CTRI/2021/10/037363
Active, Not Recruiting
Phase 4
Prospective Interventional Study to Determine the Effectiveness of ORSL�® Variants as an Adjuvant to help restore Oral Fluid, Electrolytesand Energy (FEE) Along With Standard of Care Medication Treatment in Recovery for Subjects With Fever And/Or General Weakness in Out-Patient Setting Among the Indian Population
Johnson and Johnson Pte Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Johnson and Johnson Pte Limited
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects ââ?°Â¥18 years of age
- •\- Able to comprehend and willing to sign an ICF and to comply with all aspects of the study
- •\- Subjects should be willing and able to respond to subjective questions
- •\- Subjects must have scores \<3 in both energy and hydration on the ââ?¬Å?Aided Recovery Scaleââ?¬? at the time of the screening (baseline) visit
- •\- Subjects diagnosed in the preceding two weeks with acute febrile illness (e.g. URTI, viral illness) and/or generalized weakness/fatigue due to acute non\-diarrheal illness
Exclusion Criteria
- •\- Subjects needing in\-patient hospitalisation
- •\- Subjects who have undergone any GI surgeries, which are known to affect absorption anytime in the past
- •\- Women who have a positive pregnancy test at screening
- •\- Subjects with pre\-existing medical conditions that may impact study measurements or ability to comply with study procedures, including but not limited to malabsorption syndrome, congestive heart failure, cirrhosis, hepatic failure, malignancy, sepsis,
- •chronic infections like Tuberculosis, Chronic obstructive pulmonary disease, Syndrome of inappropriate antidiuretic hormone secretion, renal failure, etc.
- •\- Participation in any clinical trials in the last 3 months
- •\- Use of any other oral rehydration solution and/or ORSLÃ?®variants as adjuvant and/or any other ready to drink solution in the last 48 hours.
- •\- Use of any medications which might interact with ORSLÃ?® variants as per physician discretion
- •\- Subjects with nausea, vomiting, diarrhoea, suspected or confirmed malaria, dengue or
- •typhoid confirmed by culture positive test, active COVID\-19 disease, subjects in convalescence post COVID\-19 \<3 weeks and off steroid \<2 weeks
Outcomes
Primary Outcomes
Not specified
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