Prospective, Randomized, Comparative, Parallel Group, Study to evaluate the Safety and Efficacy of ORS of Mystical Biotech Pvt Ltd versus Traditional marketed ORS in subjects with Diarrhea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of subjects with resolution of dehydration after initiating ORS treatment until end of study treatment.
研究概览
简要总结
This Observational study clinical study is designed as a prospective, randomized, comparative study, that aims to evaluate the safety and efficacy of ORS in comparison to a Traditional Marketed ORS in subjects diagnosed with acute diarrhea. The trial will adopt a parallel-group design and will be conducted across multiple clinical centres. A total of 60 eligible subjects diagnosed with acute diarrhea will be enrolled. Subjects will be randomized in a 3:1 ratio, with 45 subjects assigned to the intervention group receiving ORS and 15 subjects allocated to the comparator group receiving Traditional Marketed ORS. Subjects in the intervention arm will be administered ORS in accordance with recommended dosing guidelines. Subjects in the comparator arm will receive Traditional Marketed ORS, following the dosing instructions provided by the manufacturer. All enrolled subjects, regardless of their assigned treatment group, will receive the established standard of care for diarrhea management. This includes guidance on dietary modifications and the provision of supportive care as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •1.Participants of either gender, aged 18-60 years (both inclusive).
- •2.Willing to comply with the study procedures and provide written informed consent.
- •3.Acute diarrhea, defined as the passage of three or more loose or watery stools in a 24-hour period, lasting for less than 72 hours.
- •4.Ability to provide informed consent.
排除标准
- •1.Chronic diarrhea (lasting for more than 72 hours).
- •2.Presence of severe dehydration requiring immediate intravenous fluid replacement.
- •3.Known hypersensitivity to any components of the investigational ORS or traditional marketed ORS.
- •4.History of significant gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome).
- •5.Use of antibiotics or any anti-diarrhoeal medication in the previous 2 weeks.
- •6.Use of pre-/probiotics in the previous 1 week 7.Participation in another clinical trial within the past 30 days.
- •8.Underlying severe medical conditions (e.g., renal, cardiac, hepatic) that could affect hydration status or complicate assessment of study outcomes.
- •9.Use of medications that could interfere with the study outcomes (e.g., antidiarrheal drugs).
- •10.Any other medical condition or circumstance that, in the opinion of the investigator, would compromise the safety or compliance of the subject or the quality of the data.
- •11.Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
结局指标
主要结局
Proportion of subjects with resolution of dehydration after initiating ORS treatment until end of study treatment.
时间窗: Baseline to EOT(up to 6days)
次要结局
- To compare the time to resolution of diarrhea symptoms between the investigational ORS and traditional marketed ORS.(To assess subject satisfaction and preference for the investigational ORS versus traditional marketed ORS.)
研究者
Dr Nutan Kumar Agrawal
MLB Medical college