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临床试验/NCT06715800
NCT06715800已完成不适用

Symptomatic Relief of Sore Throat With Functional Honey: A Randomized Controlled Trial

Medipol University2 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2022年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
282
试验地点
2
主要终点
Clinical Symptome

研究概览

简要总结

Objective: The aim of this study is to investigate the symptomatic efficacy of oral use of different functional honeys in patients complaining of sore throat.

Materials and Methods: In the preclinical phase of the study, a total of 1000 samples of honey were examined, and the honeys were subjected to physicochemical and microbiological analyses. Based on their functional properties, five different groups of honey were determined. These are thyme honey with high antioxidant capacity, Yüksekova with high antimicrobial activity, chestnut honey with high organic acid amount, linden honey with high enzymatic and pine honey with high anti-microbial, antioxidant and phenolic compounds and enzymes. In the clinical phase of the study, patients receiving conventional treatment were randomly assigned to receive either one of five different types of honey or a honey-like food product in addition to their treatment. They were instructed to use 15 grams twice daily for 10 days. Patients were assessed on the 1st, 3rd, 7th, and 10th days for symptoms and complaints such as sore throat, difficulty swallowing, sensation of throat swelling, weakness, and fatigue.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults presenting with sore throat symptoms due to an upper respiratory infection (URI) within the last four days were included in the study. A total of 300 patients over 18 years of age, who were prescribed necessary medication and exhibited signs and symptoms of sore throat, were enrolled.

排除标准

  • Exclusion criteria included a history of diabetes, pollen or bee allergies, and aversion to honey. Participants were required not to use any additional products outside of those provided by the researchers during the study period. Written informed consent was obtained from all participants, who were then randomly assigned to either the study or control group.

结局指标

主要结局

Clinical Symptome

时间窗: 10 days

Symptom Evaluation: On days 3, 7, and 10, patients were assessed for throat pain, difficulty swallowing, throat swelling, and fatigue/malaise. Throat Pain: Assessed using a Numeric Rating Scale (NRS) (0: no pain, 10: very painful). Difficulty Swallowing: Assessed using a NRS (0: no difficulty, 10: very difficult). Throat Swelling Sensation: Assessed using a NRS (0: no swelling, 10: severe swelling sensation). Fatigue/Malaise: Assessed using a NRS (0: no fatigue, 10: severe fatigue).

次要结局

未报告次要终点

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Timucin ATAYOGLU

Assoc. Prof.

Medipol University

研究点 (2)

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