| CTRI Number |
CTRI/2024/05/068215 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Physical Activity & Diet On Mamsa Dhatu Samhanan |
|
Scientific Title of Study
|
Comparative Study To Assess The Effect Of Physical Activity & Diet On Mamsa Dhatu Samhanan In Healthy Volunteers Of Vadodara District In Different Occupation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kinjal Rohit |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda Parul University Limda Waghodia
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda Parul University Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
09898130834 |
| Fax |
|
| Email |
rohitkinjal1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Yadnik |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda Parul University Limda Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9421655695 |
| Fax |
|
| Email |
narendra.yadnik26836@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Yadnik |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda Parul University Limda Waghodia
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda Parul University Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9421655695 |
| Fax |
|
| Email |
narendra.yadnik26836@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurved Parul University Vadodara Gujarat |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda Parul University Limda Waghodia Vadodara GUJARAT 391760 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrKinjal Rohit |
Parul Institute Of Ayurved |
105 Ground Floor Kriya Sharir Department Parul Institute Of Ayurveda Parul University Limda Waghodia
Vadodara
GUJARAT |
9898130834
rohitkinjal1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute Of Ayurved-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Apparently Healthy volunteers irrespective of gender,caste,religion |
|
| ExclusionCriteria |
| Details |
1)Persons having any type of major systemic diseases
2)Pregnant ladies
3)People suffering from extreme psychological condition will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skinfold Thickness, Fatigue, Grip Strength, Mansa Dhatu Sarata |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse event during examination of Grip strength, Endurance, chair squat test. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
01/06/2024 |
| 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="1"
Months="0"
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
|
1)At OPD or IPD level, it is important to examine Samhanana of persons for better understanding of the Bala of patients for treatment, so it is an attempt to develop assessment tool/protocol to check the quality and quantity of mamsa dhatu in different occupations.
2)As per previous study available, no one has tried to develop such tool. So this study will provide a quantitative assessment criteria for mamsa dhatu Samhanana. |