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CTRI Number  CTRI/2025/08/093141 [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   Peppermint Herbal Tea Study on Overall Digestion 
Scientific Title of Study   Efficacy and Tolerability of Pure Peppermint Herbal Tea on Overall Digestion in Healthy Adults: A Randomized-Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MC/PHT/25-005 Version Number: 1.0 / Date: 12 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 Indraneel Saha  Pulse Diagnostic Centre  96/2, Sarat Bose Road , Kolkata - 700026
Kolkata
WEST BENGAL 		 9831000396

isjsid@yahoo.co.in  
 
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  Generally healthy individuals experiencing occasional digestive discomfort e.g., bloating, gas, indigestion, abdominal discomfort, altered bowel habits, dyspepsia with little or no pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal tea (Assam Black Tea, Grade - Orthodox leaves)  Serving Size- 2g in 150 ml hot water, brewing time - 3 mins in about to boil water temp. Recommended consumption: One cup (150 ml) of Normal Tea twice daily for 8 weeks. 
Intervention  Pure Peppermint Herbal Tea  Serving Size- 2g in 150 ml hot water, brewing time – 5 mins in about to boil water temp. Recommended consumption: One cup of Pure Peppermint Herbal Tea twice daily for 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, inclusive
Generally healthy individuals, as determined by medical history and physical examination
Experiencing occasional digestive discomfort bloating, gas, indigestion, abdominal discomfort, altered bowel habits, dyspepsia with little or no pain at least once a week for the past one month before screening
Stable health status for at least 3 months before screening visit
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, willing and able to comply with all study procedures, including daily consumption of the assigned tea Pure Peppermint Herbal Tea or Normal tea prepared as per direction provided and continuing for the duration of the study, attending scheduled study visits, and completing all required questionnaires and subject diaries.
Access to a telephone and the ability to be contacted by study personnel
Ability to communicate effectively with study personnel
Agreement to maintain a stable diet throughout the study period Day 0 to 8 weeks and not undertake any major dietary changes
Agreement to refrain from starting any new exercise programs or significantly altering physical activity levels during the study period
Willingness to abstain from other herbal supplements, teas, or digestion improvement programs during the study period 
 
ExclusionCriteria 
Details  Diagnosis or history of any chronic gastrointestinal disorder, including but not limited to irritable bowel syndrome IBS, inflammatory bowel disease IBD Crohns disease, ulcerative colitis, celiac disease, gastroesophageal reflux disease GERD requires continuous treatment, chronic constipation or diarrhoea, known gastrointestinal motility disorders
History of major gastrointestinal surgery excluding appendectomy or cholecystectomy that could significantly alter digestive function
Use of prescription medications for digestive health within 2 weeks before screening, including Proton pump inhibitors PPIs, H2 receptor antagonists, Antacids regular, chronic use, Laxatives regular, chronic use, Antidiarrheals regular, chronic use, Prokinetics, Digestive enzymes and Antibiotics
Known allergy or sensitivity to peppermint or related plants other members of the Lamiaceae family
Pregnant or breastfeeding women, or women planning to become pregnant during the study period
Participation in another clinical trial or intervention study within 30 days before screening
Uncontrolled diabetes, cardiovascular disease, renal or hepatic impairment, autoimmune disorders, and active infections
History of alcohol or substance abuse that, in the opinion of the investigator, could interfere with study compliance or data interpretation.
Presence of any unstable psychiatric condition that, in the opinion of the investigator, could interfere with study compliance or data interpretation
History of recent or active infectious illnesses common cold, influenza, gastroenteritis within 2 weeks before screening 
 
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 Pure Peppermint Herbal Tea in improving overall digestion compared to normal tea  Baseline and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the frequency of bowel movements and stool consistency in two treatment groups
To evaluate the safety and tolerability of Pure Peppermint Herbal Tea compared to normal tea 		 Baseline and 8 weeks 
 
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   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. Participants will be randomly assigned to either the Pure Peppermint Herbal Tea group or the Normal tea group. Subject diary cards will be handed over for documentation of self-reported study endpoints. Participants will consume the assigned tea (Pure Peppermint Herbal Tea or normal tea) twice daily for 60 days. Two telephonic follow-ups will be conducted on Day 7 and Day 28.
Participants will attend two study visits:
Visit 1: Baseline (Day 0) - Informed consent, eligibility assessment, subject diary card (SDC) distribution, baseline data collection (overall digestive and lifestyle (DLQL) score, bowel movement assessment and BSFS scoring, vital signs, concomitant medication.
Visit 2: Completion of 8 weeks – Retrieval of SDC, final assessment of study endpoints captured in SDC, digestive and lifestyle (DQLQ) score, bowel movement assessment and BSFS scoring, vital signs, adverse events and tolerability assessment.
 
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