Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Eradication rate of helicobacter pylori infection
研究概览
简要总结
This study intends to assess the possible effectiveness and safety of Diosmin and Hesperidin combination in patients with Helicobacter pylori Infection through evaluating its effect on stool antigen test and serum levels of inflammatory biomarkers as(TNF-A and MDA).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed H. pylori infection through stool antigen test.
- •Patients did not receive prior eradication therapy.
- •Male and female.
- •Age of 18-75 years old.
- •Good mental well-being to clearly understand the study's objectives, advantages and procedures.
排除标准
- •Age less than 18 years.
- •Patients with previous H. pylori eradication therapy.
- •Patients with hypersensitivity/allergy to the study medications.
- •Patients with history of using proton pump inhibitor, H2-blocker, antibiotics that affect H.
- •pylori in the last month.
- •Patients with history of using diosmin and/or hesperidin in the last month.
- •Patients with history of gastric tumor or gastrointestinal (GI) surgery.
- •Patients with concomitant severe disorders; cardiovascular, pulmonary, renal or hepatic, or active malignancy.
- •Pregnancy or breastfeeding.
- •History of drug misuse or recent alcohol consumption.
- •Patients with gall bladder disorders.
- •Patients on blood thinning agents (warfarin, clopidogril, aspirin, etc), anticonvulsants (carbamazepine and phenytoin), muscle relaxants (chlorzoxazone) and NSAID (diclofenac) in order to avoid potential pharmacodynamic and pharmacokinetic drug interactions with diosmin.
- •Patients on anti-inflammatory drugs and antioxidant drugs.
- •Patients with inflammatory conditions (ulcerative colitis, rheumatoid arthritis, etc.).
- •Patients with conditions associated with oxidative stress (smoking, COPD, etc.).
研究组 & 干预措施
Group 1 (placebo group)
Patients will receive standard triple therapy (Omeprazole 20 mg cap PO BID + Clarithromycin 500 mg tab PO BID + Amoxicillin 1000 mg PO BID) and placebo tab PO BID for 14 days
干预措施: Placebo (Drug)
Group 2 (intervention group)
Patients will receive standard triple therapy (Omeprazole 20 mg cap PO BID + Clarithromycin 500 mg tab PO BID + Amoxicillin 1000 mg PO BID) and Diosmin/Hesperidin (Daflon®) 500mg tab PO BID for 14 days.
干预措施: Daflon (Drug)
结局指标
主要结局
Eradication rate of helicobacter pylori infection
时间窗: At baseline and after 6 weeks of initiation of therapy
The primary outcome is the improvement of eradication rate of H. pylori infection which is measured by stool antigen test (Negative result).
次要结局
- Inflammatory biomarkers suppression(At baseline and after 6 weeks of initiation of therapy)
研究者
Aya Mosaad Zaki Swidan
Demonstrator
Sadat City University