| CTRI Number |
CTRI/2017/05/008566 [Registered on: 16/05/2017] Trial Registered Prospectively |
| Last Modified On: |
16/05/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Scar and Joint Pain treatment using BEST device |
|
Scientific Title of Study
|
Study of BEST device for scar treatment and joint pain relief |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh Bhatia |
| Designation |
Associate Professor |
| Affiliation |
North Eastern Hill University |
| Address |
Room No - S6, Biomedical Engineering Department, North Eastern Hill University, shillong
East Khasi Hills
MEGHALAYA
793022
India |
| Phone |
03642723853 |
| Fax |
|
| Email |
bhatiadinesh@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Bhatia |
| Designation |
Associate Professor |
| Affiliation |
North Eastern Hill University |
| Address |
Room No - S6, Biomedical Engineering Department, North Eastern Hill University, shillong
East Khasi Hills
MEGHALAYA
793022
India |
| Phone |
03642723853 |
| Fax |
|
| Email |
bhatiadinesh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Bhatia |
| Designation |
Associate Professor |
| Affiliation |
North Eastern Hill University |
| Address |
Room No - S6, Biomedical Engineering Department, North Eastern Hill University, shillong
East Khasi Hills
MEGHALAYA
793022
India |
| Phone |
03642723853 |
| Fax |
|
| Email |
bhatiadinesh@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Avazzia Inc
22-A, Jalan Telawi Lima, Bangsar, 59100 Kuala Lumpur, Malaysia |
|
|
Primary Sponsor
|
| Name |
Avazzia Inc |
| Address |
22-A, Jalan Telawi Lima, Bangsar, 59100 Kuala Lumpur, Malaysia |
| Type of Sponsor |
Other [Health & Wellness Device Manufacturing Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dinesh Bhatia |
Department of Biomedical Engineering |
North Eastern Hill University
Umshing, Shillong
East Khasi Hills
MEGHALAYA |
03642723853
bhatiadinesh@rediffmail.com |
| Dr Arun Mukherjee |
UDAAN - for the disabled |
C-27, Dayanand Colony, Lajpat Nagar
South
DELHI |
9811157839
arun@udaan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Human Samples and Participants |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Scars or knee joint pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Patients with scar or joint pain without BEST therapy |
| Intervention |
Interventional Group |
Patients with scar or joint pain before and after BEST therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
i) Subjects with any type of scar OR
ii) Subjects with scar associated with pain
|
|
| ExclusionCriteria |
| Details |
i) Subjects below 18 years of age
ii)Subjects who are pregnant, with implanted pacemaker or any such devices
ii) Subjects with any neurological conditions
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
i) Evaluating the functionality of the device
ii) Relief of knee joint pain
iii) Scar reduction
iv) Publications to highlight the pros and cons of the device |
3 months duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i) Evaluating the functionality of the device
ii) Relief of knee joint pain
iii) Scar reduction
iv) Publications to highlight the pros and cons of the device |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2017 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Studies
and research are ongoing for the appropriate treatment of scar. Electrical
stimulation is one of the approached modality. In the project, this modality
will be used with an additional feature of biofeedback through the use of the
device, Pro-Sport with BEST (Biofeedback Electro-Stimulation Technology)
developed by Avazzia for scar treatment. Several parameters associated with
scar and scar with pain are taken into consideration. The different parameters
changes taking place throughout the course of the treatment are to be studied.
Almost
every individual has a scar on their body. Some may be proud of it while some
would want to get rid of it. However, the present available treatments may or
may not be ineffective to all types of scars. Therefore, for the project, the
population on which the treatment is to be done is kept open i.e., any
individual with any type of scar and even scar associated with pain can take
part in the study. The treatment is done on a regular basis.
|