| CTRI Number |
CTRI/2019/10/021525 [Registered on: 03/10/2019] Trial Registered Prospectively |
| Last Modified On: |
01/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Ayurveda and Modern medicine in Diabetic foot ulcer |
|
Scientific Title of Study
|
Effect Of Integrative Approach In The Management Of Diabetic Foot Ulcers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Shindhe |
| Designation |
Reader and HOD, Department of Shalyatantra, KAHER’s Shri B M K Ayurveda Mahavidyalaya |
| Affiliation |
KAHER’s Shri B M K Ayurveda Mahavidyalaya |
| Address |
Reader and HOD, Department of Shalyatantra, KAHER’s Shri B M K Ayurveda Mahavidyalaya, Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Shindhe |
| Designation |
Reader and HOD, Department of Shalyatantra, KAHER’s Shri B M K Ayurveda Mahavidyalaya |
| Affiliation |
KAHER’s Shri B M K Ayurveda Mahavidyalaya |
| Address |
Reader and HOD, Department of Shalyatantra, KAHER’s Shri B M K Ayurveda Mahavidyalaya, Shahapur, Belagavi
KARNATAKA
590003
India |
| Phone |
9986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Shindhe |
| Designation |
Reader and HOD, Department of Shalyatantra, KAHER’s Shri B M K Ayurveda Mahavidyalaya |
| Affiliation |
KAHER’s Shri B M K Ayurveda Mahavidyalaya |
| Address |
Reader and HOD, Department of Shalyatantra, KAHER’s Shri B M K Ayurveda Mahavidyalaya, Shahapur, Belagavi
KARNATAKA
590003
India |
| Phone |
9986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER’s Shri B M K Ayurveda Mahavidyalaya |
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
| Address |
KAHER’s Shri B M K Ayurveda Mahavidyalaya, Shahapur, Belagavi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep Shindhe |
KLE Ayurveda Hospital |
OPD No 08 and IPD of KLE Ayurveda Hospital Shahapur Belagavi
Belgaum
KARNATAKA |
9986331357
pshindhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E136||Other specified diabetes mellituswith other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Treatment |
Systemic treatment –IV fluids, Antibiotics, Analgesics, anti- diabetic drugs and debridement if required.
Local treatment-Daily dressing with povidone iodine,H2O2and EUSOL solution once daily.
DRUGS WILL BE SELECTED AS PER THE CONDITION OF THE PATIENT
|
| Intervention |
Integrated Treatment |
Systemic treatment –Follows the integrated protocol i.eIV fluids, Antibiotics, Analgesics, anti- diabetic drugs and debridement if required along with Shodhana and shamana line of treatment will be planned according to the Dosha, Dushya, Desha, Bala, Kala, Avastha, Satva and satmya of the patient
Local treatment-Daily dressing with according to Avastha of the wound ieDushtavrana or shuddhavrana. In case of dust vrana the following procedures will be carried out till the wound shows shuddha vrana laxanas ie Prakshalana, Dhupan, pichu, Raktamokshana etc are adopted. Once wound shows shuddha vrana laxana ropan line of management will be adopted with Siddha ghruta and Taila.
DRUGS WILL BE SELECTED AS PER THE CONDITION |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients with diabetes mellitus suffering from foot ulcers and infections of all age groups,
Incidental diagnosis of diabetes on admission with diabetic foot ulcer
Patients with gangrenous foot, complicated by diabetes are included in the study.
Grading 0-4 of diabetic foot ulcers by Wagner-Meggitt Classification
|
|
| ExclusionCriteria |
| Details |
Patients with foot infections without diabetes mellitus,
Patients with gangrene foot of etiology other than infection of foot, complicated by diabetes
Patients whose treatment could not be completed
Grading 5 of diabetic foot ulcers by Wagner-Meggitt Classification
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Wound healing [ Time Frame: 4weeks ] wound closure
Major amputation prevented above the knee, below the knee
Minor amputation with preservation of ambulation , toe amputation, transmetatarsal amputation.
|
0th, 7th, 14th, 21st, 28th, 29th, 30th, 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/12/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Integrated
care is a concept bringing comprehensive inputs, delivery, management and
organization of services related to diagnosis, treatment, care, rehabilitation
and health promotion and keeping the objective to overcome the ambiguities of
each health care disciplines and to shoulder one another to give comprehensive
patient care.
Diabetic
foot
ulcer is challenging for treatment, because of multiple factors and infection
is being one among it. Hence the management of DFU requires a multifactorial
approach.
To
fulfil,
this needs we took a step ahead and collaborated Ayurveda and Modern medicine
to render effective integrated DFU management. |