| CTRI Number |
CTRI/2024/02/062598 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Research on the conversion of cotinine back into nicotine in human plasma |
|
Scientific Title of Study
|
Investigation of the mechanism and enzyme responsible for the conversion of cotinine back to nicotine using human plasma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Murugesan Arumugam |
| Designation |
Assistant Professor in Pharmacology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research, Chennai-600116 |
| Address |
Department of Pharmacology, Pharmacology Lab, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8870151588 |
| Fax |
|
| Email |
murugesan.a@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murugesan Arumugam |
| Designation |
Assistant Professor in Pharmacology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research, Chennai-600116 |
| Address |
Department of Pharmacology, Pharmacology Lab, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8870151588 |
| Fax |
|
| Email |
murugesan.a@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Balamurugan S |
| Designation |
PG Pharmacology Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Pharmacology, Pharmacology Lab, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9585092622 |
| Fax |
|
| Email |
balamuruganpharmacology@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research
Sri Ramachandra Nagar, Porur, Chennai-600116, Tamil Nadu State |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research DU |
| Address |
1 Mount Poonamallee Rd Sri Ramachandra Nagar Ramachandra Nager Chennai Tamil Nadu 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Murugesan Arumugam |
Sri Ramachandra Faculty of Pharmacy, Department of Pharmacology, SRIHER |
Out patient Unit, Department of General Medicine, Sri Ramachandra Medical College and Hospital, Sri Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU |
8870151588
murugesan.a@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for Students Project |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic smokers (at least 5 cigarettes or bidi per day) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic smoker
2. patients above 18 years old
3. consumer of other tobacco products such as chewed products, electronic cigarette, etc. |
|
| ExclusionCriteria |
| Details |
1. Patients with no smoking effect
2. Pregnant women
3. Patients taken alcohol within 24 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will estimate and compare the plasma levels of SOD,CAT,GPx in smokers and non somokers |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mechanism of the conversion of cotinine back to nicotine in presence of ascrobic acid |
6 months |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
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.
|