Study to Determine the Effectiveness of ORSL�® variants as an Adjuvant to help restore Oral Fluid, Electrolytes and Energy (FEE) Along With Standard of Care Medication Treatment inRecovery for Subjects With Fever And/Or General Weakness in Out-Patient Setting Among the Indian Populatio

Phase 4

• Conditions: Health Condition 1: R509- Fever, unspecifiedHealth Condition 2: R538- Other malaise and fatigueHealth Condition 3: R508- Other specified fever

• Registration Number: CTRI/2021/10/037363
• Lead Sponsor: Johnson and Johnson Pte Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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 <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 ORSL�®variants as adjuvant and/or any other ready to drink solution in the last 48 hours.

- Use of any medications which might interact with ORSL�® 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

- 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified