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CTRI Number  CTRI/2020/07/026935 [Registered on: 31/07/2020] Trial Registered Prospectively
Last Modified On: 30/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Trial of Tulsi Original Green Tea in reducing daily stress 
Scientific Title of Study   A Clinical Trial of Tulsi Original Green Tea in reducing daily stress 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Sreedhar Rao 
Designation  Principal and Hospital Superintendent 
Affiliation  Shree Swaminarayan Ayurvedic College 
Address  Professor Department of Rog Nidan Room No 301 Opp Saij GIDC Kalol Dist Gandhinagar

Gandhinagar
GUJARAT
382725
India 
Phone  6351047973  
Fax    
Email  sreeayush@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Sreedhar Rao 
Designation  Principal and Hospital Superintendent 
Affiliation  Shree Swaminarayan Ayurvedic College 
Address  Professor Department of Rog Nidan Room 301 Opp Saij GIDC Kalol Dist Gandhinagar

Gandhinagar
GUJARAT
382725
India 
Phone  6351047973  
Fax    
Email  sreeayush@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M Sreedhar Rao 
Designation  Principal and Hospital Superintendent 
Affiliation  Shree Swaminarayan Ayurvedic College 
Address  Professor Department of Rog Nidan Room No 301 Opp Saij GIDC Kalol Dist Gandhinagar

Gandhinagar
GUJARAT
382725
India 
Phone  6351047973  
Fax    
Email  sreeayush@gmail.com  
 
Source of Monetary or Material Support  
Gujarat Tea Processors and Packers Ltd Wagh Bakri House Opp Parimal Garden Ambawadi Ahmedabad 380006 
 
Primary Sponsor  
Name  Gujarat Tea Processors and Packers Ltd 
Address  Wagh Bakri House Opp Parimal Garden Ambawadi Ahmedabad 
Type of Sponsor  Other [Tea Manufacturing Industry Indian] 
 
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 M Sreedhar Rao  Shree Swaminarayan Ayurvedic College Hospital  PSAM Hospital of Shree Swaminarayan Ayurvedic College Dept of Rog Nidan OPD No 1 Opp Saij GIDC Kalol
Gandhinagar
GUJARAT 
6351047973

sreeayush@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shree Swaminarayan Ayurvedic College IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Daily Stress 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Administration of Tulsi Original Green Tea   Combination of Ram tulsi Krishna tulsi Van tuli and Green with in equal proportion as tea bag of 2gms twice daily for 1 month(30 days) 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy Volunteer willing to participate in the study and signed informed consent 
 
ExclusionCriteria 
Details  Patients with any systemic disorders
Patients having depression and on medication for any psychiatric disorder
Pregnant Women
Patients who are under other investigational drugs 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Users may cope better with day to day stress level
May have improved sleep
quality
Improved anti oxidant serum level 
30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Immuno modulatory effect
Improved metabolism
Weight reduction
Uplifting Mood
Improves overall Wellness 
30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 4 
Date of First Enrollment (India)   03/08/2020 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Tulsi (Ossimum Sanctum) is known as Basil leaves are regarded as an ’adaptogen’ or anti-stress agent.  Recent studies have shown that the leaves afford significant protection against stress. It has several known health benefits in respiratory disorders, diabetes mellitus, skin disorders, pain management and acts also as immune modulators.

This clinical study has been planned to assess the ability of mixture of Ram tulsi, Shyam tulsi and Vanatulsi Green Tea (Tulsi Original Green Tea) in reducing Day to day stress in normal individual.  The study also intends to check the immunological response of Tulsi Original Green Tea in normal individual.  Almost 82 per cent of India’s population are suffering from stress and those in the sandwich generation (aged 35-49) are most affected with around 89 per cent reporting some level of stress, reveals the Cigna’s 360 well-being survey 2019.

Department of Roganidan and PSAM Hospital will be involved for 3 months period and the sample single group size will be 30.

The Material and Methods shall be Tulsi Original Green Tea will be distributed to people in the vicinity of Kalol who are voluntarily agreeing to participate in the trial and sign consent letter. Individuals participating in the trial will be assessed with subjective parameters like Pittsburg Sleep Quality Index (PSQI) questionnaire and  Hamilton Depression Rating Scale (HDRS) to assess day to day stress level on 1st  day, on 15th  day and on 30th  day. Objective parameters like Routine BP measuring on every visit, CBC,ESR, LFT, RFT, IgG, IgE, Anti oxidants will also be carried out before and after the study to ascertain the immune response developed by the Individual.

The proposed outcome is that Tulsi Original Green Tea is expected to be have effective result on reliving day to day stress in normal individuals; it also should bring about immune-modulatory effect.

 
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