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
|
|
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
|
|
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. |