FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070065 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Analytical 
Study Design  Other 
Public Title of Study   Study of premonitoring symptoms of Madhumeha in Pre Diabetes and Diabetes Mellitus. 
Scientific Title of Study   A Cross Sectional Analytical Study To Evaluate the Purvarupa of Prameha in Pre Diabetes and Diabetes Mellitus 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Gamaji Paikrao 
Designation  Assistant Professor  
Affiliation  APMs Ayurved Mahavidyalaya and Hospital  
Address  Dept. of Rognidan and Vikriti Vigyan, Second floor, APMS Ayurved Mahavidyalaya, Near Sion Rly Station, Sion, Mumbai(MS)
Dept of Rognidan and vikriti Vigyan, Second floor, APMS Ayurved Mahavidyalaya and Hospital, Near Sion Railway station, Sion, Mumbai (MS) 400022
Mumbai
MAHARASHTRA
400022
India 
Phone  9082493197  
Fax    
Email  drsanjaygp@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Arun Shankarrao Dudhamal 
Designation  HOD and Asso Professor  
Affiliation  APMs Ayurved Mahavidyalaya 
Address  Dept of Rognidan and Vikriti Vigyan, Second floor, APMS Ayurved Mahavidyalaya, Near Sion Rly Station, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9664340199  
Fax    
Email  asdudhamal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Gamaji Paikrao 
Designation  Assistant Professor  
Affiliation  APMs Ayurved Mahavidyalaya 
Address  Dept of Rognidan and Vikriti Vigyan, Second floor, APMS Ayurved Mahavidyalaya, Near Sion Rly Station, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9082493197  
Fax    
Email  drsanjaygp@rediffmail.com  
 
Source of Monetary or Material Support  
APMS Ayurved Mahavidyalaya and Seth RV Charitable Hospital Sion Mumbai 22 
 
Primary Sponsor  
Name  Dr Sanjay Gamaji Paikrao 
Address  APM Ayurved Mahavidyalaya Near Sion Rly Station Sion Mumbai 400022 Maharashtra  
Type of Sponsor  Other [Self ] 
 
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 Sanjay Paikrao  APMS Ayurved Mahavidyalaya & Hospital   Room No 10, OPD Section & Dept of Rognidan, APMS Ayurved Hospital,Sion, Mumbai
Mumbai
MAHARASHTRA 		 9922577551

drpaikrao@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
APMS Ayurved Mahavidyalaya Institutional Ethical Commiittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R739||Hyperglycemia, unspecified. 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  1.Diagnosed Patients of prediabetes and diabetes Mellitus type 2 with
2.IFG( Impaired fasting glucose)BSL fasting More than 100 Mg/dl
3.IGT (Impaired glucose tolerance ) BSL PP More than 140 mg/dl
4.Oral glucose tolerance (0GTT) after 2 hr more than 140
5 HbA1c more than 5.7 %
 
 
ExclusionCriteria 
Details  1.Pre Diabetes, diabetes mellitus patients in pregnant women
2.patients below 18 and mote than 70
3.Patients suffering from major illness like HIV HBV
4.Non cooperative patients  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-Urine Sugar fasting
-Urine sugar PP
-Blood sugar level fasting
-Blood sugar level PP
-HbA1c
 		 8 days  
 
Secondary Outcome  
Outcome  TimePoints 
-Indian Diabetes Risk Score (IDRS)
Features of Prameha Purvarupa
-Hridaye Netra Jivha Shravanopdeha
-Ghan Angata
-Kesha Ativridhi
-Nakha Ativridhi
-Mutre Pippilika Abhisaran
-Shareer Pippilika Abhisaran
-Kesha Jatil bhava
-Kaya chidreshupdeha
-Suptata Angeshu
-Shatpada Abhisarana on Mutra
-Shatpada Abhisarana on Shareer
-Mala kaye
-Mutrech Mutra dosha
-Shwas dorgandhya
-Shukla Mutrata
-Snigdha Gatrata
-Picchil Gatrata
-Pippasa Ativridhi
-Karapada Daha
-Shitilangata
-karapada suptata
-Dantadina Maladyatva
-Sarvanga daha
-Ati sweda pravruti
-Madhurasyata
-Alasya
-Atinidra
-Gala talu Mukha shosha
-Madhur Mutrata

-Asymptomatic
-Polyurea
-Polyphagia
-Polydepsia
-wt.loss
-Blurring vision
-Pruritis
-Nocturia
-fatigue 		 one day  
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   02/09/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Title: A Cross Sectional Analytical Study To Evaluate the Purvarupa of Prameha in Pre Diabetes and Diabetes Mellitus.

Prameha is a chronic life style disease explained in Ayurved by Acharya Charaka 1000 BC, if it is not diagnosed in early stage and not properly treated then all types of Prameha (20types) ultimately morph into madhumeh which is incurable disease and can be produces serious complications in different parts of the body.            Some studies show the purvarupa of prameha (prodromal features) are associated with pre diabetes and some studies shows prameha purvarupa are related with diabetes. This study will help to find the actual association among them.

 

Patients diagnosed with pre diabetes or diabetes mellitus and fulfilling inclusive criteria will be selected and divided in to two group, Group 1 pre Diabetes (80) & group 2 Diabetes (80)with appropriate sample size. Then the patients in each group will be examined for  prameha purvarupa with objective parameters and subjective parameters and data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. Descriptive statistics like frequency (n) &percentage (%) of categorical data, mean & Standard deviation of numerical data in each group / subgroup will be depicted.  Frequency (n) & percentage (%) of various categories in each group / sub group  will be compared using chi square test. Odds ratio, likelihood ratios & chi square test to check the association between the risk factor and disease. Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.

 

With statistical analysis conclusion will be made that whether the Prameha purvavsta is associated with pre diabetes or diabetes mellitus. Clinically it is difficult to diagnose a Prameha in Purvrupavastha due to subjective prodromal features explained in Ayurved samhitas. If we could find the association of  Purvrupa of Prameha with pre diabetes or diabetes mellitus, with the help of laboratory investigations, we may able to diagnose a purvarupavstha of Prameha timely. It will help us to treat Prameha patients in a prodromal state of the disease, it will guide us to suggest the preventive aspect of the disease and thus this study will help us to avoid premeha updravas (complications).

 

 
Close