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CTRI Number  CTRI/2024/03/063586 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Trial on Muscle strength in healthy male subjects. 
Scientific Title of Study   A Randomized, two armed, double blind, placebo controlled Clinical Trial to evaluate the efficacy and safety of NS2128E03 in the improvement of Muscle strength and endurance in healthy male subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/NSMS/2023 Version 1.0 Dated 14th December 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi  
Designation  C E O 
Affiliation  Radiant Research Services Pvt Ltd  
Address  Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, Karnataka, INDIA

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sameer K Akolkar 
Designation  Head-R&D 
Affiliation  Natural & Essential Oils Pvt Ltd 
Address  No.74/2B, Manandavadi Road, HD Kote Rd, Sriramapura, Mysuru, Karnataka

Bangalore
KARNATAKA
570008
India 
Phone  9398526599  
Fax    
Email  sameer@nesso.com  
 
Details of Contact Person
Public Query  
Name  Dr Sameer K Akolkar 
Designation  Head-R&D 
Affiliation  Natural & Essential Oils Pvt Ltd 
Address  No.74/2B, Manandavadi Road, HD Kote Rd, Sriramapura, Mysuru, Karnataka


KARNATAKA
570008
India 
Phone  9398526599  
Fax    
Email  sameer@nesso.com  
 
Source of Monetary or Material Support  
Natural & Essential Oils Pvt Ltd No.74/2B, Manandavadi Road, HD Kote Rd, Sriramapura, Mysuru, Karnataka 570008  
 
Primary Sponsor  
Name  Natural & Essential Oils Pvt Ltd 
Address  No.74/2B, Manandavadi Road, HD Kote Rd, Sriramapura, Mysuru, Karnataka 570008 
Type of Sponsor  Other [Nutraceutical and dietary supplement company] 
 
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 Varadarajulu Reginald   Medstar Speciality Hospital  641/17, Medstar Speciality Hospital Ground floor room no: 2,Kodigehalli Main Rd, Sahakar Nagar, Sanjeevini Nagar, Bangalore, Karnataka – 560092, India
Bangalore
KARNATAKA 		 8248599949

varadarajuludr.medstar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medstar Speciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Male subjects who are gym going  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NS2128E03 (Natural Herbal blend of Tamarindus indica seeds extract and Moringa oleifera leaves extract.)  Dose: 500mg per day to be consumed in morning 30-45 minutes before exercise. Dosage form: Capsules Route : Orally Duration: 60days  
Comparator Agent  Placebo  Dose: 500mg per day to be consumed in morning 30-45 minutes before exercise. Dosage form: Capsules Route : Orally Duration: 60days 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. Male volunteers between the age group of 25-45 years.
2. Subjects who are familiar with weight training and had atleast 4 months of experience in the gym (defined as 4 times per week for minimum of 3 to 4 hours per week).
3. Subjects who are willing and able to understand and follow the protocol and provide informed consent.
4. Agree not to use any medication (prescription and over the counter), including vitamins and minerals, and any alternative medications during the course of this study.
5. Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range 
 
ExclusionCriteria 
Details  1. Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological)
2. Patients with pre-existing severe systemic disease necessitating long-term medication.
3. Subjects suffering from any serious medical or surgical illness.
4. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.
5. Any neurological (congenital or acquired), musculoskeletal, joint health conditions, psychological, vascular or systemic disorder which could affect any of the efficacy assessments.
6. Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate), ECG hematology, serum chemistry.
7. More than 4 short courses of oral corticosteroids within the year preceding the screening visit, or any oral corticosteroids in the preceding 4 weeks.
8. Use of Astemizole, Nedocromil, Cromolyn, long acting β agonists, Ketotifen, Theophylline or testosterone within 4 weeks before.
9. Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1. The change from baseline muscle strength, assessed by one-repetition maximum (1-RM) bench and leg presses, and handgrip strength (Dynamometer).
2. Cable pull-down repetitions, time to exhaustion on a treadmill, mid-upper arm circumference (MUAC) and free and total testosterone levels in serum. 		 Day 0, Day 15,Day 30 and Day 60 
 
Secondary Outcome  
Outcome  TimePoints 
1. safety of NS2128E03 and consumer acceptance through feedback questionnaires.
2. Adverse events (AEs).
3. Abnormal findings in vital signs and medical interviews.
4. Abnormal changes in the hematology/blood chemistry test results.
 		 Day 0, Day 15,Day 30 and Day 60  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   11/03/2024 
Date of Study Completion (India) 30/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
NS2128E03 is a blend of Tamarindus indica seeds extract and Moringa oleifera leaves extract.Both these extracts have been achieved using regulatory approved safe solvents, ethanol and water.Tamaridus indica and Moringa oleifera are used in food preparations and consumed in various countries on regular basis. Based on the In-vivo efficacy study, NESSO desires to conduct a Human efficacy study (Clinical trial) to evaluate the effect of this blend on improving exercise
efficiency and Testosterone levels.

Here, based on the In-vitro and In-vivo efficacy studies, NESSO has developed a synergistic combination of Tamarind seed extract and Moringa leaf extract to enhance the Testosterone levels in individuals. This will boost the exercise efficiency in subjects leading to better muscle performance and endurance.
 
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