| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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.
|