The Effect of Propolis and Nutritional Education in Patients With H. Pylori on Gastrointestinal Symptoms
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 96
- 主要终点
- Gastrointestinal Symptom Rating Scale
研究概览
简要总结
This research aims to contribute to the literature by researching the effect of propolis as an add-on treatment and nutritional education on patients with H pylori and the alleviation of gastrointestinal symptoms.In order to achieve this, we offered propolis and educational nutrion programme to our 96 patients and check on their symptoms on a regular basis to note any improvement by measuring the alleviation using GSRS.
详细描述
The informed voluntary consent was taken from the patients who agreed to attend the research and the patients, Group 1 propolis with lactic acid extract on top of the treatment given by doctor Group 2 Lactic acid extract on top of the treatment by the doctor Group 3 the treatment given by the doctor and placebo treatment ,will be distributed by the method of randomized double blind trial.The patients will be provided with 500 mg (≌60 drops/day) of propolis or propolis with lactic acid extract in the morning,afternoon and evening for 14 days.The face-to-face Survey data collection method will be utilized and the researcher inform the patients about the diet and nutrition education against pylori and propolis.The presentation for the Patient Education and Propolis is given in the appendix.
The survey form consists of 4 parts; descriptive general information,eating habits,Gastrointestinal Symptoms Rating Scale (GSRS) and the frequency of The consumption of particular food. In order to rate the gastrointestinal symptoms of the patients the GSRS scale which was validated and deemed reliable in Turkish will be used The foods that increase the frequency of gastrointestinal symptoms such as spicy foods,chocolate,Chips,carbonated drinks,citrus fruits are also questioned in terms of frequency of consumption.
In order to investigate the patients adherence to the study, reminders will be taking place by giving them a call two times a week. At the end of the intervention period,GSRS scale will be reused to assess the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind randomized controlled trial study will be utilized.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The detection of H pylori infection by a specialized physician.
排除标准
- •Bees and bees products allergies and the patients who use drugs that has bleomycin as an active compound will be excluded as it was found in the rats that these types of antitumor drugs can interact with propolis
研究组 & 干预措施
Group 1
Group 1 propolis with lactic acid extract on top of the treatment given by doctor
干预措施: propolis solved in lactic acid solvent (Dietary Supplement)
Group 1
Group 1 propolis with lactic acid extract on top of the treatment given by doctor
干预措施: Amoxicillin-Clarithromycin-Lansoprazole (Drug)
Group 2
Grorup 2 Lactic acid extract on top of the treatment by the doctor
干预措施: Lactic acid (Other)
Group 2
Grorup 2 Lactic acid extract on top of the treatment by the doctor
干预措施: Amoxicillin-Clarithromycin-Lansoprazole (Drug)
Group 3
Group 3 the treatment given by the doctor and placebo treatment
干预措施: Amoxicillin-Clarithromycin-Lansoprazole (Drug)
Group 3
Group 3 the treatment given by the doctor and placebo treatment
干预措施: IV saline 0.9% (Other)
结局指标
主要结局
Gastrointestinal Symptom Rating Scale
时间窗: 14 days
The follow up of the patients are done by Gastrointestinal Symptom Rating Scale
次要结局
未报告次要终点
研究者
Fatma Zehra Arvas
dietitian
Medipol University