| CTRI Number |
CTRI/2025/04/084165 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study conducted on participants to assess working habits leading to lifestyle diseases due to sedentary lifestyle in the business community (Panyajeevi) |
|
Scientific Title of Study
|
Association between Lifestyle Diseases and Working Habits in The Business Community (Panyajeevi) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasad Kalya |
| Designation |
PG Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Dr D Y Patil Vidyapeeth Sant Tukaram Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9561005100 |
| Fax |
|
| Email |
prasadkalya43@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mrudula Joshi |
| Designation |
Head of Department |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9226279270 |
| Fax |
|
| Email |
mrudula.joshi@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Mrudula Joshi |
| Designation |
Head of Department |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri
Pune
MAHARASHTRA
411018
India |
| Phone |
9226279270 |
| Fax |
|
| Email |
mrudula.joshi@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Prasad Kalya |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Dr Mrudula Joshi |
Dr D Y Patil College of Ayurved and Research Centre Dr D Y Patil Vidyapeeth Sant Tukaram Nagar Pimpri |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prasad Kalya |
Dr D Y Patil College of Ayurved and Research Centre Dr DA Y Patil Vidyapeeth |
Sanskrit Samhita Evam Siddhant Department
Pune
MAHARASHTRA |
9561005100
prasadkalya43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.DYPCA and RC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hypertension
CVD
Dyslipidemia
Diabetes
Obesity
COPD
ASTHMA
Osteoarthritis
Stroke
PCOD |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: NIL, Ritucarya: NIL, Acara Rasayana:NIL, Other:, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Clothing and Grocery Merchants irrespective of their religion, sex, marital status, caste socio-economic status.
2) Merchants suffering with one or more lifestyle disorders.
3) Merchants in the same business for more than 5 years. |
|
| ExclusionCriteria |
| Details |
Merchants with congenital disorders, degenerative disorders, malignancy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between Lifestyle Diseases and Working Habits in The Business Community will be known. |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No any |
No any |
|
|
Target Sample Size
|
Total Sample Size="266"
Sample Size from India="266"
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)
|
01/05/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Participants will be selected according to Inclusion criteria.Written informed consent will be taken.
A structured questionnaire will be given to participants which will be in English/Hindi/Marathi.
Questionnaire will include all the etiology mentioned for Panyajeevi in the Ayurvedic Classics.
Etiological factors will be assessed.
Association between Lifestyle diseases and working habits in the business community will be evaluated.
Observation, data collection, statistical evaluation.
Discussion and Conclusion. |