| CTRI Number |
CTRI/2018/11/016321 [Registered on: 12/11/2018] Trial Registered Prospectively |
| Last Modified On: |
10/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Apatarpankar Hetus on Krusha Pramehi (low BMI Diabetic patients) and their Blood Sugar Level |
|
Scientific Title of Study
|
An observational study to evaluate the effects of Apatarpankar Hetus on Krusha Pramehi and Blood Sugar Level |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Advait Murli Menon |
| Designation |
PG Final Year |
| Affiliation |
PDEAs College of Ayurved and Research Center |
| Address |
Pathology laboratory, Ayurved Rugnalay and Sterling Multispeciality Hospital, Sector 27, Pradhikaran, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7875150722 |
| Fax |
|
| Email |
ssadvaitmenon93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ragini Patil |
| Designation |
Principal, HOD Rognidan and vikruti vidnyan department |
| Affiliation |
PDEAs College of Ayurved and Research Center |
| Address |
Pathology laboratory, Ayurved Rugnalay and Sterling Multispeciality Hospital, Sector 27, Pradhikaran, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9423573123 |
| Fax |
|
| Email |
patilragini26@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Advait Murli Menon |
| Designation |
PG Final Year |
| Affiliation |
PDEAs College of Ayurved and Research Center |
| Address |
Pathology laboratory, Ayurved Rugnalay and Sterling Multispeciality Hospital, Sector 27, Pradhikaran, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7875150722 |
| Fax |
|
| Email |
ssadvaitmenon93@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Center, sector 25, Pradhikaran, Nigdi, Pune 44 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Center |
| Address |
Sector 25, Pradhikaran, Nigdi, Pune, 44 |
| 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 Advait Murli Menon |
Pathology laboratory, Room No 115, Ayurved Rugnalay and Sterling Multispeciality Hospital |
Pathology laboratory, Room No 115, Ground Floor, Ayurved Rugnalay and Sterling Multispeciality Hospital, Vitthal Rukmini Road, Sector 27, Pradhikaran, Nigdi, Pune-44
Pune
MAHARASHTRA |
7875150722
ssadvaitmenon93@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having B.M.I less than 18.5
Individuals having FBSL > 125 mg/dl or PPBSL > 200 mg/dl |
|
| ExclusionCriteria |
| Details |
Known case of HIV, Tuberculosis, Hyperthyroidism, Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Descriptive study |
Upadravas of prameha will be assessed in the patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Descriptive study |
lakshanas of Vata Prakopa will be assessed in the patient |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
12/11/2018 |
| 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="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes is growing in a rapid pace around the world. India is harbouring many patients which are diabetic but with low Body Mass Index, which is the concept of Diabetes Paradox. Such patients are prone to more complication and there is high mortality rate in these individuals, however the reason to this is not known. Diabetes is closely related to the concept of prameha explained in Ayurved. Charak specifically describes two types of pramehis in Charak Chikitsasthan as sthoola and krusha pramehis, hence it is quite evident that treatment for both is different one is apatarpan and other is santarpan respectively. The present trend in our society is that once serum glucose levels are found to be a bit high there is unprecedented and sudden cut down of fats, oils, all things which tastes sweet from the diet and overuse of exercise and other methods in a desperate attempt to control BSL. Irrespective of the body type of the patient. it has been proved that incidence of mortality is more in individuals having low BMI with diabetes, this includes the Asian Indian phenotype or the Krusha pramehi. The aim of this research is to identify what effects the present protocol and trend of strenuous exercises, cutting down normal food requirements and haphazard consumption of medications is having on krusha pramehis as a desperate attempt to control objective parameters like BSL. Krusha pramehi’s and their BSL will be observed for effect of apatarpankar hetus. |