| CTRI Number |
CTRI/2021/01/030475 [Registered on: 14/01/2021] Trial Registered Prospectively |
| Last Modified On: |
07/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
to understand the association between meda dhatu dushti i.e. a component of human tissue with diabetic patients next generation |
|
Scientific Title of Study
|
A Case Control Study Of MedaDhatuDushti In offspring of Diabetes Mellitus Type 2
Parents. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shivani gupta |
| Designation |
associate professor |
| Affiliation |
PDEA college of Ayurevd |
| Address |
1st floor, Rognidan department, YMT Ayurvrdic Medical College and Hospital kharghar, Navi Mumbai
department of Rognidan,PDEA college of Ayurevd, Akurdi
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9028007864 |
| Fax |
|
| Email |
drshivaniborele@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ragini Patil |
| Designation |
Dean an HOD |
| Affiliation |
MAHARASHTRA UNIVERSITY OF HEALTH SCIENCS |
| Address |
department of Rognidan,PDEA college of Ayurevd, Akurdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9422300242 |
| Fax |
|
| Email |
carcakurdi@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
shivani gupta |
| Designation |
associate professor |
| Affiliation |
PDEA college of Ayurevd |
| Address |
1st floor, Department of Rognidan, YMT Ayurvedic College and Hospital, kharghar, Navi Mumbai
Department of Rognidan,PDEA college of Ayurevd, Akurdi
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9028007864 |
| Fax |
|
| Email |
drshivaniborele@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra University of Health sciences, Nashik |
|
|
Primary Sponsor
|
| Name |
PDEAs college of Ayurved |
| Address |
P.D.E.A.s college of Ayurved |
| 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 |
| shivani gupta |
YMT Ayurvedic college and hospital |
ground floor, OPD of YMT Ayurvedic college and hospital, kharghar
Raigarh
MAHARASHTRA |
9028007864
drshivaniborele@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHIC COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
offsprings of diabetic parents
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
not having any major disorder like diabetes, hypertension |
|
| ExclusionCriteria |
| Details |
above or below age criteria.
having any major disorder like hypertention, diabetes |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between presence of Medadhatu dushti lakshan in offspring of Diabetic parents |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exposure rate in cases and controls for Meda dhatu dushti in the offsprings of Diabetic parents |
one time |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
29/01/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the study of pathological changes in Medadhatu and its dushti is assessed in the offsprings of diabetic parents. this parameter will access the pathological variation in those poeple who have diabetic parents.
|