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CTRI Number  CTRI/2024/02/063107 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 21/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   The ability of essential amino acids to boost muscle mass in people who suffer from muscle loss. 
Scientific Title of Study   To evaluate the effectiveness of essential amino acids in primary sarcopenia 
Trial Acronym  RACE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tufail Muzaffar 
Designation  Assistant Professor 
Affiliation  Sher-i-Kashmir Institute of Medical Sciences 
Address  Department of Physical Medicine and Rehabilitation, SKIMS, Soura
Soura
Srinagar
JAMMU & KASHMIR
190011
India 
Phone  9419418912  
Fax    
Email  tufailmuzaffar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tufail Muzaffar 
Designation  Assistant Professor 
Affiliation  Sher-i-Kashmir Institute of Medical Sciences 
Address  Department of Physical Medicine and Rehabilitation, SKIMS, Soura
Soura

JAMMU & KASHMIR
190011
India 
Phone  9419418912  
Fax    
Email  tufailmuzaffar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tufail Muzaffar 
Designation  Assistant Professor 
Affiliation  Sher-i-Kashmir Institute of Medical Sciences 
Address  Department of Physical Medicine and Rehabilitation, SKIMS, Soura
Soura

JAMMU & KASHMIR
190011
India 
Phone  9419418912  
Fax    
Email  tufailmuzaffar@gmail.com  
 
Source of Monetary or Material Support  
SKIMS Srinagar 
 
Primary Sponsor  
Name  pimary investigator 
Address  Department of Physical Medicine and Rehabilitation, SKIMS, Soura 
Type of Sponsor  Other [pimary investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tufail Muzaffar  Sher-i-Kashmir Institute of Medical Sciences  Department of Physical Medicine and Rehabilitation, SKIMS, Soura, Srinagar
Srinagar
JAMMU & KASHMIR 		 9419418912

tufailmuzaffar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sher-i-Kashmir Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Essential Amino Acid(EAA)  Essential Amino Acid(EAA)( L Lysine 378mg, L Leucine 342 mg, L Arginine 315 mg, Valine 302mg, L Methionine 302mg, Iso Leucine 302 mg, L Phenylalanine 203 mg, L Threonine 203 mg, L Histidine 158mg, L Tryptophan 104 mg, Vitamin D3 600 IU) stick 4 grams twice daily for 4 weeks per oral 
Comparator Agent  PLACEBO  PLACEBO (Maltodextrin 400mg, Malic Acid200mg, Guava Powder Flavour500mg, Citric acid anhydrous 400mg, Acusulfame potassium 300mg, Beet root Powder 800mg , Collodial Sillicon Dioxide 600mg, Magnesium Sterate 800) sticks 4 grams twice daily for 4 weeks per oral 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Healthy individuals 50 years and above age
who fall below the cutoff Ishii sarcopenia score. 
 
ExclusionCriteria 
Details  severe cognitive impairment, poor controlled psychiatric disease, acute infections or known cancer, rheumatoid arthritis, osteonecrosis of the knee, post-traumatic OA, severe hepatic or renal disease, or other condition which could affect the metabolism of nutrients such as cancer, diabetes mellitus and obesity. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Ishii Score
Muscle strength on DAVID 		 0, 4 and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Deterioration of muscle strength  6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   21/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/03/2024 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  hard copy from the department of PMR SKIMS Soura

  6. For how long will this data be available start date provided 21-04-2025 and end date provided 21-04-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This is a prospective, randomised placebo-controlled trial, double-blinded with a convenience sampling of the patients visiting our department in Sher-e-Kashmir Institute of Medical Sciences, Srinagar who are in the age group of 50 to 90 years (sample size of 50; 25 in each group (intervention arm and control arm)) comparing the efficacy of essential amino acid sticks (4gm of EAA sticks containing L Lysine 378mg, L Leucine 342 mg, L Arginine 315 mg, Valine 302mg, L Methionine 302mg, Iso Leucine 302 mg, L Phenylalanine 203 mg, L Threonine 203 mg, L Histidine 158mg, L Tryptophan 104 mg, Vitamin D3 600 IU BD for 4 weeks) and in the control arm (4gm of placebo stick containing Maltodextrin, Malic Acid,Guava Powder Flavour, Citric acid anhydrous, Acusulfame potassium, Beet root Powder, Collodial Sillicon Dioxide, Magnesium Sterate BD for 4 weeks) on individuals who fall below the cutoff Ishii sarcopenia score. The primary outcome measures will be the Ishii score and Isometric Quadriceps muscle strength on the DAVID machine at 0, 4 and 12 weeks.

 
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