NCT02018328Unknown不适用
The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection
Gingold Belfer Rachel2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Urea breath test
研究概览
简要总结
Background and Aims
- H.pylori is a common human pathogen by which almost 50% of the world population is infected. According to the accepted guidelines, once H.pylori infection has been diagnosed,first line therapy with three drugs should be given. The triple treatment includes proton-pump-inhibitor-clarithromycin-amoxicillin but its eradication rate is only 70-80%.
- Curcumin has many beneficial merits and it was also been demonstrated to be efficient in inhibition of H.pylori infection, in vitro.Therefore we aim to investigate whether addition of Curcumin to the standard triple therapy will increase the eradication rate of H.pylori infection.
Methods
- 150 consecutive patients that will undergo esophagogastroscopy in our Gastroenterology department and will be positive for H.pylori according to urease test and then by gastric biopsy, will be included. The patients will be randomized to two different treatments, according to binomial distribution. 75 patients will be treated with the standard triple therapy for 10 days and the other 75, will be treated for 10 days, with triple therapy combined with Curcumin that will be given three times a day.
- During the treatment the patients will complete an adverse effect's questionnaires. 6 weeks after the completion of the treatment the patients will undergo urea breath test to confirm eradication. Patients will be asked to avoid antibiotics, bismuth compounds or proton-pump-inhibitor until the second urea-breath-test.
- We will compare the eradication rate and the adverse effects between the two groups by using SPSS
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •positivity for Helicobacter pylori by urease test and gastric biopsy
排除标准
- •prior treatment for H. pylori
- •allergy to penicillin
- •gastric outlet obstruction
- •pregnancy or breast feeding
- •inability to understand the informed consent
研究组 & 干预措施
Triple therapy, helicobacter pylori
No Intervention
triple therapy+curcumin helicobacter pylori
Experimental
Curcumin will be added to the regular triple therapy
干预措施: Curcumin (Dietary Supplement)
结局指标
主要结局
Urea breath test
时间窗: 6 weeks after the completion of the treatment
次要结局
未报告次要终点
研究者
Gingold Belfer Rachel
MD
Rabin Medical Center
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Effects of highly-bioavailable curcumin for periodontitis: a randomized, double-blind, placebo-controlled prospective studyChronic periodontitisJPRN-UMIN000018867Department of Periodontology Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University90
招募中
3 期
The effect of curcumin on the treatment of human papillomavirus infectioCervical human papilloma virus infection.IRCT20220629055314N1Arak University of Medical Sciences90
已完成
3 期
Evaluation of curcumin effect on prevention of hepatotoxicitycancer.Malignant neoplasm of central portion of breastC50.1IRCT20190918044815N1Esfahan University of Medical Sciences60
Unknown
2 期
An invivo study to evaluate the role of curcumin in oral pre-malignant lesions and gingivo-buccal cancersCTRI/2008/091/000193DBT90
招募中
不适用
evaluation of Curcuma tablet efficacy in nonalcoholic fatty liver patientsnonalcoholic fatty liver.Fatty (change of) liver, not elsewhere classifiedIRCT20170722035222N2Esfahan University of Medical Sciences100
