| CTRI Number |
CTRI/2026/01/100815 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of tobacco smoking on brain function in adult smokers |
|
Scientific Title of Study
|
Association of serum cotinine level with cognitive function in chronic smokers |
| 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 Dhairya Rathod |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 205 2nd floor Department of Biochemistry Pathology Block Maulana Azad Medical College New Delhi
Central
DELHI
110002
India |
| Phone |
7574993065 |
| Fax |
|
| Email |
rathod.dhairya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Kaushik |
| Designation |
Director Professor & HOD |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 211 2nd floor Department of Biochemistry Pathology Block Maulana Azad Medical College New Delhi
Central
DELHI
110002
India |
| Phone |
9968604230 |
| Fax |
|
| Email |
smitakaushik77@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhairya Rathod |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 205 2nd floor Department of Biochemistry Pathology Block Maulana Azad Medical College New Delhi
Central
DELHI
110002
India |
| Phone |
7574993065 |
| Fax |
|
| Email |
rathod.dhairya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,2 Bahadur Shah Zafar Marg 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, New Delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Biochemistry |
Maulana Azad Medical College New Delhi 110002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhairya Rathod |
Maulana Azad Medical College |
Room no 205 2nd floor Department of Biochemistry Pathology Block Maulana Azad Medical College New Delhi
Central
DELHI |
7574993065
rathod.dhairya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital(Lok Nayak, G.I.P.M.E.R.,Guru Nanak Eye Centre, New Delhi-110002) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Group A: Chronic tobacco smokers between ages of 30 and 55 years smoking greater than 10 cigarette and or bidi per day for 10 years or more.
Group B: Age and gender matched healthy non smoker volunteers.
|
|
| ExclusionCriteria |
| Details |
Group A:
1. Any history of known psychiatric illness
2. Any medical condition or history of serious head injury that is known to influence cognition
3. History of using nicotine replacement therapy.
4. Recent history of alcohol consumption or any psychotropic medications or drugs (up to 3 months).
Group B:
1. Previous history of tobacco use in any form
2. Any medical condition or history of serious head injury that is known to influence cognition
3. Recent history of alcohol consumption or any psychotropic medications or drugs (up to 3 months). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Mean Serum cotinine levels(ng/mL) in chronic smokers and healthy non-smokers.
2.Proportion of different Cognitive function scores in both the groups.
3.Association of serum cotinine levels with cognitive function scores. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean difference in Serum levels of Iron(µg/dL), Ferritin(ng/mL), TIBC(µg/dL), CRP(mg/L), IL-6(pg/mL), Vitamin B12(pg/mL), Folate(ng/mL), & Homocysteine(µmol/L) in chronic smokers & healthy non smokers. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The primary aim of this study is to assess the association between serum cotinine levels and cognitive function in chronic tobacco smokers. Cognitive function will be evaluated using Addenbrooke’s Cognitive Examination-III, and serum cotinine along with other biochemical parameters will be measured and compared with age- and gender-matched healthy non-smokers. |