A Real World Evidenced Study to understand the effect Sodium Alginate antacid combination on quality of life, Tolerability and effectiveness in GERD patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Proportion of GERD patient achieving improvement in the quality of life
研究概览
简要总结
This is a Retrospective observational real world evidence data retrieval study planned with an objective to understand the effect of sodium Alginate combination on quality of life , Tolerability and effectiveness on Gerd patients were received in the past .This retrospective data retrieval study will conducted across pan India centers. The overall data retrieval for this study is 10,000 patients who had received Sodium Alginate antacid suspension for the treatment of GERD.The data retrieval of the medical record form were done from the physician of the patients who had received Sodium alginate antacid for the treatment of GERD.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
入选标准
- •Ages: ≥ 18 years
- •Genders Eligible for Study: both Males and Females
- •Patients who received oral Sodium alginate antacid suspension in the past for the management of GERD as per the local prescription data.
排除标准
- •Patients those who had not received sodium alginate antacid suspension as per the local prescription data.
结局指标
主要结局
Proportion of GERD patient achieving improvement in the quality of life
时间窗: Proportion of GERD patient having treatment related side effects on day 7
次要结局
- To evaluate the efficacy and safety profile of the patient who had(received sodium alginate antacid)
- Proportion of GERD patient having treatment related side effects on day 7(From the Baseline to the 7 day after the treatment initiation)
研究者
Dr Dinesh Patil MBBS MD
Alembic Pharmaceuticals Limited