| CTRI Number |
CTRI/2025/10/096252 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of ointment in management of foot wound |
|
Scientific Title of Study
|
EVALUATION OF WOUND HEALING EFFECT OF OINTMENT CONTAI 5 PERCENT ESSENTIAL OIL FROM MAMMEA SURIGA BUCH HAM EX ROXB FLOWER BU TREATMENT OF DIABETIC FOOT ULCER A SINGLE ARMED OPEN LABEL CLINICAL STUDY |
| 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 Pradeep Shahjirao Shindhe |
| Designation |
Professor and HOD |
| Affiliation |
KAHER Shri B M K Ayurveda Mahavidyalaya Belagavi |
| Address |
Room number 8
General Shalya OPD
Department of Shalyatantra
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahpur BELAGAVI Karnataka 590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
09986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Shahjirao Shindhe |
| Designation |
Professor and HOD |
| Affiliation |
KAHER Shri B M K Ayurveda Mahavidyalaya Belagavi |
| Address |
Room number 8
General Shalya OPD
Department of Shalyatantra
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahpur BELAGAVI Karnataka 590003 India
KARNATAKA
590003
India |
| Phone |
09986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Shahjirao Shindhe |
| Designation |
Professor and HOD |
| Affiliation |
KAHER Shri B M K Ayurveda Mahavidyalaya Belagavi |
| Address |
Room number 8
General Shalya OPD
Department of Shalyatantra
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahpur BELAGAVI Karnataka 590003 India
KARNATAKA
590003
India |
| Phone |
09986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research National Institutional Traditional Medicine Belagavi |
| Address |
Nehru nagar Belagavi 590003 |
| Type of Sponsor |
Government funding agency |
|
|
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 Pradeep Shahjirao Shindhe |
KAHER Shri B M K Ayurveda Mahavidyalaya Belagavi |
Room number 8
Department of Shalyatantra
General OPD
Belgaum
KARNATAKA |
09986331357
pshindhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E114||Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: ointment of 5% essential oil from Mammea suriga (Buch.-ham. Ex Roxb) flower buds, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of either sex in the age group of 20 to 60 years
2 Patient having DFU classified as per the university of Texas grade 1 and 2 with stage A and B size of 15 to 40 cm2 for a duration of more than one month
3 Patients who voluntarily provide written informed consent and were ready to follow procedures as per the study protocol
4 For DFU patients having either Type II DM with HbA1C of less than 8 with non-healing single or multiple ulcers neuropathic or mild neuro ischemic ulcer
|
|
| ExclusionCriteria |
| Details |
1 Patients with ischemic ulcers Diagnosed Clinically or with Doppler
2 Known cases of severe chronic hepatic or renal disease
3 Known cases of any active malignancy
4 Having history of significant cardiovascular event less than12 weeks prior to recruitment chronic alcoholics or alcohol abuse
5 Patients ECG demonstrating any signs of uncontrolled arrhythmia or acute ischemia
6 Patient with history of tuberculosis contagious infectious disease such as Hepatitis B or C or HIV
7 Patients using any other investigational drug within 1 month prior to recruitment
8 Known hypersensitivity to any of the ingredients used in study drug
9 Pregnant and Lactating females
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Ulcer mean surface areas by graph paper
Assessment of ulcer healing process by Bates Jensen ulcer assessment tool Evaluation of ulcer healing process by clinical examination for evaluation of depth of ulcer undermining ulcer edges necrotic tissue type and amount type and amount of exudates appearance of skin colour around the ulcer peripheral tissue edema peripheral tissue induration granulation of ulcer epithelialization of ulcer will be done on every visit on graded scale on Bates Jensen ulcer assessment tool and will be compared with baseline
|
Baseline day15 day30 day45 day60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of ulcer healing process by digital photographs
|
Baseline day15 day30 day45 day60 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Diabetic Foot
Ulcers DFU chronic nonhealing ulcers generally encountered in clinical practice
DFU has a major longterm impact on the quality of life of diabetics along with
affecting their morbidity and mortality It is one of the major complications due to
long standing Diabetes Mellitus with around 25 percentage of diabetics
developing DFU during their lifetime Individuals with DFU are at a greater risk
of premature death myocardial infarction and fatal stroke Treatment of DFU involves appropriate dressing
antibiotics debridement and if required arterial revascularization Ensuring
healing of DFU at their initial stages with proper debridement cleaning and
dressing prevent them to reach to deeper tissues and avoid the possibility of
amputation
Natural products particularly
those synthesized from traditional medicine which have been explored since
thousands of years are still in use directly or indirectly in the treatment of
a range of diseases Mammea suriga flower buds an endemic tree species of
Western Ghats with traditional importance are used in the traditional practices
in the crude form for the management of cutaneous wounds It is rich in phytochemical
constituents antioxidant anti-inflammatory and antimicrobial potentialities
which helps in wound healing Hence the present investigation focused on wound
healing efficacy of crude EO extracted from flower buds of Mammea suriga
is under taken |