| CTRI Number |
CTRI/2024/08/072233 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
investigating ergogenic effects of citrulline malate on performance of track and field athletes. |
|
Scientific Title of Study
|
A study to investigate the acute effects of citrulline malate on performance and physiological variables in track and field athletes. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudhanshu |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Address |
PG clinic, E-block, Department of Physiotherapy, College of Physiotherapy, PGIMS, Rohtak, Haryana 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
8168646596 |
| Fax |
|
| Email |
sud.tawar.sushanshu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Singh Yadav |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Address |
Faculty Room, E-block, Department of Physiotherapy, College of Physiotherapy, PGIMS, Rohtak, Haryana 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
9466441234 |
| Fax |
|
| Email |
vikramsinghyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikran Singh Yadav |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Address |
Faculty Room, E-block, Department of Physiotherapy, College of Physiotherapy, PGIMS, Rohtak, Haryana 124001 India
Rohtak
HARYANA
124001
India |
| Phone |
9466441234 |
| Fax |
|
| Email |
vikramsinghyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001 India
|
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak |
| Address |
College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001 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 Vikram Singh Yadav |
Pandit Bhagwat Dayal Sharma University of Health Sciences, Rohtak, Haryana, India, 124001 |
College of Physiotherapy, PG Clinic, E-block, ground floor, Emergency building, PGIMS Rohtak, Haryana, 124001, India
Rohtak
HARYANA |
9466441234
vikramsinghyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee College of Physiotherapy, Pandit B.D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sports Person |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Citrulline malate administration |
Visit 1 will consist of measuring power, fatigue index, agility, explosive strength of lower limb, peak torque of lower limb as baseline parameters.
Visit 2, 250mg/kg of citrulline malate in 300 ml of water will be given to athletes and the mentioned parameter will be measured along. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Athletes within the age group of 18-30 years will be included in study.
Athlete should be free from knee/hip injury past 6 months.
Athlete who participated in competitions at least district levels or with minimum two years of training. |
|
| ExclusionCriteria |
| Details |
Person who smokes or consume alcohol and uses ergogenic aids.
Athlete having hip/knee injury in past 6 months.
Sports person who is not willing to participate in study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Power
Fatigue index
Agility
Explosive strength of lower limb
Peak torque lower limb
Heart rate
Blood pressure
Respiratory rate
|
At base line (day 1)
Citrulline malate administration (day 2)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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 Yet Recruiting |
| 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
|
The study aims to investigate the effects of citrulline malate supplementation on physical and physiological performances of 40 track and field athletes. Visit1 will consist of measuring power, fatigue index, agility, explosive strength of lower limb, peak torque of lower limb as baseline parameters. Visit2, 250mg/kg of citrulline malate in 300ml of water will be given to athletes and the mentioned parameter will be noted again. After measurement, data will be analyzed and appropriate software will be used to compare pre-post interventions within groups. |