| CTRI Number |
CTRI/2025/07/091639 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on Brain function and Blood marker changes in adults addicted to the internet |
|
Scientific Title of Study
|
Neurocognitive functions and Blood biomarker levels in adults with internet addiction |
| 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 Varnica Gupta |
| Designation |
Junior Resident (PG) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology,
Maulana Azad Medical College,
Bahadurshah Zafar marg,
New Delhi
Maulana Azad Medical College,
Bahadurshah Zafar marg,
New Delhi
Central
DELHI
110002
India |
| Phone |
7032141031 |
| Fax |
|
| Email |
varnicagupta20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Jain |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology,
Maulana Azad Medical College,
Bahadurshah Zafar marg,
New Delhi
Maulana Azad Medical College,
Bahadurshah Zafar marg,
New Delhi
Central
DELHI
110002
India |
| Phone |
9968604354 |
| Fax |
|
| Email |
preetijaincell@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Jain |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology,
Maulana Azad Medical College,
Bahadurshah Zafar marg,
New Delhi
Maulana Azad Medical College,
Bahadurshah Zafar marg,
New Delhi
DELHI
110002
India |
| Phone |
9968604354 |
| Fax |
|
| Email |
preetijaincell@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadurshah zafar marg,
New Delhi
India
pincode-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadurshah Zafar Marg,
New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Varnica Gupta |
Maulana Azad Medical College |
Department of Physiology,
Maulana Azad Medical College,
New Delhi.
Central
DELHI |
7032141031
varnicagupta20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Maulana Azad Medical College and associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
internet addiction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with internet addiction (Internet addiction would be determined by a score of more than 30 based on Young’s internet addiction test). |
|
| ExclusionCriteria |
| Details |
1. Subjects having a history of neurological or musculoskeletal disorders.
2. Subjects having a history of any auditory or visual problems.
3. Subjects having any acute physical or mental illness.
4. Subjects who are taking any medication that is likely to affect cognition (e.g.,
sedatives, antihistamines, antipsychotics, certain antidepressants).
5. Subjects who have history of substance abuse disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of mean latency and amplitude of P300 in cases and controls |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of the mean neuropsychological test scores in cases and controls.
|
Baseline |
| Comparison of the blood Tau level in cases and controls. |
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)
|
15/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 present study will be conducted in the Neuro-physiology lab of department of Physiology, Maulana Azad Medical College, New Delhi. The study is designed to assess the Neuro-cognitive functions and blood biomarker (Tau Protien) in adults with internet addiction and to compare the parameters with those of subjects without internet addiction. |