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CTRI Number  CTRI/2026/01/101467 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On: 02/07/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study of TolerGen™ capsules for immune health in adults 
Scientific Title of Study   A double blind, randomized, placebo-controlled trial of TolerGen™ capsule to support immune function in adults. 
Trial Acronym  NIL 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
MHC/CT/25-26/022 Version: 2.00; Dated, 20th May 2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ram Mundhe 
Designation  Principal Investigator 
Affiliation  Gunjkar Multispeciality Hospital  
Address  Gunjkar Multispeciality Hospital,OPD No. 1 ,Ground Floor, Plot No 315, Sector No 18,Spine Road,Chinchwad
-
Pune
MAHARASHTRA
411062
India 
Phone  8454859082  
Fax  -  
Email  drrammudhe.gunjkarresearch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharth J Modi  
Designation  Vice President, Scientific Affairs  
Affiliation  PhytoVeda Pvt. Ltd. 
Address  6/10, Jogani Industrial Estate, V.N.Purav Marg, Chunabhatti,
-
Mumbai
MAHARASHTRA
400022
India 
Phone  9309233955  
Fax  -  
Email  sjmodi@phytoveda.in  
 
Details of Contact Person
Public Query  
Name  Dr Siddharth J Modi  
Designation  Vice President, Scientific Affairs  
Affiliation  PhytoVeda Pvt. Ltd. 
Address  6/10, Jogani Industrial Estate, V.N.Purav Marg, Chunabhatti,
-
Mumbai
MAHARASHTRA
400022
India 
Phone  9309233955  
Fax  -  
Email  sjmodi@phytoveda.in  
 
Source of Monetary or Material Support  
Phytoveda Pvt. Ltd., Mumbai,400022, Maharashtra, India. 
 
Primary Sponsor  
Name  PhytoVeda Pvt. Ltd.  
Address  6/10, Jogani Industrial Estate, V.N.Purav Marg, Chunabhatti, Mumbai-400022, India. 
Type of Sponsor  Other [ Private Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  - 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dilip Kadam  Care Superspeciality Hospital  OPD NO.9, C/O WCare Multispeciality Hospital and Daignostics, Behind, Maze College, BAIF Road, Pune Ahilyanagr Road, Wagholi, 412207
Pune
MAHARASHTRA 		 7066115411

dr.dilipkadam12@gmail.com 
Dr Ram Mundhe  Gunjkar Multispeciality Hospital  OPD NO.1 Ground Floor ,Plot No. 315,Sector No. 18, Spine Road, Chinchwad
Pune
MAHARASHTRA 		 8454859082
-
drrammudhe.gunjkarresearch@gmail.com  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee care Superspeciality Hospital   Approved 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adults  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  One 380 mg placebo capsule  Consume orally once a day after breakfast for 90 days.  
Intervention  One 380 mg TolerGenTM Capsule  Consume orally once a day after breakfast for 90 days.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Male or female participants aged between 40 and 70 years both inclusive.
2.Individuals whose blood leukocyte count, a key indicator of immune function, is neither low 3–4×10³ per microLiter nor excessively high 8–10×10³per microLiter.
3.Individuals with IgG levels within the range of 600–1600 mg per dL that is within normal range both inclusive.
4.Individuals who have experienced symptoms of upper respiratory tract infection for example cold, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, at least twice within one year before screening.
5.An immune status questionnaire score of less than 6.
6.Reporting two or more gut health-related symptoms, including bloating, abdominal pain, diarrhea, constipation, or abdominal discomfort.
7.Not currently taking any other immune-boosting health supplements or functional foods.
8.Able and willing to comply with all study procedures and the intervention regimen.
9.Participants willing to participate in clinical trials and who have read, understood and signed the informed consent form.
 
 
ExclusionCriteria 
Details  1.Participants who are unable to take the investigational product orally or as prescribed.
2.Participants over the age of 70 or those with known intolerance or allergy to the investigational product or its components.
3.Individuals with cardiovascular disease, myocardial infarction, angina, heart failure, arrhythmia or a history of pacemaker use.
4.Individuals with liver disease, kidney disease, lung or respiratory disease.
5.Individuals with gastrointestinal diseases Crohn es disease history of gastrointestinal resection, or irritable bowel syndrome.
6.Individuals with thyroid disease or abnormal symptoms.
7.Individuals with autoimmune disease, inflammatory systemic disease, metabolic syndrome or any infectious diseases.
8.Individuals with any type of malignancy, including leukemia.
9.Individuals with neurological or psychiatric disorders for example depression, schizophrenia or a history of psychotherapy.
10.Individuals with diabetes, hypertension, or any musculoskeletal disorders.
11.Individuals who have undergone surgery within the past six months.
12.Females who are pregnant, breastfeeding, within six months postpartum, planning pregnancy, or not using reliable contraception.
13.Individuals engaged in high intensity exercise and willing to continue throughout the study.
14.Individuals who have used immunosuppressants, antibiotics, non-steroidal anti-inflammatory drugs NSAIDs, steroids, or antihistamines within the past 3 months, and have received any vaccination during the same period.
15.Individuals with a history of drug addiction.
16.Individuals who consume alcohol exceeding 30 g per day approx. 3 glasses of beer for men or 20 g per day approx. 2 glasses of beer for women.
17.Participants who have received probiotic or fiber-based treatments within the past 6 months.
18.Individuals who have experienced any severe stressful life events within four weeks before the study.
19.Individuals who have participated in another clinical trial within the past three months.
20.Any other condition, as determined by the investigator, that may render the participant unfit for inclusion in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Changes in NK Cell activity, assessed using the % NK cell activity assay at baseline and Day 90.
2.Changes in immune cell profile, including CD3, CD4, CD4/CD8 ratio, T cells, B cells, and monocytes. 		 1.At baseline and Day 90.
2.At baseline and Day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Evaluate the effects of TolerGen™ supplementation on serum, salivary, and fecal immune biomarkers inflammatory and immunomodulatory markers gastrointestinal symptoms anxiety and sleep quality and overall health status, including cold incidence and related outcomes.
2.Assess safety through clinical laboratory tests and adverse event monitoring, as well as to evaluate participant compliance and tolerability.
3.Evaluate the effects of TolerGenTM capsule supplementation on gastrointestinal symptoms, anxiety levels, sleep quality, and clinical laboratory parameters.  		 1.From Screening to end of the Study.
2.From Screening to end of the study.
3.From Screening to end of the Study. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   28/01/2026 
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="5"
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   Many adults experience reduced immune function due to lifestyle and environmental factors, leading to a mild “hypoimmune” state that increases infection risk but does not qualify as clinical immunodeficiency. Existing medical treatments are not suitable for this population, highlighting the need for safe, non-pharmacological immune support.This randomized, double-blind, placebo-controlled study evaluates whether a nutraceutical combination of Bacopa monnieri, Andrographis paniculata, and Bacillus coagulans ZB1090 (TolerGen™) can improve innate and adaptive immune markers, mucosal immunity, and gut–immune balance, while being safe and well tolerated in adults with hypoimmunity over 90 days. 
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