Comparative evaluation of the Efficacy of Omeprazole, Vonoprazan Combined with Melatonin and Vonoprazan monotherapy in the Management of Gastroesophageal Reflux Disease (GERD)- A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- severity scores of heartburn and epigastric pain
研究概览
简要总结
This pilot study will aim to compare the efficacy and safety of three therapeutic approaches in the management of gastroesophageal reflux disease (GERD): omeprazole combined with melatonin, vonoprazan combined with melatonin, and vonoprazan monotherapy. Adult participants diagnosed with GERD will be enrolled and allocated into one of the three treatment arms. The study will evaluate improvements in symptom severity using the Frequency Scale for the Symptoms of GERD (FSSG) and assess changes in quality of life through validated scales. The incidence and severity of treatment-emergent adverse events will also be documented. This study will seek to determine the most effective and tolerable regimen for GERD symptom relief, with the goal of informing clinical decision-making in the Indian healthcare setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants who will be diagnosed with gastroesophageal reflux disease, confirmed by an FSSG score of less than 32, and who will be experiencing symptoms such as heartburn or regurgitation at least two or more days per week will be included.
- •Participants will either be prescribed omeprazole or vonoprazan and will be willing to take melatonin if required during the study.
- •All participants who will provide written informed consent and adhere to the study protocol.
排除标准
- •Participants were excluded if they had a known hypersensitivity to omeprazole, vonoprazan, or melatonin, or if they had peptic or duodenal ulcers diagnosed through endoscopy.
- •The exclusion criteria also included the concomitant use of medications known to interact significantly with the study drugs (e.g., fluvoxamine), the use of traditional medicines for GERD, presence of a hiatus hernia, refusal to follow dietary advice, or severe symptoms indicated by an FSSG score greater than 32.
结局指标
主要结局
severity scores of heartburn and epigastric pain
时间窗: 2 weeks and 4 weeks
次要结局
- patient-reported quality of life and TEAE(2 weeks and 4 weeks)
研究者
Dr Dharmander Singh
Hakim Abdul Hameed Centenary Hospital