| CTRI Number |
CTRI/2024/04/065667 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A descriptive study of assessment of dhatupaka in patients of diabetic foot ulcer |
|
Scientific Title of Study
|
A Descriptive study of association of dhatupaka in patients of diabetic foot ulcer |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant Yashavant Kulkarni |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Rasta peth, Pune. |
| Address |
Rognidan department,Tilak Ayurved Mahavidyalaya, Rasta peth, Pune.Seth Tarachand Ayurvedic charitable hospital,Rasta peth,Pune-411011
Maharashtra
India
Pune
MAHARASHTRA
411011
India |
| Phone |
8975124635 |
| Fax |
|
| Email |
drprashantkulkarni2764@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri Deshpande |
| Designation |
Professor MD PhD Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Rasta peth, Pune. |
| Address |
Rognidan department,Tilak Ayurved Mahavidyalaya, Rasta peth, Pune.Seth Tarachand Ayurvedic charitable hospital,Rasta peth,Pune-411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9960081113 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjiri Deshpande |
| Designation |
Professor MD PhD Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Rasta peth, Pune. |
| Address |
Rognidan department,Tilak Ayurved Mahavidyalaya, Rasta peth, Pune.Seth Tarachand Ayurvedic charitable hospital,Rasta peth,Pune-411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9960081113 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya, Rasta peth, Pune,Maharashtra |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyala |
| Address |
Tilak Ayurved Mahavidyalaya, Rasta peth, Pune-411011
Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrPrashant Kulkarni |
Tilak Ayurved Mahavidyalaya |
Rognidan department,Tilak Ayurved Mahavidyalaya, Rasta peth, Pune.Seth Tarachand Ayurvedic charitable hospital,Rasta peth,Pune-411011
Maharashtra
Pune
MAHARASHTRA |
8975124635
drprashantkulkarni2764@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TILAK AYURVED MAHAVIDYALAYA AND SETH TARACHAND RAMNATH CHARITABLE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: PRAMEHA-PIDAKA, (2) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who diagnosed for diabetic foot ulcers
irrespective of age, sex, marital status, socioeconomic status, race, religion |
|
| ExclusionCriteria |
| Details |
Patients having foot ulcers without diabetes mellitus
Patients suffering from major illness, who needs intensive care |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study association of dhatupaka lakshane in diabetic foot ulcer |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study of status of agni and dhatwagni in patients of diabetic foot ulcer
To study predominantly observed strotas dushti in patients of diabetic foot ulcer. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
20/04/2024 |
| 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="1"
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
|
To study association of dhatupaka in patients of diabetic foot ulcer. To study status of agni and dhatwagni in patients of diabetic foot ulcer To study predominantly observed srotas dushti in patients of diabetic foot ulcer. |