| CTRI Number |
CTRI/2022/10/046940 [Registered on: 31/10/2022] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to evaluate the status of Dhatu Sarata in Diabetes |
|
Scientific Title of Study
|
Evaluation of status of Dhatu sarata in Prameh (Diabetes mellitus): Cross sectional case-control study . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJaimini Rathod |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
116,kayachikitsa opd
parul ayurved hospital
parul university
Limda
Vadodara
GUJARAT
391760
India |
| Phone |
8200984866 |
| Fax |
|
| Email |
jaiminiguddi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Deshpande |
| Designation |
Professor |
| Affiliation |
parul institute of ayurveda |
| Address |
116,kayachikitsa opd,
Parul Ayurved hospital
Parul University
Limda,Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
09763104451 |
| Fax |
|
| Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Professor |
| Affiliation |
Parul institute of Ayurved and Reaserch, Parul University, Limda,Gujarat |
| Address |
8,kayachikitsa opd,
Khemadas ayurved hospital
parul university
Ishwarpura
Vadodara
GUJARAT
391760
India |
| Phone |
09096082950 |
| Fax |
|
| Email |
dr.vaishalid@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of Ayurveda
Parul University |
|
|
Primary Sponsor
|
| Name |
Dean and principal faculty of Parul institute ofAyurveda |
| Address |
Parul institute of Ayurved and Reaserch
Parul University
Limda,Gujarat |
| 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 Shailesh Deshpande |
Parul Ayurved Hospital |
116,kayachikitsa opd
Parul Ayurved hospital
Parul University
Limda,Gujarat
Vadodara
GUJARAT |
9763104451
dr.shaileshd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of Parul institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals with no any other Endocrine
Disorders |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Known case of Diabetes mellitus.
2)Patients willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1)Known case of Diabetes mellitus with other endocrine disorders.
2)Patient with immunocompromised status like HIV.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| dhatu sarata on the basis of JAIM-Proforma for sara assessment scale |
at baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| involvement of Dushyas in Prameh |
at baseline only |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2022 |
| Date of Study Completion (India) |
28/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/07/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes mellitus is a group of metabolic diseases in which the person has high blood glucose (blood sugar) level either due to inadequate insulin production or because the body’s cells do not respond properly to insulin or both. Dhatu Sara is explained by their respective attributes (Guna) and physical appearance.It becomes difficult to assess Sara on this basis and hence no
uniformity has been observed among physicians for its assessment as various
criteria for Dhatu Sara are mainly subjective and cannot be easily
carried out. Dhatu Sara is un-fluctuating strength of a body
tissue.. Excellent state of body
tissues is related with good strength and poor state of body tissues is related
with weakness. Hence manifestations of Dhatu Asara (poor state of body
tissue) can be looked upon as possible symptoms of Dhatu Shaithilya.
Some diseases also lead to Asara (poor state) of particular body
tissues.
Involvement of Dushyas in Prameh (Diabetes mellitus) will be evaluated on the basis of JAIM-Proforma for sara assessment scale. Dhatu sarata-asarata will be analysed between the groups and within the group. |