Health Condition 1: K928- Other specified diseases of the digestive system Health Condition 2: R198- Other specified symptoms and signsinvolving the digestive system and abdomen
Conditions
Interventions
Intervention1: ORS (Intervention made by Mystical Biotech Pvt Ltd.): Dose: 2.3 gm, route of administration: Oral, frequency: 2 sachets per day, Duration of therapy: Up to 6 days
Control Intervention1:
Sponsors
Ms Mystical Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with resolution of dehydration after initiating ORS treatment until end of study treatment.Timepoint: Baseline to EOT(up to 6days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. To analyze the frequency of adverse events and adverse reactions between the two treatment groups.Timepoint: baseline to Day 9 | — |
Countries
India
Contacts
Public ContactBridreth khokhare
Abiogenesis Clinpharm Private Limited
Outcome results
None listed