| CTRI Number |
CTRI/2024/06/068824 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of Nerve Conduction Velocity in Normal, Overweight and Obese Subjects. |
|
Scientific Title of Study
|
A study of Nerve Conduction Velocity in Normal, Overweight and Obese Subjects and its association with Dyslipidemia. |
| 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 Rishav Raj |
| Designation |
Junior Resident (PG) |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Physiology
Maulana Azad Medical College
New Delhi
Maulana Azad Medical College
New Delhi
Central
DELHI
110002
India |
| Phone |
9891619758 |
| Fax |
|
| Email |
rishavrj784@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mona Bedi |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Physiology
Maulana Azad Medical College
New Delhi
Maulana Azad Medical College
New Delhi
Central
DELHI
110002
India |
| Phone |
9990499927 |
| Fax |
|
| Email |
drmonabedi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mona Bedi |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Physiology
Maulana Azad Medical College
New Delhi
Maulana Azad Medical College
New Delhi
DELHI
110002
India |
| Phone |
9990499927 |
| Fax |
|
| Email |
drmonabedi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College
Bahadurshah zafar marg
New Delhi-110002
India
|
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College
Bahadurshah zafar marg,
New Delhi- 110002
India |
| 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 Rishav Raj |
Maulana Azad Medical College |
NCV Lab
Department of Physiology
Central
DELHI |
9891619758
rishavrj784@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 |
Overweight and Obese |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Normal, Overweight and Obese Subjects with no co-morbidities as per Asia-pacific Guidelines |
|
| ExclusionCriteria |
| Details |
1) Individuals having symptoms of Neuropathy.
2) Having history of any known cause of Peripheral Neuropathy.
3) Pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nerve Conduction velocity in Normal, Overweight and Obese. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determine dyslipidemia as possible cause of Peripheral Neuropathy. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/07/2024 |
| 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) |
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
|
In the present research we aim to study the Nerve conduction velocity in Normal, Overweight and Obese subjects and its association with dyslipidemia. The study will be conducted in the nerve conduction velocity Lab of Department of Physiology MAMC New delhi. Lipid profile will be assessed in the Biochemistry lab of the MAMC and LN hospital. |