Propolis as a Treatment Option for Hand Foot and Mouth Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Propolis treatment
研究概览
简要总结
Hand foot and mouth disease (HFMD) is a frequently self-limited viral infectious disease in children with no specific antiviral treatment option. There has been an increasing interest in bee products in recent years, and propolis has come to the fore with its high therapeutic and protective effect. Although the inhibitory effect of propolis against enteroviruses (EVs) has been shown in studies, there is no clinical data regarding its use in the course of HFMD.
The aim of this prospective multicenter randomized clinical study was to evaluate the effect of propolis use in children with HFMD. The patients were randomly assigned to have Anatolian propolis or no supplement - control group in addition to symptomatic therapy decided by the physician. The duration of the patients' complaints, the distribution of the lesions in the body, and the fever status were recorded on admission. Parents were asked to rate the severity of the child's restlessness, inappetence, and sleeplessness status on a scale of 0-10 on the initial, 2nd (at 48th hour), and 3rd (on 5-7 days) visits.
详细描述
Title of the Research Project / Thesis: "Evaluation of the effectiveness of Propolis in children with hand, foot and mouth disease"
INTRODUCTION AND PURPOSE Hand, foot and mouth disease is a highly contagious viral disease, especially in children under 10 years of age. Rarely, the disease can also be seen in older children and adults. It is a clinical picture characterized by fever, sore throat, loss of appetite, weakness, and rashes in and around the mouth, palms and soles of the feet. Rashes can be in the form of red, round lesions, or sometimes they can be seen in the form of fluid-filled vesicles. Hand, foot and mouth disease is mostly a self-limiting viral disease that does not cause severe disease. Patients recover completely within 7 to 10 days with the disappearance of all developing findings. As a very rare complication, it can cause viral or aseptic meningitis.
The patients were planned to be divided into two groups by randomization, the propolis group and the placebo group. Fever, sore throat, loss of appetite, weakness, rash and other complaints of the patients will be recorded at the time of admission and treatment will be started according to the randomization group. The patient will be given a family follow-up form and will be asked to follow up the complaints. At the 48th and 72nd hours of the follow-up, the patient was scheduled to be called for the first follow-up in terms of complaints and undesirable effects. The second and final follow-up was planned to be done on the 10th day and the patient follow-up was terminated as a family follow-up card. The number of patients targeted to be reached was determined as 100 for each group. The study period is foreseen as a total of 12 months, including 6 months for the collection of samples and data, 6 months for statistical analysis, evaluation of the results and writing them as an article. Statistical evaluation of the findings will be made with a statistical package program.
DOSES; Propolis 3x5 drops
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
盲法说明
Patients in both groups were prescribed antipyretics and antihistamines when deemed appropriate by the clinician. Propolis 3x10 drops (7 days) were used in the propolis group. Both the investigators and the patients were aware of the drug being given.
A computerized randomization program was used for group selection.
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with HMFD
- •1-10 years old
排除标准
- •The patients whose complaints were longer than 48 hours,
- •those whose parents stated that they could not comply with the follow ups,
- •those who were taking another antiviral or supportive treatment,
- •those who had used antibiotics in the last 1 month,
- •those with a history of immunodeficiency or a family history of immunodeficiency,
- •those who had a history of anaphylaxis with any support product or drug,
- •patients with a chronic disease or skin lesion
研究组 & 干预措施
Propolis group
. Propolis 3x10 drops (7 days) were used in the propolis group.
干预措施: Propolis (Drug)
结局指标
主要结局
Propolis treatment
时间窗: 48 hours and 7 days
Parents were asked to rate the severity of the child's restlessness, inappetence, and sleeplessness status on a scale of 0-10. The patients' fever status, restlessness, inappetence, and sleeplessness scores were asked again to their parents and recorded. total duration of the disease and the duration of restlessness, inappetence, and sleeplessness were recorded.
次要结局
未报告次要终点
研究者
Murat Sutcu
Clinical Professor
Eskisehir Osmangazi University