FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068758 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to evaluate the the Anabolic Efficacy of PRP-02 in Healthy Human Adults.  
Scientific Title of Study   A Prospective, Single Arm, Open-label Clinical Study to Evaluate the Anabolic Efficacy of PRP-02 in Healthy Adults. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
AMW/ CTP/ABS/13-2024 Version 1.0 dated 18 Jan 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshith C S 
Designation  Assistant Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Deaprtment of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9741073960  
Fax    
Email  drharshithcs.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt.Ltd 
Address  Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt.Ltd 
Address  Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Amway Global Services India (AGSI) 1st Floor, Unit No. 101-105, Tower A, SAS Tower Medicity, Sector 38, Gurgaon, Haryana 122001  
 
Primary Sponsor  
Name  Amway Global Services India (AGSI)  
Address  1st Floor, Unit No. 101-105, Tower A, SAS Tower Medicity, Sector 38, Gurgaon, Haryana 122001 
Type of Sponsor  Other [Manufacturer of natural plant based formulations] 
 
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 Harshith C S  BGS Global Institute of Medical Sciences  Room No.3, Department of General Medicine, BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 9741073960

drharshithcs.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal Hematological and Biochemical Parameters 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  PRP-02  2 scoops mixed with buttermilk or skimmed milk or water and administered 10 minutes before all the 3 major meals 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Healthy vegetarian, adult male and female subjects, aged 18 to 45 years (both inclusive)
2.Subjects who are not taking any supplements with anabolic agents (muscle building) and/or protein powder in the past 4 weeks.
3.Subjects who have a habitual protein intake of less than or equal to 0.8 g/kg/day based on a food frequency questionnaire
4.Subjects with Body mass index (BMI) between 19-24.9 (kg/m2) with a stable weight over the past 3 months
5.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test at screening
6.Subjects willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study.
7.Subjects who are able to understand the benefits and risks of the study protocol, follow the protocol and come for follow-up visits.
8.Must be willing and able to give informed consent and comply with the study procedures.
 
 
ExclusionCriteria 
Details  1.Subjects diagnosed with Type 1 and 2 diabetes mellitus
2.Subjects currently on medication/ HRT (Hormone Replacement Therapy)
3.Subjects with musculoskeletal disorders that make it difficult to exercise
4.Women in the reproductive age group not willing to use standard contraceptive measures.
5.Subjects with history of
oEndocrine hypothalamic- pituitary disease, women with PCOS, adrenal disorder, hypothyroidism
oChronic kidney disease,
oRenal stones,
oLiver dysfunction (with elevated enzyme levels),
oEating disorders,
oChronic gastrointestinal disorders
oInflammatory bowel disease (IBD) or celiac disease,
oMetabolic disorders like hypertension, cardiovascular diseases - that might impair the outcomes
oMalignancy which is currently active or in remission for less than five years after last treatment
6.Subjects with unstable weight (± 5 % fluctuation in their body weight for past 3 months at study entry)
7.Subjects who have undergone a surgical procedure within 1 month of signing informed consent and currently participating or has participated in a study with an investigational drug or device
8.Subjects who maybe allergic to soy or wheat or pea.
9.Known HIV or Hepatitis B positive or any other immuno-compromised state
10.Pregnant and lactating women
11.Currently participating or having participated in another clinical trial during the last 30 days prior to screening or are likely to simultaneously participate in another clinical study.
12.Subjects who are doubtful to comply with study procedures for mental, psychological or social reasons.
13.Subjects who are not willing to sign the informed consent and follow the study protocol.
14.Any additional condition(s) that in the Investigators opinion that may interfere with subject treatment, assessment or compliance with the protocol and would warrant exclusion from the study or prevent the subject from completing the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in muscle strength including handgrip strength, Pectoral strength and Quadriceps strength  Baseline, Day 14, Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Biomarkers and Overall Safety  Baseline, Day 14, Day 28 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   21/06/2024 
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="0"
Months="3"
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   This is a clinical study to evaluate the efficacy of PRP-02. Subjects meeting all inclusion and exclusion criteria will be enrolled in the study after signing a written informed consent.   The study will be conducted in 6 visits (4 onsite visits and 2 telephonic follow-ups) over 28 days. The efficacy assessments include changes in muscle strength, body composition, and skin fold thickness. Blood, urine, and fecal samples will be collected for safety and efficacy assessments. The overall safety and adverse events will be monitored throughout the study period. 
Close