| CTRI Number |
CTRI/2019/12/022233 [Registered on: 03/12/2019] Trial Registered Prospectively |
| Last Modified On: |
01/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Changes in salivary stress biomarkers (hormones) level during competition in badminton and boxing athletes of Manipur |
|
Scientific Title of Study
|
Changes in salivary stress biomarkers level during competition in athletes of selective sport disciplines of Manipur |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suvam Das Gupta |
| Designation |
PhD Scholar |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur- 795004
Imphal West
MANIPUR
795004
India |
| Phone |
7005676270 |
| Fax |
|
| Email |
suvam.biochem@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suvam Das Gupta |
| Designation |
PhD Scholar |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur- 795004
Imphal West
MANIPUR
795004
India |
| Phone |
7005676270 |
| Fax |
|
| Email |
suvam.biochem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akoijam Joy Singh |
| Designation |
Professor and Head of the Department of PMR RIMS |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur- 795004
Imphal West
MANIPUR
795004
India |
| Phone |
9436026960 |
| Fax |
|
| Email |
joyakoijam2@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur- 795004 |
|
|
Primary Sponsor
|
| Name |
Suvam Das Gupta |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur- 795004 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Akoijam Joy Singh |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur- 795004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suvam Das Gupta |
Regional Institute of Medical Sciences |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur- 795004
Imphal West
MANIPUR |
7005676270
suvam.biochem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy athletes fit to take part in matches or bouts during competition. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Matches or Bouts during competition. |
Changes in normal salivary stress marker levels in athletes due to intervention by matches or bouts during competition for badminton and boxing athletes respectively with a view to measuring alteration in stress, if any. |
| Comparator Agent |
Placebo control |
Athletes not participating in matches or bouts during competition in badminton and boxing respectively. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
1)Elite Athletes of both gender are only included in the study with minimum achieved State or National level medals in their respective sport disciplines viz. boxing and badminton or played International games of their respective sports discipline for the study. 2)Athletes with minimum 5years of advanced training history. 3)Athletes not suffering from any kind genetical disorder. 4)Athletes who didn’t suffered from orthopedic injury in one year. 5)Athletes not suffering from acute illness during the time of testing. 6)Athletes who are willing to participate. 7)Athletes with no previous history of cardiovascular, metabolic or respiratory disease will be selected. 8)In case of boxing athletes, weight category range is 45-60kg to be selected thus to include light weight category boxers as Indian Boxing contingent performance as well as Manipuri athletes performance is much better within this weight category range in recent years for both genders. |
|
| ExclusionCriteria |
| Details |
1)Athletes with pathological findings during physical examination or laboratory testing. 2)Athletes taking artificial supplements or other related medications which may affect selected salivary biomarker concentration for the present study. 3)Athletes suffering from acute Hemolytic crisis. 4)Female athletes with pregnancy. 5)Athletes suffering from acute musculoskeletal injury limiting them from normal physical activity. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand the alteration in stress level, if any, in sportspersons due to intervention by a match or bout among elite athletes of both gender who will be participating in matches or bouts during competition of Badminton and Boxing respectively by using salivary stress biomarkers viz. cortisol, testosterone and immunoglobulin A. |
1year 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measuring of height will be done for proper understanding of physical condition of athletes of both groups. |
1 year 3 months |
| Measuring of body weight will be done for proper understanding of physical condition of athletes of both groups. |
1 year 3 months |
| Measuring of body fat percentage will be done for proper understanding of physical condition of athletes of both groups. |
1 year 3 months |
| Measuring of maximal oxygen uptake viz. VO2 max will be done for proper understanding of physiological condition of athletes of both groups. |
1 year 3 months |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
18/12/2019 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a randomized parallel group, placebo controlled trial to understand the alteration in stress level, if any, in sportspersons due to intervention by a match or bout among elite athletes of both gender who will be participating in matches or bouts during competition of Badminton and Boxing respectively by using salivary stress biomarkers viz. cortisol, testosterone and immunoglobulin A. The study will be conducted on 176 athletes equally taken from both sport disciplines of Manipur, fulfilling, the inclusion and exclusion criteria for 15 months. The primary outcome of the project is to understand the changes in salivary biomarker levels, if any, over five testing session for study group athletes and single testing session for control group athletes. The secondary outcome of the project is to assess the physical and physiological condition of athletes during first testing session for both group of athletes by variables viz. height, weight, body fat percentage and maximum oxygen uptake. And lastly to correlate salivary biomarker level with performance. |