| CTRI Number |
CTRI/2024/10/074683 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PROTOCOL no:CCSNAP005415, VERSION:03,Date -12 Feb 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jogesh Mahajan |
| Designation |
Senior Vice President |
| Affiliation |
Lambda Therapeutic Research Limited |
| Address |
Lambda House, Department of Clinical Research, Room No. NA,
Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway,
Gota Ahmadabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202214 |
| Fax |
07940202021 |
| Email |
jogeshmahajan@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naman Shah |
| Designation |
Senior General Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Lambda House, Plot No. 38, Survey no. 388,Near Silver Oak Club,S. G. Highway, Gota Ahmadabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202214 |
| Fax |
07940202021 |
| Email |
namanshah@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jogesh Mahajan |
| Designation |
Senior Vice President |
| Affiliation |
Lambda Therapeutic Research Limited |
| Address |
Lambda House, Plot No. 38, Survey no. 388,Near Silver Oak Club,S. G. Highway, Gota Ahmadabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202214 |
| Fax |
07940202021 |
| Email |
jogeshmahajan@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Johnson & Johnson Pte Ltd, with offices at 2 Science Park Drive, Singapore Science Park 1, Ascent, #07-13, Singapore 118222 |
|
|
Primary Sponsor
|
| Name |
Johnson & Johnson Pte Ltd |
| Address |
2 Science Park Drive, Singapore Science Park 1, Ascent, #07-13, Singapore 118222 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Janani shankar |
Kanchi Kamakoti CHILDS Trust Hospital |
12 A, Nageswara Rd, Tirumurthy Nagar, Nungambakkam, Chennai, Tamil Nadu 600034
Chennai
TAMIL NADU |
9841078101
janani.sankar@yahoo.com |
| Dr Sheik Md Minhajuddin Ahmed |
Lord Health Care (Nursing Home) |
(A Unit Of MJJ Enterprise Pvt. Ltd), 13/3, Circular 2nd Bye Lean , Shibpur, Howrah-711102
Haora
WEST BENGAL |
8637833074
drminhajuddin@ymail.com |
| Dr Ram Sabad Raman |
Maharaja Agrasen Hospital |
Department of clinicl research,Maharaja Agrasen Hospital 1, Jain Muni Guru Ramkrishan Marg, Near Metro Station Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, Delhi, 110026
North
DELHI |
9312702643
dr.rs.raman.2005@gmail.com |
| Dr Bhavesh Makwana |
Raneshwar Multispetiality Hospital |
Department of clinicl research,A-4 Parshaw Nagar Society Vasna Road Before Vasna, Ravi Park Society, Saiyed Vasna, Vadodara, Gujarat 390015
Vadodara
GUJARAT |
9824058398
bhaveshkirtu@yahoo.co.in |
| Dr Sachin Gupta |
Shubham Multispeciality Hospital |
Department of clinical research,B/89/93, Rabari Colony, Amraiwadi, Ahmedabad, Gujarat 380038
Ahmadabad
GUJARAT |
9898012300
drsachingupta_21@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Hurip Indepenent Bioethics Committee, Dr, Sheik Md Minhajuddin Ahmed |
Approved |
| Institutional Review Board Ethics Committee of Kanchi Kamakoti CHILDS Trust Hospital and The CHILDS Trsut Medical Research Foundation, Dr Janani shankar |
Approved |
| IRB Raneshwar Multispeciality Hospital, Dr. Bhavesh Makwana |
Approved |
| Maharaja Agrasen Hospital Institutional Ethics Com, Dr. Ram Sabad Raman |
Approved |
| Shubham Institutional Ethics Committee,Dr. Sachin Gupta |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
1) Critical illness requiring immediate hospitalization
2) Concurrent medical condition that, in the investigator’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 investigator’s opinion the subject is unable to comply with study procedures or has a condition which may impact study outcomes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of dehydrated subjects with fever |
At single visit only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Proportion of each degree of dehydration i.e., mild, moderate, or severe in adult subjects
• Correlation of salivary osmolarity with body temperature.
• Correlation of salivary osmolarity with age, gender, duration of fever
• Correlation of salivary osmolarity with subjects’ fluid/electrolyte drink during the illness
• Proportion of muscle soreness or muscle cramps (presence or absence) in patients with fever
• Proportions of fatigue & its severity in adult patients with fever
• Proportion of dehydration related clinical symptoms & signs |
At single visit only |
|
|
Target Sample Size
|
Total Sample Size="410"
Sample Size from India="410"
Final Enrollment numbers achieved (Total)= "223"
Final Enrollment numbers achieved (India)="223" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2024 |
| Date of Study Completion (India) |
30/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary: • To assess the hydration status of subjects with fever Secondary: • To assess the degree of dehydration i.e., mild, moderate, or severe in adult subjects • To assess the correlation of hydration status with body temperature. • To assess the correlation of hydration status with age, gender, duration of fever • To assess the correlation of hydration status with subjects’ fluid/electrolyte drink during the illness |