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CTRI Number  CTRI/2025/06/088445 [Registered on: 09/06/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical
Other (Specify) [Herbal tea]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical Study to Check Effect & Safety of Chamomile Valerian Herbal Tea on Sleep Improvement and Reducing Anxiety in Healthy Humans. 
Scientific Title of Study   A Randomized, Double Blind, Single Centric, Placebo Controlled, Two Arm Clinical Study to Assess Efficacy & Safety of Chamomile Valerian Herbal Tea on Sleep Improvement and Reducing Anxiety in Healthy Humans. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
LT-CVT-CT01-25 Final version 01, Date- 06 MAY 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidyadhar Kumbhar 
Designation  Principal Investigator 
Affiliation  Sunad Ayurved 
Address  Siddhivinayak Apartment shop no. 2, 3, 4, Jeevan Nagar, Dhoka Colony, Chinchwad, Pimpri-Chinchwad, Pune, Maharashtra- 411033

Pune
MAHARASHTRA
411033
India 
Phone  9960075536  
Fax    
Email  dr.vidyadhar24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sornaraja Thasma  
Designation  Director Quality & Business 
Affiliation  ProRelix Services LLP 
Address  102 A/B, Park Plaza, Main Karve nagar chowk, Karve nagar, Pune, Maharashtra 411052

Pune
MAHARASHTRA
411052
India 
Phone  8124806366  
Fax    
Email  s.thasma@prorelixresearch.com  
 
Details of Contact Person
Public Query  
Name  Mrs Aditi Vaidya  
Designation  Senior Manager- Clinical Research Operations 
Affiliation  ProRelix Services LLP 
Address  102 A/B, Park Plaza, Main Karve nagar chowk, Karve nagar, Pune, Maharashtra 411052

Pune
MAHARASHTRA
411052
India 
Phone  8602571013  
Fax    
Email  a.vaidya@prorelixresearch.com  
 
Source of Monetary or Material Support  
Luxmi Tea Co. Private Limited, Floor No.: 7th, Building No.: 17, Kishore Bhavan, R.N. Mukherjee Road, Kolkata, West Bengal 700001 
 
Primary Sponsor  
Name  Luxmi Tea Co. Private Limited 
Address  Floor No 7th, Building No 17, Kishore Bhavan, R.N. Mukherjee Road, Kolkata, West Bengal 700001 
Type of Sponsor  Other [Nutraceutical 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 Vidyadhar Kumbhar  Sunad Ayurved  Siddhivinayak Apartment shop no. 2, 3, 4, Jeevan Nagar, Dhoka Colony, Chinchwad, Pimpri-Chinchwad, Pune, Maharashtra- 411033
Pune
MAHARASHTRA 		 9960075536

dr.vidyadhar24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sleep disturbance and anxiety otherwise healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chamomile Valerian Herbal Tea   Subject will be instructed to drink Chamomile Valerian Herbal tea twice daily once in the evening between 5 to 7 PM, and once 30 to 60 minutes before sleep, for 45 days that is Day 1 to Day 45. To make each cup, use 2 grams of tea that is 1 tea bag in 150 ml of hot water. 
Comparator Agent  Placebo- Identical product without active ingredient   Subject will have instructed to drink placebo twice daily once in the evening between 5 to 7 PM, and once 30 to 60 minutes before sleep, for 45 days that is Day 1 to Day 45. To make each cup, use 2 grams of tea that is 1 tea bag in 150 ml of hot water. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Males or females above the age of 18 years who experience anxiety and have difficulty initiating and or maintaining sleep.
2. Subject or the subject’s legally authorized representative willing to give written informed consent.
3. Subjects willing to come for visits at the site as per protocol.
4. Non-Smoker.
5. Subject should not be on Antidepressant or any medication for anxiety.
6. Subject should not be on sleep medication.
7. Subject should not be consuming any dietary supplements consisting Chamomile or Valerian till the end of study.
 
 
ExclusionCriteria 
Details  1. Pregnant, lactating women.
2. Subjects consuming sedative hypnotics, benzodiazepines, cyclopyrrolones, imidazopyridines, barbiturates, etc.
3. Severe psychiatric disorders.
4. Restless legs or leg cramps that influence sleep and everyday life.
5. Conditions that prevent sleep through the symptoms that they produce (pain, nightly coughs, etc.).
6. Breathing problems (asthma, severe snoring, sleep apnea, etc).
7. Subjects with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy.
8. Irregular work hours, including shift work at night.
9. Subject consuming alcohol.
10. High caffeine intake (More than 10 cups per day) or equivalent caffeine intake from other caffeinated drinks example tea, energy drinks.
11. Contraindication or allergy to any substance in the investigational product.
12. Currently, or within the past 30 days, enrolled in a different clinical investigation.
13. Unable or unwilling to provide written informed consent for participation in the study.
14. Subjects suffering from chronic illness or any other condition that, in the opinion of the investigator, may compromise the safety and compliance of the participant or preclude the study. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluation of Sleep: Total Sleep Time and the Number of Awakenings Post Sleep Onset using Sleep Diary , Evaluation of Quality of Sleep through Sleep Quality Scale (SQS) score, Evaluation of Anxiety: Hamilton Anxiety Rating Scale (HAM-A) score.  Screening and Baseline (Day 0) and end of study (Day 46) 
 
Secondary Outcome  
Outcome  TimePoints 
1. Evaluation of Day Functionality through Stanford Sleepiness Scale (SSS) score
2. Evaluation of Quality of Life through World Health Organization-Five Well-Being Index (WHO-5)
3. Safety Lab – Complete Blood Count (Haemoglobin, Haematocrit, RBC count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Platelet count, White blood cell count)
4. Treatment Emergent Adverse Event
 		 Screening and Baseline (Day 0) and end of study (Day 46) 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   23/06/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

This is a randomized, double blind, single centric, placebo controlled, two arm clinical study. A total of 32 subjects, including approx. 10 percent dropout will be screened and randomly assigned in 1 is to 1 ratio to Chamomile Valerian Herbal Tea or Placebo group that is 16 subjects in each group. The duration of each subject’s participation in the study will be of 46 days and the treatment period is 45 days (IP will be administered from Day 1 to Day 45). Efficacy and safety assessments will be done at both the visits. Subjects will be asked to bring their unused IP and AE diaries along with sleep diaries at the end of study.

 
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