A Clinical Trial of Tulsi Original Green Tea in reducing daily stress
- Conditions
- Daily Stress
- Registration Number
- CTRI/2020/07/026935
- Lead Sponsor
- Gujarat Tea Processors and Packers Ltd
- Brief Summary
Tulsi(Ossimum Sanctum) is known as Basil leaves are regarded as an ’adaptogen’ oranti-stress agent. Recent studies have shown that the leaves affordsignificant protection against stress. It has several known health benefits inrespiratory disorders, diabetes mellitus, skin disorders, pain management andacts also as immune modulators.
This clinical study has been planned to assess theability of mixture of Ram tulsi, Shyam tulsi and Vanatulsi Green Tea (TulsiOriginal Green Tea) in reducing Day to day stress in normal individual. The study also intends tocheck the immunological response of Tulsi Original Green Tea in normalindividual. Almost 82 per cent of India’spopulation are suffering from stress and those in the sandwich generation (aged35-49) are most affected with around 89 per cent reporting some level ofstress, reveals the Cigna’s 360 well-being survey 2019.
Department of Roganidan and PSAM Hospital will beinvolved for 3 months period and the sample single group size will be 30.
The Material and Methodsshall be Tulsi Original Green Tea will be distributedto people in the vicinity of Kalol who are voluntarily agreeing to participatein the trial and sign consent letter. Individuals participating in the trialwill be assessed with subjective parameters like Pittsburg Sleep Quality Index (PSQI)questionnaire and Hamilton Depression Rating Scale (HDRS) to assess dayto day stress level on 1st day, on 15th dayand on 30th day. Objective parameters like Routine BPmeasuring on every visit, CBC,ESR, LFT, RFT, IgG, IgE, Anti oxidants will alsobe carried out before and after the study to ascertain the immune responsedeveloped by the Individual.
The proposed outcome isthat Tulsi Original Green Tea is expected to be haveeffective result on reliving day to day stress in normal individuals; it alsoshould bring about immune-modulatory effect.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
Healthy Volunteer willing to participate in the study and signed informed consent.
Patients with any systemic disorders Patients having depression and on medication for any psychiatric disorder Pregnant Women Patients who are under other investigational drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Users may cope better with day to day stress level 30 days May have improved sleep 30 days quality 30 days Improved anti oxidant serum level 30 days
- Secondary Outcome Measures
Name Time Method Immuno modulatory effect Improved metabolism
Trial Locations
- Locations (1)
Shree Swaminarayan Ayurvedic College Hospital
🇮🇳Gandhinagar, GUJARAT, India
Shree Swaminarayan Ayurvedic College Hospital🇮🇳Gandhinagar, GUJARAT, IndiaDr M Sreedhar RaoPrincipal investigator6351047973sreeayush@gmail.com