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CTRI Number  CTRI/2022/11/047190 [Registered on: 10/11/2022] Trial Registered Prospectively
Last Modified On: 28/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Association of warning signs of prameha with signs of prediabetes. 
Scientific Title of Study   Association of prameha poorvaroopa in prediabetes – Cohort study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana Arun Kulkarni 
Designation  Ph.D Scholar  
Affiliation  Tilak Ayurved Mahavidyalaya  
Address  Rog nidan department Tilak Ayurved Mahavidyalaya 583 2 Jagtap Road Rasta Peth Pune Maharashtra 411011 India

Pune
MAHARASHTRA
411011
India 
Phone  9422164367  
Fax    
Email  archana.arukulkarni@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjiri S Deshpande 
Designation  Professor 
Affiliation  Tilak Ayurved Mahavidyalaya  
Address  Rog Nidan department Tilak Ayurved Mahavidyalaya 583 2 Jagtap Road Rasta Peth Pune Maharashtra 411011 India

Pune
MAHARASHTRA
411011
India 
Phone  9960081113  
Fax    
Email  drmanjirideshpande24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manjiri S Deshpande 
Designation  Professor 
Affiliation  Tilak Ayurved Mahavidyalaya  
Address  Rog Nidan Department Tilak Ayurved Mahavidyalaya 583 2 Jagtap Road Rasta Peth Pune Maharashtra 411011 India

Pune
MAHARASHTRA
411011
India 
Phone  9960081113  
Fax    
Email  drmanjirideshpande24@gmail.com  
 
Source of Monetary or Material Support  
Tilak Ayurved Mahavidyalaya 583 2 Jagtap road Rasta Peth Pune 
 
Primary Sponsor  
Name  Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya 583 2 Jagtap Road Rasta Peth Pune 411011 
Type of Sponsor  Government 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 
Archana Arun Kulkarni  Seth Tarachand Ramnath Charitable Ayurved Hospital   OPD of Tilak Ayurved Mahavidyalaya 583 2 Jagtap Road Rasta Peth Pune 411011
Pune
MAHARASHTRA 
9422164367

archana.arukulkarni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: PRAMEHA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients full filling the Laboratory and Clinical screening parameters and diagnosed as prediabetes. 
 
ExclusionCriteria 
Details  Diagnosed patients of Type I or Type II diabetes, Gestational Diabetes mellitus, Diabetes insipidus. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study association between Prameha poorvaroopa and prediabetes  assessment on every 6 month for 2 and 1/2 year
 
 
Secondary Outcome  
Outcome  TimePoints 
To study association between Prameha poorvaroopa and Anthropometric measurements in prediabetes.
To observe the possible effects of early diagnosis of prediabetic status in terms of prevention, aggression and complications of disease. 
assessment on every 6 month for 2 and 1/2 year  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   10/11/2022 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
Not yet done 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Current study is a cohort study to find an association between sings and symptoms of prameha poorvaroopa and prediabetes. Patients diagnosed with HbA1C between 5.4 % to 6.7% will be enrolled.
Total 200 patients will be observed for the period of two and half years. Six monthly  total 4 follow ups will be conducted. Sign and symptoms of the patients and laboratory investigations will be assessed.
                                                     It has been predicted that more than 360 million individuals will have diabetes by the year 2030. The prevalence of type 2 DM is rising at an alarming rate. 
This is predominantly because of increasing obesity and reduced physical activity in developing nations. It is estimated that every year a further 7 million people develop diabetes. 
Symptoms such as increased fluid intake, thirst, dry mouth, itching of the skin, burning sensation of soles, numbness of the toes, paresthesia, and blurred vision may appear in prediabetic patients.[
                                                     Poorvaroopa of prameha are mentioned comprehensively in Ayurvedic text while only two samamya roopas of prameha are mentioned in the classics.
It is clear that poorvaroopas are given more importance. Poorvaroopa of prameha include pipasa (increased fluid intake, thirst), talu shosha or kantha shosha (dry mouth), Kara pada supata (numbness of the toes),
supatata angeshu (paresthesis), karapada daha (burning sensation of soles) along with other poorvaroopa. Therefore, this topic has been selected with curiosity to study the association of prameha poorvaroopa in prediabetic patients.

 
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