| CTRI Number |
CTRI/2024/07/071066 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study to understand the relation between ayurveda parameters and modern parameters of assessing the body tissues. |
|
Scientific Title of Study
|
A Cross-sectional Study to evaluate the association between Ayurveda Parameters of Dhatu Sarata and Modern Parameters (CBC, BMI, BMD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Sunad/CT/2024/001, Version 01, Dated April 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Sagar Patil |
| Designation |
Consultant |
| Affiliation |
Tulsi Ayurved |
| Address |
Tulsi Ayurved, near society gate Chatrapati chowk, near sonigara kesar, beside Durga cafe, Dynasty society, Vishnu dev nagar, Wakad
Pune
MAHARASHTRA
411057
India |
| Phone |
9545201401 |
| Fax |
|
| Email |
drshweta1612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidyadhar Kumbhar |
| Designation |
Managing Director |
| Affiliation |
Sunad Gardan |
| Address |
Sunad Garden, Jeevan Nagar, Dhoka Colony,Opp. Dhoka Pratistan,Near Ramkrishna Auditorium Hall, Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
9960075536 |
| Fax |
|
| Email |
dr.vidyadhar24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidyadhar Kumbhar |
| Designation |
Managing Director |
| Affiliation |
Sunad Gardan |
| Address |
Sunad Garden, Jeevan Nagar, Dhoka Colony,Opp. Dhoka Pratistan,Near Ramkrishna Auditorium Hall, Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
9960075536 |
| Fax |
|
| Email |
dr.vidyadhar24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sunad Garden LLP siddhivinayak apartment jeevan nagar dhoka colony Chinchwad Pune Maharashtra India 411033 |
|
|
Primary Sponsor
|
| Name |
Sunad Gardan |
| Address |
Sunad Garden, Jeevan Nagar, Dhoka Colony,Opposite Dhoka Pratistan,Near Ramkrishna Auditorium Hall,Chinchwad, Pune 411033 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pranali Subhash Giradkar |
Aadya Ayurved |
Shop no 45 Vision flora mall, Kunal Icon Road Pimple Saudagar Pune 411027
Pune
MAHARASHTRA |
8275283618
pranaligiradkar@gmail.com |
| Dr Shweta Sagar Patil |
Tulsi Ayurved |
Near society gate Chatrapati chowk near sonigara
kesar beside Durga cafe Dynasty society Vishnu dev nagar Wakad Pune 411057
Pune
MAHARASHTRA |
9545201401
drshweta1612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics committee |
Approved |
| Royal Pune Independent Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-60 years
Willingness to undergo Ayurveda health analysis and modern health assessments
|
|
| ExclusionCriteria |
| Details |
Pregnancy or lactation
Participation in other clinical trials currently
Those who are taking supplements
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Association between Ayurveda Parameters (Dhatu Sarata) and
Modern Parameters (CBC, BMI, BMD) |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the overall health status with the help of sarata
questionnaire |
Day 1 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
14/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
To evaluate the association between theAyurved parameters of Raktasrata, Mamsasarata, Medosarata and Asthisarata with modern parameters of CBC, BMI, BMD respectivelyTo evaluate the overall health status with the help of sarata questionnaire |