Alginate vs Sucralfate for GERD Symptomatic Relief in Combination With PPIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Quality of Life in Reflux and Dyspepsia
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus.It can also present in an atypical manner such as chest pain, dental erosions, chronic cough, laryngitis, or asthma i.e. extra gastroesophageal symptoms. Sucralfate is a unique anti-ulcer drug and is a basic aluminum salt of sucrose octa-sulfate. It forms a protective layer, enhancing bicarbonate production, demonstrating anti-peptic properties, and fostering tissue growth, regeneration, and repair and it undergoes minimal enteral reabsorption. Alginate is a naturally occurring anionic polymer typically obtained from brown seaweed and has been extensively investigated and used for many biomedical applications, due to its biocompatibility, low toxicity, relatively low cost, and mild gelation by addition of divalent cations such as Ca2+.Both sucralfate and alginate have been in use for the treatment and symptomatic relief of GERD and are well tolerated oral formulations.
详细描述
Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus. It is one of the most commonly diagnosed digestive disorders in the young adult population with a prevalence of 20%. Clinically GERD typically manifests with symptoms of heartburn and regurgitation. It can also present in an atypical manner such as chest pain, dental erosions, chronic cough, laryngitis, or asthma i.e. extra gastroesophageal symptoms. Several causative factors have been identified and implicated in the pathogenesis of GERD, like motor abnormalities such as esophageal dysmotility clearance, decrease tone of the lower esophageal sphincter (LES), transient LES relaxation, and delayed gastric emptying, and others are anatomical defects like hiatus hernia and obesity Sucralfate is a unique anti-ulcer drug and is a basic aluminum salt of sucrose octa-sulfate. It forms a protective layer, enhancing bicarbonate production, demonstrating anti-peptic properties, and fostering tissue growth, regeneration, and repair and it undergoes minimal enteral reabsorption. Alginate is a naturally occurring anionic polymer typically obtained from brown seaweed and has been extensively investigated and used for many biomedical applications, due to its biocompatibility, low toxicity, relatively low cost, and mild gelation by addition of divalent cations such as Ca2+.Alginate reacts with gastric acid, forming a gel-like raft that floats on the stomach contents. The raft acts as a physical barrier, preventing acid from reaching the esophagus. Both sucralfate and alginate have been in use for the treatment and symptomatic relief of GERD and are well tolerated oral formulations. This randomized clinical trial will oversee the effects of alginates versus sucralfate for GERD symptomatic relief in combination with proton pump inhibitors.
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 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients having symptoms of severe GERD for more than 3 times /week
排除标准
- •Patients with preexisting cardiovascular disorders
- •Patients with chronic kidney or liver diseases
- •Patients with gross abnormalities on upper GI endoscopies e.g.; ulcers, tumors or those with history of upper GI surgery
- •Pregnant and breast feeding
- •Absence of Erosive esophagitis
- •Patients with peptic esophageal ulcers
- •PPI use within 4 weeks
研究组 & 干预措施
Alginate Group
Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS.
干预措施: Alginate (Drug)
Sucralfate Group
Patient meeting the eligibility criteria will be given two tablespoons before meal twice a day along with PPIS.
干预措施: Sucralfate (Drug)
结局指标
主要结局
Quality of Life in Reflux and Dyspepsia
时间窗: Before Treatment, At 4 weeks, At 6 Weeks
This involves questionnaire related to the symptoms and impact on quality of life. The total score is 140, ranging from 0 to 140, the higher the score the worse will be the symptoms.
次要结局
- Quality of Life (QOLRAD)(Before Treatment, At 2 weeks, At 4 Weeks)
- Adverse Effects and Tolerability(Before Treatment, At 2 weeks, At 4 Weeks)
- Gerd Symptom Severity(Before Treatment, At 2 weeks, At 4 Weeks)
