FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093139 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Turmeric Spice Herbal Tea Study on Overall Immunity 
Scientific Title of Study   Effect of Turmeric Spice Herbal Tea on Overall Immunity in Healthy Adults: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MC/TSHT/25-007 Version 1.0 Dated 18 Jun 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushavan Sinha 
Designation  Head - Innovations & Product 
Affiliation  Luxmi Tea Co Private Limited 
Address  Luxmi Tea Co Private Limited 17 RN Mukherjee Road Kolkata 700001 West Bengal, India

Kolkata
WEST BENGAL
700001
India 
Phone  9609978633  
Fax    
Email  sushavan@luxmigroup.in  
 
Details of Contact Person
Scientific Query  
Name  Sushavan Sinha 
Designation  Head - Innovations & Product 
Affiliation  Luxmi Tea Co Private Limited 
Address  Luxmi Tea Co Private Limited 17 RN Mukherjee Road Kolkata 700001 West Bengal, India


WEST BENGAL
700001
India 
Phone  9609978633  
Fax    
Email  sushavan@luxmigroup.in  
 
Details of Contact Person
Public Query  
Name  Sushavan Sinha 
Designation  Head - Innovations & Product 
Affiliation  Luxmi Tea Co Private Limited 
Address  Luxmi Tea Co Private Limited 17 RN Mukherjee Road Kolkata 700001 West Bengal, India


WEST BENGAL
700001
India 
Phone  9609978633  
Fax    
Email  sushavan@luxmigroup.in  
 
Source of Monetary or Material Support  
Luxmi Tea Co Private Limited 17 RN Mukherjee Road Kolkata 700001 West Bengal, India  
 
Primary Sponsor  
Name  Luxmi Tea Co Private Limited 
Address  Luxmi Tea Co Private Limited 17 RN Mukherjee Road Kolkata 700001 West Bengal, India  
Type of Sponsor  Other [Tea Industry] 
 
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 Asis Mitra  ODM Clinic  ODM Clinic , 32/1A KP Roy Lane , Sahidnagar, Kolkata- 700031
Kolkata
WEST BENGAL 		 9831671525

asis.mitra10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Clinic NOC Letter  No Objection Certificate 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Overall immunity 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal tea (Assam Black Tea, Grade - Orthodox leaves)  Normal tea (Assam Black Tea, Grade - Orthodox leaves): Serving Size- 2g (tea bag) in 150 ml hot water, 3 mins brewing at about to boil water. Recommended consumption: One cup (150 ml) of Normal Tea twice daily for 8 weeks. Duration: 8 weeks 
Intervention  Turmeric Spice Herbal Tea  Turmeric Spice Herbal Tea: Serving Size- 2g (tea bag) in 150 ml hot water, 5 mins brewing at about to boil water. Recommended consumption: One cup (150 ml) of Turmeric Spice Herbal Tea twice daily for 8 weeks. Duration: 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Healthy adults, both males and females, aged 18 to 65 years, both inclusive, at the time of screening.
Willing and able to provide written informed consent before any study related procedures. This ensures that participants understand the study purpose, procedures, risks, and benefits and that their participation is voluntary.
Participants must be daily tea taker,
Participants willing and able to comply with all study procedures, including daily consumption of the assigned tea Turmeric Spice Herbal Tea or Normal tea prepared as per direction provided and continuing for the duration of the study,
Participants willing to attend scheduled study visits, and completing all required questionnaires.
Access to a telephone and the ability to be contacted by study personnel
Agreement to maintain a stable diet throughout the study period Day 0 to Completion of 8 weeks of drinking tea and not undertake any major dietary changes
Agreement to refrain from starting any new herbal supplements or making significant dietary changes defined as a substantial alteration in macronutrient intake or the introduction of restrictive diets during the study period.
Agreement to discontinue the use of any other immune modulating interventions for at least 2 weeks before enrolment and throughout the study duration.
Participants should not be enrolled in any other trials. or planned surgery during the study period.  
 
ExclusionCriteria 
Details  Use of immunosuppressant medications methotrexate, azathioprine, cyclosporine or systemic corticosteroids prednisone within 3 months before enrollment. Inhaled or topical corticosteroids are permitted.
Pregnant or breastfeeding women
Participation in other clinical trials Participation in another interventional clinical trial within 30 days before enrollment. Observational studies are permitted.
Regular use more than 3 times per week of immunomodulatory supplements, such as Echinacea, Elderberry, and High dose vitamin C more than 1000 mg daily, Vitamin D more than 4000 IU daily, and Zinc more than 50 mg daily.
History of clinically significant liver or kidney disease, as determined by medical history and or elevated liver enzymes or creatinine levels during screening.
Known bleeding disorders hemophilia, von Willebrand disease or regular use of anticoagulant medications warfarin, heparin, direct oral anticoagulants.
Subjects with uncontrolled diabetes
Subjects who received vaccination for Influenza within the last 3 months
Subjects judged ineligible by the investigator
Subjects with a heart condition, malignant tumor, myocardial infarction, with a pacemaker or implantable cardioverter defibrillator ICD
Subjects who had undergone surgery in the last 2 weeks
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Turmeric Spice Herbal Tea in improving overall immunity compared to normal tea  Baseline and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the rate of infections and the duration of infection in subjects consuming Turmeric Spice Herbal Tea compared to normal tea
To assess the safety and tolerability of Turmeric Spice Herbal Tea compared to normal tea 		 Baseline and 8 weeks 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   29/08/2025 
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)  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  
Eligible participants will undergo a screening visit to confirm inclusion/exclusion criteria and obtain baseline data, including demographics, medical history, and concomitant medications.
Following the baseline assessment, eligible participants will be randomized to receive either Turmeric Spice Herbal Tea or the Normal tea (Assam Black Tea, Grade - Orthodox leaves). Participants will be instructed to consume one cup (150 mL) of the assigned tea twice daily for 8 weeks and SDC will be handed over for documentation of self-reporting study endpoints.
There will be telephonic follow-up at Day 7 and Day 28. Participants will attend follow-up visit on completion of 8 weeks of drinking tea at the site for assessment of their immune status based on ISQ scores, infection frequency and duration, adverse events. Data will be collected regarding the incidence, duration, and severity of self-reported infectious illnesses
 
Close