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CTRI Number  CTRI/2025/08/093527 [Registered on: 25/08/2025] 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   Dandelion Herbal Tea Study on Overall Detoxification 
Scientific Title of Study   Efficacy and Tolerability of Pure Dandelion Herbal Tea on Overall Detoxification in Healthy Adults: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MC/DHT/25-004 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 Sandip Rungta   Mansa Sheel Clinic  Mansa Sheel Residency , 1, Raja Gurudas Street , Near Minerva Theatre Above axis Bank , Kolkata : 700006
Kolkata
WEST BENGAL 		 9831231450

sandiprungta@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)  Normal tea - Assam Black Tea, Grade - Orthodox leaves: Serving Size- 2g in 150 ml hot water, 3 mins brewing in about to boil water temp. Recommended consumption: One cup 150 ml of Normal Tea twice daily for 8 weeks. Duration: 8 weeks 
Intervention  Pure Dandelion Herbal Tea  Pure Dandelion Herbal Tea: Serving Size- 2g in 150 ml hot water, 5 mins brewing in about to boil water temp. Recommended consumption: Consumption of one cup of Pure Dandelion 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  Males and females aged between 18 and 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 Dandelion 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 detoxification programs during the study period
Agreement to limit alcohol consumption to no more than 2 standard drinks per day for males and 1 standard drink per day for females throughout the study period
Agreement to maintain stable caffeine consumption throughout the study period  
 
ExclusionCriteria 
Details  History or presence of clinically significant liver disease
History or presence of clinically significant kidney disease
History or presence of gastrointestinal disorders that could significantly affect digestion or bowel habits inflammatory bowel disease, Crohns disease, ulcerative colitis, celiac disease, irritable bowel syndrome requiring regular medication
History of gastrointestinal surgery that may affect absorption
Uncontrolled diabetes mellitus
History of cardiovascular disease myocardial infarction, stroke, heart failure, unstable angina within 6 months before screening
Uncontrolled hypertension
History of malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer
Presence of any condition that, in the investigators opinion, would compromise the subject safety or compliance, or interfere with the interpretation of study results
Known allergy or hypersensitivity to dandelion or other plants
History of severe allergic reactions or anaphylaxis to any food or drug
Use of prescription medications known to affect liver function, kidney function, digestion, or bowel habits, unless the medication has been stable for at least 3 months before screening and is expected to remain stable throughout the study period
Use of any over the counter medications or supplements known to affect liver function, kidney function, digestion, or bowel habits within 30 days 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 Dandelion Herbal Tea compared to normal tea in improving overall detoxification  Baseline and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of Pure Dandelion Herbal Tea on sleep quality compared to normal tea
To explore the changes in general well-being and quality of life in participants consuming Pure Dandelion Herbal Tea compared to normal tea
To evaluate the safety and tolerability of Pure Dandelion Herbal Tea compared to normal tea 		 Baseline and 8 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   07/08/2026 
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="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 screening, informed consent, and baseline data collection. At the baseline visit (Day 0), participants will receive a subject diary card (SDC) to record weekly urine output (frequency, colour, and volume), bowel movement frequency, and stool consistency [(utilizing Bristol Stool Form Scale (BSFS)], and complete the World Health Organization-Five Well-being Index (WHO-5) and Pittsburgh Sleep Quality Index (PSQI) questionnaires. They will then be randomized to Pure Dandelion Herbal Tea or normal tea. Participants will be instructed to for preparation of tea and consume one cup (150 mL) of the assigned tea twice daily for 8 weeks. There will be telephonic follow-up at Day 7 and Day 28. Final visit on completion of 8 weeks will include reviews of SDC to assess changes in urine output, bowel frequency, and stool consistency. The final visit on completion of 8 weeks will also include assessment through WHO-5 and PSQI questionnaires to check any changes in well-being and sleep quality, respectively. Adverse events and adherence to study instructions will be assessed for the entire study period utilizing the self-reported SDC and clinical evaluation (as applicable). Data will be analysed to compare changes in urine output, bowel frequency, stool consistency, WHO-5 scores, PSQI scores, and adverse event incidence between groups from baseline to 8 weeks. 
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