Post marketing study to assess the efficacy and safety of O2live in enhancing oxygen transportation in healthy volunteers

A Randomized Double-Blind Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of O2live in Enhancing Oxygen Transportation in Healthy Volunteers. - Nill

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079086

Enrollment

Registered

2025-01-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

None listed

Interventions

Intervention1: O2live capsule: Route-Oral, Dose-500(mg), Frequency-BD,Duration-28 days. Control Intervention1: Placebo: Route-Oral, Dose-500(mg), Frequency-BD,Duration-28 days.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male and female volunteers aged 18-65 years. 2. Body Mass Index (BMI) between 18.5 and 24.9 kg/m². 3. Non-smokers and non-alcoholics. 4. No history of cardiovascular, respiratory, or metabolic disorders. 5. Not currently on any medication or supplement known to affect oxygen transportation. 6. Agrees to not participate in any other clinical trials during the course of this trial. 7. Willing to participate in the study and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Individuals with known hypersensitivity to any component of O2live. 3. Participation in any other clinical trial within the last 3 months. 4. Any other condition that the investigator deems inappropriate for participation. 5. Unwillingness to comply with study procedures

Design outcomes

Primary

Measure	Time frame
a) Change in arterial oxygen saturation (SpO2) from baseline to end of study. b) Change in haemoglobin concentration from baseline to end of study.Timepoint: Day 1 and Day 28	—

Secondary

Measure	Time frame
a) Change in total serum anti-oxidant capacity from baseline to end of study. b) Change in Health-Related Quality of Life from baseline to end of study using the 36-Item Short Form Health Survey (SF-36) questionnaire. c) The change from baseline in vital signs (pulse rate, respiratory rate, and body temperature). d) Change from baseline in haematological (CBC) parameters, liver (SGPT & SGOT) and kidney function (Sr. Creatinine) parameters. e) Occurrence of the treatment-related adverse events (AEs) during study period.Timepoint: Day 1 and Day 28	—

Measure

Time frame

a) Change in total serum anti-oxidant capacity from baseline to end of study. b) Change in Health-Related Quality of Life from baseline to end of study using the 36-Item Short Form Health Survey (SF-36) questionnaire. c) The change from baseline in vital signs (pulse rate, respiratory rate, and body temperature). d) Change from baseline in haematological (CBC) parameters, liver (SGPT & SGOT) and kidney function (Sr. Creatinine) parameters. e) Occurrence of the treatment-related adverse events (AEs) during study period.Timepoint: Day 1 and Day 28

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Countries

India

Contacts

Public ContactMr Manik Chaudhuri

Xplora Clinical Research Services Pvt. Ltd

hasan@xplorahealth.com9886012598

Outcome results