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Clinical Trials/CTRI/2024/02/062598
CTRI/2024/02/062598CompletedNot Applicable

Investigation of the mechanism and enzyme responsible for the conversion of cotinine back to nicotine using human plasma

Sri Ramachandra Institute of Higher Education and Research DU1 site in 1 country168 target enrollmentStarted: February 19, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
168
Locations
1
Primary Endpoint
The study will estimate and compare the plasma levels of SOD,CAT,GPx in smokers and non somokers

Study Overview

Brief Summary

Our early clinical study (ICMR Clinical Trial Registry India Registration No: CTRI/2022/12/048600). with smoker’s plasma samples was conclusively prove that the nicotine convert cotinine can be convert back to nicotine using Antioxidant (Ascorbic acid). The study result was the first time in the literature and the exact reason for the conversion of cotinine back to nicotine is uncertain. Interestingly, the conversion of cotinine back to nicotine was not happening in plasma without ascorbic acid or in water, therefore it indicates that some Antioxidant enzyme in plasma will involve and cotinine back to nicotine. Therefore, in this study attempt to explore the enzyme response for the conversion of cotinine back to nicotine in human plasma.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Chronic smoker
  • patients above 18 years old
  • consumer of other tobacco products such as chewed products, electronic cigarette, etc.

Exclusion Criteria

  • Patients with no smoking effect
  • Pregnant women
  • Patients taken alcohol within 24 hours.

Outcomes

Primary Outcomes

The study will estimate and compare the plasma levels of SOD,CAT,GPx in smokers and non somokers

Time Frame: 6 months

Secondary Outcomes

  • mechanism of the conversion of cotinine back to nicotine in presence of ascrobic acid(6 months)

Investigators

Sponsor
Sri Ramachandra Institute of Higher Education and Research DU
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Murugesan Arumugam

Sri Ramachandra Institute of Higher Education and Research, Chennai-600116

Study Sites (1)

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