honey Active 16+) with 4-6 oz of lukewarm distilled or previously boiled water, to add along with distilled or previously boiled water and the NeilMed® Sinus Rinse packet to the rinse bottle to a final volume of 240 ml. Participants will be instructed to rinse slowly with the MH/saline rinse mixture to maximize contact time with the MH/saline mixture.
干预措施: Saline mixed with Manuka Honey (Other)
结局指标
主要结局
Change in SNOT-22 Symptomatic Scores at 6 months
时间窗: Change from baseline at 6 months
There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.
Change in SNOT-22 Symptomatic Scores at 3 months
时间窗: Change from baseline at 3 months
There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.
Change in SNOT-22 Symptomatic Scores at 1 month
时间窗: Change from baseline at 1 month
There are 22 questions, each scored 0 - 5. Possible scores are 0 - 110. The best score is 0, the worst score is 110.
次要结局
- Change in Endoscopic Scores of CRS severity in the different treatment arms at 3 months(Change in baseline at 3 months)
- Change in Endoscopic Scores of CRS severity in the different treatment arms at 1 month(Change in baseline at 1 month)
- Change in Endoscopic Scores of CRS severity in the different treatment arms at 6 months(Change in baseline at 6 months)
- Change in Radiologic Scores of CRS severity in the different treatment arms at 3 months(Change in baseline at 3 months)