CTRI Number |
CTRI/2019/10/021675 [Registered on: 16/10/2019] Trial Registered Prospectively |
Last Modified On: |
11/10/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
TO UNDERSTAND THE RELATION BETWEEN DURATION OF DIABETES AND KIDNEY PROBLEM WITH LAB REPORT |
Scientific Title of Study
|
A CROSS SECTIONAL STUDY TO ANALYZE THE RELATION BETWEEN DURATION OF PRAMEHA(DM) AND RENAL DYSFUNCTIONS WITH CYSTATIN-C(SERUM MARKER FINDING) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
other |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrSachinDeva |
Designation |
Reader/PhD Scholar |
Affiliation |
Parul Institute of Ayurved |
Address |
Reader/PhD Scholar,
PG Dept of RogaNidana
Parul Institute of Ayurved,Limda Post,Waghodia Taluk,Vadodara,GUJARAT 391760 Parul University,Vadodara,Gujarat
391760 Vadodara GUJARAT 391760 India |
Phone |
9844810957 |
Fax |
|
Email |
sachin.deva@paruluniversity.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
DrUrvi Dave |
Designation |
Professor |
Affiliation |
Parul University |
Address |
Professor
Dept of RogaNidana
Parul Institute of Ayurveda and Research
Waghodia Road Vadodara
Vadodara GUJARAT 391760 India |
Phone |
9537571276 |
Fax |
|
Email |
daveurvi29@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrSachinDeva |
Designation |
Reader/PhD Scholar |
Affiliation |
Parul University |
Address |
Reader/PhD Scholar,
PG Dept of RogaNidana
Parul Institute of Ayurved,Limda Post,Waghodia Taluk,Vadodara,GUJARAT 391760
Vadodara GUJARAT 391760 India |
Phone |
9844810957 |
Fax |
|
Email |
sachin.deva@paruluniversity.ac.in |
|
Source of Monetary or Material Support
|
Parul Ayurveda Hospital
Parul Sevashram Hospital Khemdas Ayurveda Hospital
PARUL UNIVERSITY
PO Limda
tal- Waghodia
Vadodara
391760 |
|
Primary Sponsor
|
Name |
Parul Institute of Ayurveda |
Address |
Parul Institute of Ayurved,
Parul University
Limda Post,Waghodia Taluk,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 |
Dr Sachin Deva |
Parul Ayurveda Hospital |
Room no - 106
Dept-Kayachikitsa
Division-Kayachikitsa Vadodara GUJARAT |
9844810957
sachin.deva@paruluniversity.ac.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee for Human Research |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E086||Diabetes mellitus due to underlying condition with other specified complications, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Diagnosed patients of Prameha will be selected with symptoms Prabhoota and Avilamootrata & slight increase in quantity of urine associated with premonitory symptoms and symptoms of DM including Polyurea, Polydipsia, Polyphagia, Lassitude and Weightloss. |
|
ExclusionCriteria |
Details |
Thyroid dysfunctions, patients with cortico steroids therapy & chronic cigarette smokers
Pregnancy with DM
Systemic disorders hampering the kidney functions and other major disorders like TB,IHD,HIV associated with DM
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Relation between duration of Prameha and renal dysfunction with Cystatin-C findings. |
1 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
To analyze the involvement of Mutravaha srotas in Prameha by considering Prabhoota and Availa mutra which signifies reduced GFR. |
6 month |
|
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)
|
01/12/2020 |
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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
In Prameha all the
dravadhatus in reference to kapha from shareera gets excreted through mutra.
There is a significant change in
physical constitution, chemical contents and biochemical properties in such
mutra. The abnormal metabolic admixture of dustadosha, pradushtadhatu with
mutra is nothing but pradusthita mutra or saama mutra. Therefore there is a
extra addition of ama and its constituents to mutra which make mutra turn
avila.
Normal value of GFR is 125ml/min. A stepwise increase in nitrogenous
constituents of blood like urea, creatinine etc and other biochemical
parameters like albumin, electrolytes etc also believed to reflect
deteriorating kidney function.
Renal involvement is a common complication and a leading cause of death
in diabetes which is classified under late systemic complications.
In chirakaaleena Pramehi dhatu excreted out with mutra can be considered
as samala mutrata or saghana mutrata which signifies the reduced GFR by kidneys
landing up in many renal dysfunctions.Since Cystatin-C is a small protein which
is produced constantly, freely filtered by glomerulus and also fully reabsorbed
and broken down by renal tubules is considered as better marker for GFR than
Serum Creatinine.
In this research study the findings of Cystatin-C will help in
understanding the relation between duration of Prameha vyadhi and Renal
dysfunctions occurring in the same which will help in analyzing the involvement
of mutravaha srotas. |