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Establishment of reference interval for Indian Population

Taskforce on Establishment of Reference Intervals in Indian Population (TERIIP): A Multi-Centric Observational Cross Sectional Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/085038
Enrollment
25500
Registered
2025-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

None listed

Interventions

Intervention1: NIL: NIL

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: o Healthy volunteers (males and females) aged 18 years and above o Health Status: Participants must be physically and mentally healthy, as assessed using a standardized questionnaire o BMI: Participants must have a normal BMI, as per Indian standards (18 - 23 kg/m2) o Participants must provide informed consent to participate in the study

Exclusion criteria

Exclusion criteria: o Known chronic illness, carrier state HIV, HCV, HBV or acute infection at the time of recruitment. o Female participants who are pregnant, breastfeeding till within one month of enrolment, or within one year after childbirth. o History of Blood Loss or Transfusion: Participants with a history of significant blood loss or blood transfusion within the past 3 months. o Participants who use nicotine in any form o Participants on special diets for more than one month prior to sample collection. o Participants who have taken antibiotics, analgesics, antacids, or anti-allergic medications within the past 35 days. o Women who have taken contraceptive pills within the past 45 days. o Participants who have performed moderate or severe physical exercise within the past 3 days o Women with irregular or painful menstruation. o Participants consuming Multi-Vitamin and mineral supplementation for long duration more than 12 weeks on a regular basis. o Participants who have been hospitalized within the past year. o Participants with participation in another research study involving any investigational product in the past 12 weeks. o Participants consuming alcohol on a regular basis

Design outcomes

Primary

MeasureTime frame
Robust RIs applicable across the Indian population. Identification of age and gender based variation with biological reference interval Identification of regional or demographic variations.Timepoint: End of the study

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactVijetha Shenoy Belle

Kasturba Medical College Manipal

vijetha.shenoy@manipal.edu09844667820

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026