Health Condition 1: R509- Fever, unspecified Health Condition 2: R538- Other malaise and fatigue Health Condition 3: R508- Other specified fever
Conditions
Interventions
Intervention1: ORSLÃ?® Apple Drink: Food products classified as ââ?¬Å?Electrolyte Drinkââ?¬?.
Administration: ORSL�® Apple Drink Packs to be consumed orally based on physicianâ��s recommend
Sponsors
Johnson and Johnson Pte Limited
Eligibility
Inclusion criteria
Inclusion criteria: - Subjects �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 - 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
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 - Subjects presenting with a urinary tract infection (UTI) - Subjects who, in the Investigatorââ?¬•s opinion, are not suitable to take part in the study - Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., Principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson & Johnson subsidiaries, contractors of Johnson & Johnson, and the families of each)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess improvement in energy or hydration levels after ORSLÃ?® variants consumptionTimepoint: 6 hours, 24 hours and 48 hours (compared to baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess improvement in both energy and hydration levels after ORSLÃ?® variants consumptionTimepoint: 20 minutes, 40 minutes, 60 minutes, 6 hours, 24 hours and 48 hours as compared to baseline;To assess improvement in energy or hydration levelsTimepoint: 20 minutes, 40 minutes, 60 minutes, 6 hours, 24 hours and 48 hours, after ORSLÃ?® Apple Drink and ORSLÃ?® PLUS Orange Drink consumption, separately (as compared to baseline);To assess improvement in energy or hydration levels after ORSLÃ?® variants consumptionTimepoint: 20 minutes, 40 minutes, 60 minutes as compared to baseline;To measure ORSLÃ?® variants consumptionTimepoint: 72 hours;To understand the physicianââ?¬â?¢s experience of recommendation with ORSLÃ?® variantsTimepoint: 72 hours;To understand the subjectââ?¬â?¢s experience with ORSLÃ?® variantsTimepoint: 72 hrs | — |
Countries
India
Contacts
Public ContactDr Priti Thakor
Johnson and Johnson Pte. Limited
Outcome results
None listed