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CTRI Number  CTRI/2021/07/035206 [Registered on: 28/07/2021] Trial Registered Prospectively
Last Modified On: 08/01/2022
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 assess the efficacy and safety of an Immunostimulant supplement on the immunity of healthy human subjects 
Scientific Title of Study   A prospective, randomized, double-blind, multiple dose, parallel, placebo-controlled, clinical interventional study to evaluate the efficacy and safety of an Immunostimulant supplement on the immunity of healthy human subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Alexander  
Designation  Medical Monitor  
Affiliation  G7 Synergon Private Limited  
Address  No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India

Bangalore
KARNATAKA
560092
India 
Phone  9916252529  
Fax    
Email  ajay.alexander@g7synergon.in  
 
Details of Contact Person
Scientific Query  
Name  Dr D Sathish Kumar  
Designation  Managing Director  
Affiliation  G7 Synergon Private Limited  
Address  No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India

Bangalore
KARNATAKA
560092
India 
Phone  9677014651  
Fax    
Email  sathishkumar@g7synergon.in  
 
Details of Contact Person
Public Query  
Name  Dr D Sathish Kumar  
Designation  Managing Director  
Affiliation  G7 Synergon Private Limited  
Address  No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India


KARNATAKA
560092
India 
Phone  9677014651  
Fax    
Email  sathishkumar@g7synergon.in  
 
Source of Monetary or Material Support  
OmniActive Health Technologies,Phoenix House T8 A Wing 462 Senapati Bapat Marg Lower Parel Mumbai 400013  
 
Primary Sponsor  
Name  OmniActive Health Technologies  
Address  OmniActive Health Technologies,Phoenix House T8 A Wing 462 Senapati Bapat Marg Lower Parel Mumbai 400013  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Belliappa C M A  Telerad RxDx Healthcare Pvt. Ltd  Ground Floor, Plot No. 7G, Kundalahalli Main Rd, Opp. Graphite India Whitefield, Bengaluru Urban Karnataka - 560048, India
Bangalore
KARNATAKA 		 9880673579

belligp_2000@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Telerad RxDx Healthcare Pvt. Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Immunostimulant supplement on the immunity of healthy human subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  OAHT Immune Boost Tablets  Single tablet to be taken preferably in the morning after breakfast for 2 months. 
Comparator Agent  OAHT Immune Boost Tablets (Placebo)  Single tablet to be taken preferably in the morning after breakfast for 2 months. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Healthy male or non-pregnant, non-lactating female human subjects between age of ≥ 30 and ≤ 70 years who frequently suffers from cold, flu, and fever.
2. Subjects who smoke and willing to abstain from smoking and consuming tobacco throughout the study duration.
3. Subjects who consume alcohol and willing to abstain from consuming alcohol throughout the study duration.
4. Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation at baseline measurement.
5. Subjects willing to avoid anti-inflammatory/immunostimulant/ immunosuppressant medications during the study period.
6. Female subjects of childbearing potential practicing an approved method of contraception and willing to continue its use throughout the study duration or female subjects of non-childbearing potential.
7. Subjects willing to provide written consent.
8. Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return at the appropriate scheduled visits, comply with therapy prohibitions, and be able to complete the study.
 
 
ExclusionCriteria 
Details  1. History or evidence of hypersensitivity to any ingredient from the formula or its metabolites.
2. Subjects with clinically significant disease(s) or disorder(s) in the opinion of the Investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in the study.
3. History of hypo and hyperthyroidism.
4. Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding, unintentional weight loss, anemia, dysphagia, or abdominal mass.
5. History of milk, gluten allergies, or other known food intolerances and/or any food allergies.
6. History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rash.
7. Subjects taking ace-inhibitors, cholesterol-lowering medications.
8. History of difficulty with donating blood or difficulty in the accessibility of veins.
9. Receipt of any prescription drugs or over-the-counter drugs (e.g.: cough and cold preparations, antacid preparations and natural products used for therapeutic benefits) within 30 days before screening.
10. Current use of an immunostimulant/immunosuppressant supplement.
11. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
12. Female subjects with positive Urine Pregnancy Test at the screening.
13. Subjects who have been treated with any investigational drug or investigational device within 3 months before study entry.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
• Mean change from baseline on immunity as determined by laboratory parameters
• Mean change from baseline on stress as determined by Perceived Stress Scale
• Mean change from baseline on sleep as determined by PSQI
 		 • Baseline (Visit 1), 4 weeks (Visit 2) and 8 weeks (Visit 3)
• Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks)
• Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks)  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/08/2021 
Date of Study Completion (India) 13/10/2021 
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   Nil 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  as per the journal standard

  6. For how long will this data be available start date provided 01-12-2021 and end date provided 03-03-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   A prospective, randomized, double-blind, multiple dose, parallel, placebo-controlled, clinical interventional study, proof of concept study on healthy human subjects.Single tablet to be taken preferably in the morning after breakfast for 2 months.Approximately 30 healthy male or non-pregnant, non-lactating female subjects age between ≥ 30 and ≤ 70 years who frequently suffer from cold, flu, and fever shall be enrolled into the study.  
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