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CTRI Number  CTRI/2024/10/075637 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate efficacy and safety of NRAHG001 on ability of heart and lungs to deliver oxygen in healthy subjects.  
Scientific Title of Study   A randomised, prospective, double-blind, placebo-controlled, clinical study to evaluate efficacy and safety of NRAHG001 on cardiorespiratory endurance and fatigue in healthy subjects.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
ECTS/24/006, Version 00, Date: 30 SEP 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Services 
Address  Ethicare Clinical Trial Services (OPC) Private Limited. Block F-1101 to 1110, Prahlad Nagar Trade Center (PNTC), Radio Mirchi Road, Nr. Vastrapur Railway Crossing,

Ahmadabad
GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Services 
Address  Ethicare Clinical Trial Services (OPC) Private Limited. Block F-1101 to 1110, Prahlad Nagar Trade Center (PNTC), Radio Mirchi Road, Nr. Vastrapur Railway Crossing,

Ahmadabad
GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Public Query  
Name  Dr Milan Satia 
Designation  CEO 
Affiliation  Ethicare Clinical Trial Services 
Address  Ethicare Clinical Trial Services (OPC) Private Limited. Block F-1101 to 1110, Prahlad Nagar Trade Center (PNTC), Radio Mirchi Road, Nr. Vastrapur Railway Crossing,

Ahmadabad
GUJARAT
380015
India 
Phone  9825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Source of Monetary or Material Support  
Natural Remedies Private Limited, Plot No. 5B, Veerasandra Industrial Area, 19th K.M. Stone, Hosur Road, Electronic City, Bangalore, Karnataka, India – 560 100  
 
Primary Sponsor  
Name  Natural Remedies Private Limited 
Address  Natural Remedies Private Limited, Plot No. 5B, Veerasandra Industrial Area, 19th K.M. Stone, Hosur Road, Electronic City, Bangalore, Karnataka, India – 560 100  
Type of Sponsor  Other [Animal health 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 Himanshu Prajapati  Prajna Health care Hospital   Room no 205-208, 2nd floor, opd department, Aagum Avenue, Nr. Adani CNG pump, Sabarmati
Ahmadabad
GUJARAT 		 09925075607

drhimanshupcr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cardiorespiratory Endurance and Fatigue 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NRAHG001 capsule  30 mg capsule once daily in the morning either before or after food for 56 days. 
Comparator Agent  Placebo  30 mg capsule once daily in the morning either before or after food for 56 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Healthy, male and/or female adult subjects age between 18 to 45 years old (both inclusive)
2.Subjects doing physical exercise regularly almost 5 days a week for the last two years.
3.Subjects within body mass index (BMI) range of 18.5–24.9 kg/m2.
4.Subjects with Systolic blood pressure (SBP) less than or equal to 130 mm Hg and diastolic blood pressure (DBP) less than or equal to 89 mm Hg.
5.Subjects Ready to abstain from alcohol, caffeine, and vigorous physical activity for 24 h before every study visit.
6. Subjects who can give written informed consent and are willing to participate in the study. 
 
ExclusionCriteria 
Details  1.Subjects with known hypersensitivity to study product.
2.Subjects who have donated blood within one month before the study or have a blood hemoglobin level less than 12.0 g/dl.
3.Subjects with a history of any pulmonary disorder.
4.Known cases of hypertension and diabetes mellitus.
5. SpO2 less than 96%
6.Random blood glucose (RBG) levels greater than or equal to 140 mg/dl.
7.Abnormal thyroid stimulating hormone (TSH) value (less than 0.4 μIU/ml or more than 4.2μIU/ml).
8.Subject with a history of morbid obesity (BMI greater than 40%).
9.Subject with history of any medical condition where exercise is contraindicated.
10.Subjects who are unable to run due to any joint disorder.
11.History of smoking or active smokers using any form of tobacco.
12.Subjects who are currently on diuretics.
13.History/symptoms of any cardiovascular disorder such as coronary artery disease or myocardial infarction.
14.Subjects having clinically significant illnesses of the endocrine, immune, gastrointestinal, hepatobiliary, kidney, urinary, hematological, musculoskeletal system, and/or any inflammatory disorder.
15.History of any significant neurological and psychiatric condition, which may affect the participation and inference of the study endpoints.
16.Participation in other clinical trials in the last 90 days before screening.
17.Subjects who are taking any nutritional supplements, medications, or steroids used to enhance physical performance.
18.History of any orthopedic injury or surgery that incapacitates the subject for exercise.
19.Any planned participation in any sporting event during the study period. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Change in cardiovascular endurance (VO2 max)  Baseline to 56 Days  
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in lactic acid threshold.  Baseline to 56 Days  
2. Changes in blood creatine phosphokinase (CPK)  Baseline to 56 Days  
3. Change in subjective rate of perceived exertion.  Baseline to 56 Days  
4. Change in neuro muscular activation.  Baseline to 56 Days  
5. Changes in fatigue level.   Baseline to 56 Days  
6. Adverse events  Baseline to 56 Days  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) 07/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="7" 
Recruitment Status of Trial (Global)   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  

This study will be conducted to evaluate efficacy and safety of Test product, on cardiorespiratory endurance and fatigue in healthy subjects. Sufficient number of subjects will be enrolled in the study to get 60 evaluable subjects. Subjects who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study. Subject’s visit 1 will be screening visit, Visit 2 will be randomisation visit day 1. Follow up visit 3 will be on 7 ± 2 days, Follow up visit 4 will be on 28 ± 2 days, Follow up visit 5 will be on 54 ± 1 day and end of study visit will be on 56 ± 1 day. Subjects will be screened for the eligibility criteria during screening visit.

The subjects will be randomised in the ratio of 2:1 where they will either receive NRAHG001 30 mg capsule or placebo one daily in morning either before or after food for 56 days. 


 
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