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CTRI Number  CTRI/2025/08/093140 [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   Ashwagandha-Turmeric Herbal Tea Study for Stress Relief 
Scientific Title of Study   Efficacy of Ashwagandha-Turmeric Herbal Tea for Stress Relief in Healthy Adults: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MC/ATHT/25-006 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, HP Poddar Memorial Clinic and Nursing Home  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Generally healthy individuals with self-reported stress levels 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha-Turmeric Herbal Tea  Ashwagandha-Turmeric Herbal Tea: Serving Size- 2g (tea bag) in 150 ml hot water, 5 mins brewing at about to boil water. Recommended consumption: Consumption of one cup of Ashwagandha-Turmeric Herbal Tea twice daily for 8 weeks. Duration: 8 weeks 
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 at about to boil water. Recommended consumption: One cup (150 ml) of Normal 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  Male and Female adults aged 18 to 65 years both inclusive
Generally healthy individuals, as determined by medical history and physical examination
Self-reported stress levels, indicated by a score of 14 or more on the Perceived Stress Scale PSS
Participants should have a score less than 15 on the World Health Organization five WHO 5 well being index
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 Ashwagandha Turmeric 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
Agreement to maintain a stable diet throughout the study period Day 0 to completion of 8 weeks and not undertake any major dietary changes
Participants should be free of psychiatric conditions other than stress, as determined by medical history and the investigator.
Agreement to discontinue the use of any other herbal supplements or stress-reducing interventions aromatherapy, meditation 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  Known allergy or sensitivity to Ashwagandha, turmeric, or other ingredients in the herbal tea
Current use of antidepressant, anti anxiety, or sleep altering medications
Use of anticoagulant or antiplatelet medications
Use of immunosuppressant medications
Use of thyroid hormone medication, unless the condition is stable for at least 6 months
Under diagnosis of any major psychiatric disorder
History of significant gastrointestinal disease
Pregnant or breastfeeding women
Uncontrolled hypertension or unstable cardiovascular disease
Uncontrolled diabetic patients
Hyperthyroidism or uncontrolled hypothyroidism
Participation in another clinical trial within the past 30 days.
Subjects with a score of 15 or higher on the World Health Organization five WHO 5 well being index
Any other significant medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study or could interfere with the interpretation of the study results.
Participants were currently taking any herbal preparations or formulations containing Ashwagandha, ginseng, ginkgo biloba, Brahmi, or related herbs
Participants suffering from any chronic physical, hormonal, or psychiatric illness
Participants with abnormal laboratory or ECG findings
Participants having any substance dependence  
 
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 Ashwagandha-Turmeric Herbal Tea in reducing perceived stress levels in healthy adults compared to normal tea  Baseline and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of Ashwagandha-Turmeric Herbal Tea on anxiety levels compared to normal tea
To evaluate the effect of Ashwagandha-Turmeric Herbal Tea on sleep quality compared to normal tea
To explore the changes in general well-being and quality of life in participants consuming Ashwagandha-Turmeric Herbal Tea compared to normal tea
To assess the safety and tolerability of Ashwagandha-Turmeric Herbal Tea compared to normal tea 		 Baseline and 8 weeks 
Exploratory Endpoint
To evaluate the effect of Ashwagandha Turmeric Herbal Tea on cortisol levels compared to normal tea 		 Baseline and 8 weeks 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 provide informed consent, undergo a medical history review, and a physical examination. Baseline PSS, DASS, PSQI, and WHO-5 scores will be collected, along with a blood sample for assessment of baseline cortisol levels.
Participants meeting all inclusion criteria and no exclusion criteria will be randomized to either the Ashwagandha-Turmeric Herbal Tea group or the control group.
Following the baseline assessment, eligible participants will be randomized to receive either Ashwagandha-Turmeric Herbal Tea or the Normal tea (Assam Black Tea, Grade - Orthodox leaves). Participants will be instructed to for preparation of tea and 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 for the assessment of compliance, adverse events, and interim efficacy measures. After completion of 8 weeks, PSS, DASS, PSQI, and WHO-5 scores will be collected, along with a blood sample for cortisol levels and a final assessment of adverse events.
 
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