| CTRI Number |
CTRI/2025/08/093820 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Studying the effect of local application of Shodhan Keshari ointment in Diabetic foot ulcer. |
|
Scientific Title of Study
|
Prospective, Open labelled, Randomized,Control clinical study of efficacy of local application of Shodhan Keshari Ointment in the management of Dushtayrana with Special reference to Daibetic 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 |
Dr Avinash Vishnu Bharati |
| Designation |
Ph.D. Scholar |
| Affiliation |
Government Ayurved College, Vajirabad, Nanded |
| Address |
Government Ayurved College,Nanded
Vajirabad Chok, near SP Office, nanded - 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
8551076201 |
| Fax |
|
| Email |
bharti.ayush1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra M. Sonekar |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurved College, Vajirabad, Nanded |
| Address |
Government Ayurved College, Nanded
Vajirabad Chok, Near SP Office, Nanded - 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
9822578033 |
| Fax |
|
| Email |
rajendra19641973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avinash Vishnu Bharati |
| Designation |
Ph.D. Scholar |
| Affiliation |
Government Ayurved College, Vajirabad, Nanded |
| Address |
Government Ayurved College, Nanded
Vajirabad Chok, near SP Office , Nanded - 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
8551076201 |
| Fax |
|
| Email |
bharti.ayush1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College, Vajirabad chok, near S P Office,Nanded.
Pin - 431601
State - Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College Nanded |
| Address |
Vajirabad chok, Near S P Office, Nanded.
Pin - 431601
State - Maharashtra, India |
| 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 |
| Dr Avinash Vishnu Bharati |
Government Ayurved College, Nanded |
Department of Shalyatantra, OPD No. 6 and IPD No. 53
Nanded
MAHARASHTRA |
8551076201
bharti.ayush1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Government Ayurved College, Nanded |
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. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shodhan Keshari Ointment, Reference: Bhayshajya Ratnawali, Vrana Chikitsa Adhyay 30, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: No, Route: NA, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Cadexomer Iodine 0.9% | Drug - Cadexomer Iodine 0.9% Ointment
Route - Local Application on wound.
Dose - as per wound size
Frequency - Once a day Dressing.
Assessments - on every 7th Day.
Total Duration - 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having Dushtavrana w.s.r. to diabetic foot ulcer.
Patient with multiple diabetic foot ulcer.
Patient with maximum ulcer size of 7X7cm. |
|
| ExclusionCriteria |
| Details |
Patient with Hb% lower than 8%.
Patient is having uncontrolled diabetes (HbA1c more than 6.5%) and
other major illness like AIDS, Tuberculosis, Hepatitis B,
Malignancy, Varicose ulcer, Deep vein thrombosis, Arterial ulcer,
Ischemic ulcer, Leprosy, Acute and Chronic renal failure, Jaundice and
cirrhosis of liver.
Patient having elevated PT-INR.
Patient in septicemia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| we will Record wound size and healing of wound on every 7th day and final assessment on 28th day. |
assessment on every 7th day and Final assessment after 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/09/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Early detection and effective management of diabetic foot ulcer can
reduce complications, including amputations and possible mortality. With
regard to treatment, new medicinal options should be useful to heal the ulcer
more quickly than with standard therapies. It is essential that these foot ulcers are treated more effectively than
at present medicine. By this approach, providing adequate and effective
health services are necessary for patients and their families. Most of the
treatment modalities which are available today are costly and some are
affecting quality of life of the patient. So, there is a need of alternative
medicine which is cost effective and easy for the treatment of the patient. |