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CTRI Number  CTRI/2025/06/088564 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 05/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A to assess the effect of ProGenr8 (Probiotic Supplement) on Immune Health in Teachers prone to Upper Respiratory Tract Infection (URTI) 
Scientific Title of Study   A Randomized, Double-blind, Placebo-controlled, Parallel Clinical study to assess the effect of ProGenr8 (Probiotic Supplement) on Immune Health in Teachers prone to Upper Respiratory Tract Infection (URTI) 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
SB/240701/IP/URTI VERSION: 1.0 DATE: 28th January, 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Vaze 
Designation  Sr.Manager-Clinical Development 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri WestMumbai Mumbai (Suburban) Mumbai (Suburban) MAHARASHTRA Mumbai (Suburban)

Mumbai
MAHARASHTRA
400053
India 
Phone  8655670964  
Fax    
Email  sanjay.v@vediclifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Vaze 
Designation  Sr.Manager-Clinical Development 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri WestMumbai Mumbai (Suburban) Mumbai (Suburban) MAHARASHTRA Mumbai (Suburban)

Mumbai
MAHARASHTRA
400053
India 
Phone  8655670964  
Fax    
Email  sanjay.v@vediclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonal Raote 
Designation  Manager-Clinical Operations 
Affiliation  Vedic Lifesciences Pvt Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri WestMumbai Mumbai (Suburban) Mumbai (Suburban) MAHARASHTRA Mumbai (Suburban)

Mumbai
MAHARASHTRA
400053
India 
Phone  7738373850  
Fax    
Email  sonal.raote@vediclifesciences.com  
 
Source of Monetary or Material Support  
Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai –400053, Maharashtra, India 
 
Primary Sponsor  
Name  Vedic Lifesciences Pvt. Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri WestMumbai Mumbai (Suburban) MAHARASHTRA 400053 India 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasad Nikam  Ayush Hospital  Ayush Hospital, Surya Arcade, 2nd Floor, Opp Nimani Bus Stand, Panchavati, Nashik, 422003
Nashik
MAHARASHTRA 		 9922999002

drprasadnresearch@gmail.com 
Dr Rupali Gulavani  ENT and Vertigo Clinic  Veerbhadra Nagar, Pune-411045, Maharashtra, India
Pune
MAHARASHTRA 		 9923108585

drrupalivg@gmail.com 
Dr Madhumati Varma  Jaipur National University Institute for Medical Sciences and Research Centre  Jaipur National University Institute for Medical Sciences and Research Centre Near New RTO office, Jagatpura, Jaipur-302017
Jaipur
RAJASTHAN 		 9257036514

researchjun@gmail.com 
Dr Manoj Kumar Pal  Janta Hospital & Maternity Centre  Near Water Head Tank, Amara-Akhari Bypass, Chunar Road, Varanasi - 221011, Uttar Pradesh, India.
Varanasi
UTTAR PRADESH 		 9198677778

manojpalvns@gmail.com 
DrDevesh Rajani   Medical Care Centre & hospital  09, Laxmi Complex, Kanpur - Lucknow Rd, Ram Nagar, Alambagh, Lucknow, Uttar Pradesh 226005
Varanasi
UTTAR PRADESH 		 9415888888

deveshrajani@gmail.com 
Dr Amar Raykantiwar  Silver Birch Multispeciality Hospital  Silver Birch Multispeciality Hospital, Sr. No. 61, A/9/201/11, plot no.4 , OPD construction, Narhe- Dhayari road Pune maharashtra-411041
Pune
MAHARASHTRA 		 8451941050

dr.amarray26@gmail.com 
Dr Chandresh Agarwal  Subharti Medical College, Subharti Puram  Subharti Medical College, Subharti Puram, NH-58, Delhi, Haridwar Bypass Road, Meerut-250005.
Meerut
UTTAR PRADESH 		 9873200745

Chandresh02@gmail.com 
Dr Maheshwar Shitole  Sunrise Multispeciality Hospital  Sunrise Multispeciality Hospital C.S.NO 517 A/plot no 70, near Hotel K tree, E Ward, Shivaji Park, Kolhapur, Maharashtra 416001
Kolhapur
MAHARASHTRA 		 8623811740

drshitole.crd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Ford Hospital and Ethics Commitee   Approved 
IEC Medical care centre & Hospital  Submittted/Under Review 
Institutional Ethics Committee Subharti Medical College & Hospital  Submittted/Under Review 
Institutional Ethics Committee, Jaipur National University Institute for Medical Sciences & Research Centre  Submittted/Under Review 
Leelavat Ethics Committee  Submittted/Under Review 
Royal Pune Independent Ethics Committee   Submittted/Under Review 
Royal Pune Independent Ethics Committee  Submittted/Under Review 
Sunrise Ethics Committtee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Microcrystalline cellulose, calcium carbonate, Mg Stearate, Sylysia  one capsule once a day with/before breakfast for 120 days 
Intervention  Propionibacterium freudenreichii P.UF1  One capsule once a day with/before breakfast for 120 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Individuals ready to give voluntary, written informed consent to participate in the study.
2. Male and female teachers aged between 18 to 50 years’ (both values included) with moderate physical activity level as per International Physical Activity Questionnaire – Short Form (IPAQ - SF).
3. Individuals with body mass index (BMI) between 22 kg per m2 to 32.0 kg per m2
4. High susceptibility to URTIs at least once every three months for last 1 year (at least 4 to 6 episodes in a year).
5.Individuals who have active URTI episode at screening defined as “those having a score of less than equal to 5 for at least 2 symptoms out of runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough or head congestion on the WURSS-21”.
6. Commitment to adhere to routine diet and physical activity.
7. Willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, Echinacea, fish oil, vitamin E, etc.) at least 1 one month prior to screening.
8. Willing to discontinue sleep medications at least 1 month prior to screening and during the entire study duration.
9. Individuals willing to complete all study-related and clinical study visits as per the protocol. 
 
ExclusionCriteria 
Details  1.Individuals with a history of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc
2. Individuals taking prebiotics, probiotics, synbiotics or post-biotics supplements 1 month prior to screening.
3. Individuals with known sensitivity to the investigational products or any excipients of the product.
4. Individuals with any clinically significant abnormalities of the upper respiratory tract (such as stridor, laryngomalacia, etc.).
5. Individuals suffering from lower respiratory tract infection (LRTI) of any origin.
6. Any individual not willing to follow the abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, and vapor rub, etc.
7.Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose less than equal to 126 mg per dL.
8.Individuals with uncontrolled hypertension on medication and with systolic blood pressure less than 140 and or diastolic blood pressure less than equal to 90 mmHg.
9. Individuals who are unable to abstain from herbal or dietary supplements for URTI throughout the study period.
10. Vaccination against influenza or swine flu within 90 days prior to screening.
11. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, NSAIDs, or other medications that are expected to alleviate cold symptoms within two weeks prior to screening.
12. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study’s end points.
13. Participation in other clinical trials in last 90 days prior to screening
14. Individuals with substance abuse problems (within 2 years) defined as: a) Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence. b) High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men.
15. Individuals who have clinically significant following severe illness
16. Females who are pregnant/planning to be pregnant or lactating or taking any oral contraceptives.
17. Any condition that could, in the opinion of the investigator, preclude the individual’s ability to successfully and safely complete the study or that may confound study outcomes 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of the 120 days’ administration of ProGenr8™ on % population having one or more episodes of URTI during the study duration as assessed by Wisconsin Upper Respiratory Symptom Survey Questionnaire – 21 (WURSS – 21) as compared to baseline and placebo.
 		 Throughout the study during episodes
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of ProGenr8™ in comparison to baseline and placebo on:
-Severity of the URTI episodes as assessed by WURSS – 21.
-Number of URTI episodes
-Mean duration of URTI episodes as assessed by the time taken for resolution of the symptoms.
-Number of missed work days due to URTI as assessed by e-diary records and attendance records.
-Work productivity as assessed by WPAI.
-Quality of life as assessed by WURSS-QoL. 		 Throughout the study during episodes 
To assess the effect of ProGenr8™ in comparison to baseline and placebo on:
-Satiety as assessed by Hunger Satiety Scale (HSS).
- Mood as assessed by Brief Mood Introspection Scale (BMIS).
-State anxiety and Trait anxiety as assessed by the State-Trait Anxiety Inventory (STAI).
-Sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI).
-Working memory as assessed by Counting span task.
-Stool consistency as assessed by Bristol Stool Form Scale (BSFS).
-Gastrointestinal symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS).
-Change in body weight assessed by weighing scale.
-Anthropometric assessment as assessed by waist, hip, thigh circumference and waist to height ratio. 		 Day 0, Day 30, Day 60, Day 90, Day 120] 
To assess the effect of ProGenr8™ in comparison to baseline and placebo on
-Body composition (Fat tissue, lean mass, fat free mass) as assessed by Dual Energy X-ray Absorptiometry (DEXA).
-Gut microbiome analysis as assessed by Next Generation Sequencing (NGS).
 		 Day 0 and Day 120 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   08/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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   The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical study designed to assess the effects of IP on immune health in teachers prone to URTI. Approximately 179 individuals aged between 18 and 50 years will be screened. Considering a screen failure of 20%, approximately 144 individuals will be randomized in a ratio of 1:1 to receive either the active or placebo. The study will have at least 100 completed participants i.e. 50 participants in each study arm after accounting for a dropout/withdrawal rate of 30% at the end of the study. The intervention and follow-up duration for all the study participants will be 120 days. 
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