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 - NI

Ms Mystical Biotech Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•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.

•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.

发起方

Ms Mystical Biotech Pvt Ltd