| CTRI Number |
CTRI/2026/01/100990 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
The impact of taurine intake and mouth rinsing on body functions and athlete performance. |
|
Scientific Title of Study
|
Effect of taurine ingestion and mouth rinsing on physiological and performance variables in 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 |
Dr Deepak Raghav |
| Designation |
Professor |
| Affiliation |
Santosh Medical College, Santosh Deemed to be University |
| Address |
Department of Physiotherapy, Santosh Medical College, Santosh Deemed to be University, Sector 12, Pratap Vihar, Ghaziabad
Ghaziabad UTTAR PRADESH 201009 India |
| Phone |
9868315824 |
| Fax |
|
| Email |
deepak.raghav@santosh.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Vikram Singh Yadav |
| Designation |
PhD Scholar |
| Affiliation |
Santosh Medical College, Santosh Deemed to be University |
| Address |
Department of Physiotherapy, Santosh Medical College, Santosh Deemed to be University, Sector 12, Pratap Vihar, Ghaziabad
Ghaziabad UTTAR PRADESH 201009 India |
| Phone |
7015336462 |
| Fax |
|
| Email |
emailvsy5@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vikram Singh Yadav |
| Designation |
PhD Scholar |
| Affiliation |
Santosh Medical College, Santosh Deemed to be University |
| Address |
Department of Physiotherapy, Santosh Medical College, Santosh Deemed to be University, Sector 12, Pratap Vihar, Ghaziabad
Ghaziabad UTTAR PRADESH 201009 India |
| Phone |
7015336462 |
| Fax |
|
| Email |
emailvsy5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Santosh Medical College, Santosh Deemed to be University, Ghaziabad |
|
|
Primary Sponsor
|
| Name |
Santosh Medical College |
| Address |
Department of Physiotherapy, Santosh Medical College, Santosh Deemed to be University, Sector 12, Pratap Vihar, Ghaziabad-201009, India |
| Type of Sponsor |
Private 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 Deepak Raghav |
Santosh Medical College |
Room No-01, Department of Physiotherapy, Santosh Medical College, Santosh Deemed to be University, Ghaziabad-201009, India Ghaziabad UTTAR PRADESH |
9868315824
deepak.raghav@santosh.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF SANTOSH DEEMED TO BE UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Starch |
During this session subjects will be provided with 250 ml starch solution in plain water for ingestion, which will serve as placebo. After 01 Hr of ingestion of starch solution various study physiological and performance variables will be measured using appropriate tools and tests. Measurements during this test session will act as a baseline data. |
| Intervention |
Taurine |
During this session prior to testing subjects will perform repeated taurine mouth rinsing with prepared 250 ml taurine solution. Taurine mouth rinsing will be for 10 sec with 25 ml solution each time, repeatedly for 10 times. Immediately after taurine mouth rinsing various study physiological and performance variables will be measured using appropriate tools and tests. |
| Intervention |
Taurine |
During this session subjects will ingest prepared 250 ml of taurine solution 01 Hr prior to the testing. After 01 Hr of taurine ingestion, various study physiological and performance variables will be measured using appropriate tools and tests. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
Individuals who are willing to participate.
Athletes with no history of allergy to taurine or protein supplements.
Physically healthy male track & field athletes within the age group of 20 to 30 Yrs.
Individuals who had not consumed creatine, taurine & protein supplements within the past 03 months. |
|
| ExclusionCriteria |
| Details |
Athletes who are consuming NSAIDS or steroidal drugs.
Athletes who had consumed energy drinks in last 07 days.
Athletes who smokes, consumes alcohol and uses ergogenic aids.
Athletes with history of musculoskeletal injuries in last 06 months.
Athletes with known history of respiratory and cardiovascular disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to Exhaustion
Explosive power of lower limb
Explosive power of upper limb
Agility
Balance
Heart rate
Heart rate variability
Blood pressure
Blood lactate levels
Blood glucose levels
Reaction Time |
Immediately after taurine mouth rinsing and 1Hr after taurine and placebo ingestion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="53" Sample Size from India="53"
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)
|
23/01/2026 |
| 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="6" 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
|
Primary purpose of this study is to determine if a single dose of taurine significantly alters the physiological and performance metrics in athletes when compared to placebo, comparing two delivery methods: oral ingestion and mouth rinsing. Further it is hypothesized that both taurine ingestion and mouth rinsing will elicit distinct, effect on physiological and performance related variables in athletes, with the delivery methods potentially influencing the magnitude of these effects. |