| CTRI Number |
CTRI/2022/06/043484 [Registered on: 24/06/2022] Trial Registered Prospectively |
| Last Modified On: |
23/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Changes in nerves and muscles of arm due to diabetes |
|
Scientific Title of Study
|
Comparative Study on Neuromuscular Efficiency in Diabetic and Normal Population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaspreet kaur |
| Designation |
Associate Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheswar University of Science and Technology,Hisar
Health Center, Guru Jambheswar University of Science and Technology,Hisar
Hisar
HARYANA
125001
India |
| Phone |
|
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaspreet kaur |
| Designation |
Associate Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheswar University of Science and Technology,Hisar
Health center, Guru Jambheswar University of Science and Technology,Hisar
Hisar
HARYANA
125001
India |
| Phone |
|
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mamta boora |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheswar University of Science and Technology,Hisar
Health center, Guru Jambheswar University of Science and Technology,Hisar
Hisar
HARYANA
125001
India |
| Phone |
8683810061 |
| Fax |
|
| Email |
mamtaboora50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self(Kanika sharma) Guru jambheshwar university of science and technology hisar |
|
|
Primary Sponsor
|
| Name |
Guru jambheshwar university |
| Address |
Depatment of physiotherapy guru Jambheswar University of Science and Technology, Hisar |
| Type of Sponsor |
Research institution |
|
|
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 |
| Kanika sharma |
Guru Jambheshwar University of Science and Technology |
Room No 8, Ground Floor, Health Center,Guru Jambheshwar University of Science and Technology
Hisar
HARYANA |
08571820045
sharmaakanikaa8571@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) At least 5 years post onset of type 2 diabetes
2) Without having any neurological symptoms. |
|
| ExclusionCriteria |
| Details |
1)Major neurological conditions
2)Musculoskeletal disablities
3)Nerve injury and entrapment neuropathies
4)Severe cardiovascular diseases and
Respiratory diseases
5)Presence of thyroid, rheumatoid arthritis and autoimmune disease
6)Smokers and alcoholics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amplitude, Latency |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| RMS value |
One time |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/06/2022 |
| 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="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a comparative study in wich 120 participants were taken diabetic patients and healthy subjects. NCV and EMG is conducted to find out the changes in amplitude and latency of diabetic and healthy subjects. NCV is performed on the musculocutaneous and radial nerve and EMG is performed on biceps and triceps muscle. |