| CTRI Number |
CTRI/2024/12/077990 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A survey study to assess stress among tea consumers in age group between 20-60 years. |
|
Scientific Title of Study
|
A cross sectional study to assess stress among tea consumers in age group between 20-60 years. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajkta Adhao |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi, Pune |
| Address |
Department of Swasthavritta and Yoga, PDEAs College of Ayurved and Research Centre, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9579917449 |
| Fax |
|
| Email |
prajuadhao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajkumar Bobade |
| Designation |
Head of Department |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
Department of Swasthavritta and Yoga, PDEAs College of Ayurved and Research Centre, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9403928005 |
| Fax |
|
| Email |
rajkumarbobade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajkumar Bobade |
| Designation |
Head of Department |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
Department of Swasthavritta and Yoga, PDEAs College of Ayurved and Research Centre, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9403928005 |
| Fax |
|
| Email |
rajkumarbobade@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre, Nigdi, Pune, Maharashtra, India, Pin-411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune, Maharashtra, India, Pin - 411044 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prajkta Adhao |
PDEAs College of Ayurved and Rsearch Centre |
Department of Swasthavritta, Room No.123B, PDEAs College of Ayurved and Research Centre, Sector No. 25 Nigdi, Pune 411044
Pune
MAHARASHTRA |
9579917449
prajuadhao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Standard Operating Procedure for Institutional Ethical Committee- for Human Rsearch at Pune District Education Associations College of Ayurved & Research Centre Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers of age 20 to 60 years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | NIL | (Procedure Reference: NIL, Procedure details: NIL)
| | 2 | Comparator Arm | Procedure | - | NIL | (Procedure Reference: NIL, Procedure details: NIL)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers of age group 20 to 60 years who consumes tea irrespective of sex and religion. |
|
| ExclusionCriteria |
| Details |
Ischemic heart disease, chronic kidney disease, diabetis mellitus, Malignancy. Pregnancy and Lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess stress among tea consumers in age group between 20-60 years. |
One time survey will be done for 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="322"
Sample Size from India="322"
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)
|
23/12/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
1948 World Health Organisation (WHO) defined the term Health as ’a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity. The main principle of Ayurveda, which states that retaining the health of healthy person first and to cure the diseased (vyadhi). Swasthvritta which mainly focuses on diet (ahara) and lifestyle. Trayopastambha in ayurveda refers to three pillars i.e. Ahara (Diet), Nidra (Proper sleep), and Bramhacharya (Abstinence).
In recent decades, lifestyle as an important factor of health is more interested by researchers. According to WHO 60% of related factors to individual health and quality of life are correlated to lifestyle. Millions of people follow unhealthy lifestyle. Hence, they encounter illness, disability and even death. 14l In our day to day life we all face many challenges like work pressure, financial problems, health issues, academic pressure, and many other uncertainties and because of that we feel stressed.
Stress affects both the mind and body. A little bit of stress is good and can help us perform daily activities. Too much stress can cause physical and mental health problems. Stress can be defined as a state of worry or mental tension caused by difficult situation. Stress is natural human responses that prompts us to address challenges and threats in our lives. Stress Everyone experiences stress to some degree. The way we respond to stress, however, makes a big difference to our overall well being. Everyone reacts differently to stressful situations. Coping styles and symptoms of stress vary from person to person.
Tea, the most popular beverage consumed by two-thirds of the world’s population is made from the processed leaf of Camellia sinensis Linn. India is the second largest producer of tea in the world and accounts for the highest tea consumption globally. Around 80% of the total tea produced in India is consumed by the domestic population.
Milk tea with sugar is the most popular choice with more than 80% of the households preffering the same. Tea next to water is cheapest beverage humans consume. Drinking the beverage tea has been considered a health promoting habit since ancient times.
Rationale of study: Tea: Most Popular beverage. Consumed by two-thirds of the world population. Stress: It is natural and unavoidable part of life. It refers to physical, mental, and emotional strain or tension that individuals experience when faced with challenging or demanding circumstances. People find various ways to overcome stress but Tea, next to water is the cheapest beverage humans consume.
To find out relation of stress and tea consumption there is a need to do more work hence the study has been selected. |