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CTRI Number  CTRI/2025/09/094683 [Registered on: 12/09/2025] Trial Registered Prospectively
Last Modified On: 30/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluate the Effects of PBS-60 in Improving Muscle Strength and Functional Mobility in patients Undergoing total Knee replacement. 
Scientific Title of Study   A Randomized Open-labeled Controlled Study to Evaluate the Effects of PBS-60 in Improving Muscle Strength and Functional Mobility in Subjects Undergoing Total Knee Arthroplasty (TKA) 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajkumar S Amaravati  
Designation  Professor and HOD 
Affiliation  St. Johns Medical College Hospital 
Address  Department of Orthopedic Sarjapur Road Bangalore KARNATAKA 560034 India

Bangalore
KARNATAKA
560034
India 
Phone  9945138739  
Fax    
Email  rajkumar_as@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Mr Hasan Ali Ahmed 
Designation  Director 
Affiliation  Xplora Clinical Research Services Pvt. Ltd 
Address  #252, 13th cross, Wilson garden Bangalore KARNATAKA 560027 India

Bangalore
KARNATAKA
560027
India 
Phone  09886012598  
Fax    
Email  hasan@xplorahealth.com  
 
Details of Contact Person
Public Query  
Name  Mr Hasan Ali Ahmed 
Designation  Director 
Affiliation  Xplora Clinical Research Services Pvt.Ltd 
Address  #252, 13th cross, Wilson garden

Bangalore
KARNATAKA
560027
India 
Phone  09886012598  
Fax    
Email  hasan@xplorahealth.com  
 
Source of Monetary or Material Support  
Amway Global Services India Pvt. Ltd 1st Floor, Unit No. 101-105, Tower A, SAS Tower Medicity, Sector 38, Gurgaon, Haryana 122001  
 
Primary Sponsor  
Name  Amway Global Services India Pvt. Ltd 
Address  1st Floor, Unit No. 101-105, Tower A, SAS Tower Medicity, Sector 38, Gurgaon, Haryana 122001  
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Rajkumar S Amaravati   St. John’s Medical College Hospital  Sarjapur Road, department of Orthopedics, room no 4 ground floor. Bangalore KARNATAKA 560034 India
Bangalore
KARNATAKA 		 9945138739

rajkumar_as@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ST JOHNS MEDICAL COLLEGE HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M235||Chronic instability of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Of Treatment  The comparator arm patient will be on the standard of treatment. 
Intervention  PBS-60  Route-Oral, Dose-30 g/day with water/buttermilk/ milk or mix/sprinkle to food,Frequency-TID,Duration-42 days.  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Male and female volunteers aged between 50-70 years.
2) Individuals scheduled for primary unilateral TKA.
3) Individuals with hematology and serum biochemistry within normal limits
4) Participants who demonstrate willingness to follow study procedures and meet all requirements.
5) Individuals who are prepared to participate in the study and provide informed consent.
 
 
ExclusionCriteria 
Details  1)History of invasive lower extremity surgery within the last 5 years.
2)Known peripheral vascular disease, kidney disease, liver disease, or uncontrolled endocrine disorders. Allergy to soy, wheat or pea products.
3)Body Mass Index (BMI) greater than 18.5 to 29.9 kg /m².
4)Currently adhering to a restrictive weight-loss diet.
5)Known overt cardiovascular or metabolic disorders, such as heart disease or heart failure.
6)Any known/established gastrointestinal surgeries which may interfere with the nutrient absorption
7)Diagnosed with uncontrolled type 2 diabetes or hypertension.
8)Any physical/psychological condition that interferes with performing post-surgery rehabilitation.
9)Active malignancies or other systemic conditions deemed inappropriate for the study by the investigator.
10)Pregnant or breastfeeding women.
11)Individuals with psychiatric disorders that may interfere with participation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the impact of PBS - 60 on improving muscle strength and functional mobility in individuals undergoing TKA.   Day 1 to Day 42 
 
Secondary Outcome  
Outcome  TimePoints 
1) To evaluate the impact of PBS- 60 on pain intensity, and Knee Society Score (KSS) following TKA.
2) Occurrence of adverse events during the study period.
 		 Day 1 to Day 42 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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/ Phase 4 
Date of First Enrollment (India)   23/09/2025 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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 - NO
Brief Summary   Protein and amino acid supplementation is well recognized for its essential role in muscle growth, repair, and strength enhancement ,particularly in the context of orthopedic procedures like total knee arthroplasty (TKA). Proteins, composed of amino acids, are fundamental for muscle protein synthesis (MPS), a process critical for muscle maintenance and growth. Essential amino acids (EAAs) such as leucine, valine, and isoleucine act as key activators of the mTOR pathway, which drives MPS and contributes to increased muscle volume and strength. Numerous studies have highlighted the benefits of protein supplementation in preserving lean muscle mass and enhancing muscle recovery post-surgery, making it especially relevant for individuals undergoing TKA, a surgery often accompanied by a period of reduced mobility and subsequent muscle atrophy for patients recovering from TKA, protein and amino acids not only support muscle repair but also play a significant role in restoring functional mobility .TKA often leads to reduced quadriceps strength and general muscle atrophy, issues that can impede postoperative recovery and affect long-term joint function . Supplementation with protein ,particularly EAAs has been shown to attenuate muscle loss, reduce inflammation, and improve muscle function during recovery.  

The study will be conducted over 42 (6 weeks) days and will follow a randomized, open-labeled, controlled study design. Eligible participants will be randomly assigned at a 1:1 ratio to either the control or test group. Participants will receive either standard of care or standard of care plus PBS-60 for 42 days. The primary objective is to evaluate the impact of PBS-60 on improving muscle strength and functional mobility in individuals undergoing TKA. Secondary objective is to evaluate the impact of PBS-60 on pain intensity, and knee society score (KSS) following TKA. Occurrence of adverse events during the study period. The safety assessments are vital signs, physical examination, laboratory assessment and adverse events. Efficacy assessments are visual analogue scale (VAS) for pain intensity, The 2011 knee society scoring system, WHO-5QOL questionnaire, Brief Resilience Scale (BRS) questionnaire, Clinical assessment questionnaire, the western ontario and mcmaster Universities osteoarthritis index (WOMAC) and assessment of functional mobility.
 
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