| CTRI Number |
CTRI/2018/12/016802 [Registered on: 31/12/2018] Trial Registered Prospectively |
| Last Modified On: |
24/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out which prakruti is predominantly found in Diabetes Mellitus |
|
Scientific Title of Study
|
An observational study to determine relative prevalence rate of Diabetes Mellitus type 2 in different Deha Prakrutis.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pallavi Sureshrao Bhirange |
| Designation |
MD final year |
| Affiliation |
CARC |
| Address |
College ofAyurveda and research centre, (sharir kriya department)) akurdi 25, Nigdi,Pune 44
Nigadi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7028032245 |
| Fax |
|
| Email |
bhirangepallavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta More |
| Designation |
Associate professor |
| Affiliation |
CARC |
| Address |
College ofAyurveda and research centre, (sharir kriya department)) akurdi 25, Nigdi,Pune 44
Nigadi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9730473931 |
| Fax |
|
| Email |
shwetmore85@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Sureshrao Bhirange |
| Designation |
MD final year |
| Affiliation |
CARC |
| Address |
College ofAyurveda and research centre, (sharir kriya department)) akurdi 25, Nigdi,Pune 44
Nigadi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7028032245 |
| Fax |
|
| Email |
bhirangepallavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved and sterling multispeciality hospital,akurdi,nigadi pune 411044 |
|
|
Primary Sponsor
|
| Name |
CARC |
| Address |
Nigadi Pune |
| 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 |
| Dr shweta more |
ayurved and sterling multispeciality hospital,medicine department. |
sector 27, bhel chowk, nigadi, pradhikaran,pimpari-chinchwad, pune, maharashtra 411044
Pune
MAHARASHTRA |
9730473931
shwetmore85@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
recently diagnosed case of type 2 diabetes mellitus with history upto 3 year |
|
| ExclusionCriteria |
| Details |
patient with diabetes mellitus type 1
patient of gestational diabetes and juvenile diabetes
known case of type 2 diabetes mellitus associated with complication such as ischemic heart disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| conclussion will be drawn strictly based on statistical analysis |
every 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| proneness of Prakruti in diabetes mellitus type 2 |
every 6 month |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/01/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
diabetes mellitus is a major public health issue which is aproaching epidemic proportion gloabally. it is fast becoming the world largest silent killer |