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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.

 
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