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This is an observational clinical study to determine the hydration status in subjects with fever visiting the out-patient departments (OPD) utilizing point of care (POC) salivary osmolality testing.

Observational clinical study to determine the hydration status in subjects with fever visiting the out-patient departments (OPD) utilizing point of care (POC) salivary osmolality testing - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/10/074683
Enrollment
410
Registered
2024-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Johnson & Johnson Pte Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age 2 years or older 2) Fever with a digital thermometer per axilla of greater that or equal to 37.5 °C (99.5 °F) 3) Subject confirms they are not pregnant

Exclusion criteria

Exclusion criteria: 1) Critical illness requiring immediate hospitalization 2) Concurrent medical condition that, in the investigatorâ??s opinion, may impact salivary flow rate causing xerostomia or sialorrhoea 3) Gastro-intestinal symptoms such as nausea, vomiting, diarrhoea 4) Inability to produce saliva sample 5) Concomitant use of medication that is likely to impact saliva production (e.g., anticholinergics) 6) In the investigatorâ??s opinion the subject is unable to comply with study procedures or has a condition which may impact study outcomes

Design outcomes

Primary

MeasureTime frame
Proportion of dehydrated subjects with feverTimepoint: At single visit only

Secondary

MeasureTime frame
â?¢ Proportion of each degree of dehydration i.e., mild, moderate, or severe in adult subjects â?¢ Correlation of salivary osmolarity with body temperature. â?¢ Correlation of salivary osmolarity with age, gender, duration of fever â?¢ Correlation of salivary osmolarity with subjectsâ?? fluid/electrolyte drink during the illness â?¢ Proportion of muscle soreness or muscle cramps (presence or absence) in patients with fever â?¢ Proportions of fatigue & its severity in adult patients with fever â?¢ Proportion of dehydration related clinical symptoms & signsTimepoint: At single visit only

Countries

India

Contacts

Public ContactDr Jogesh Mahajan

Lambda Therapeutic Research Ltd

namanshah@lambda-cro.com07940202214

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026