| CTRI Number |
CTRI/2025/05/087017 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the effect of ointment made from Surangi flower buds for healing Diabetic Foot Ulcers |
|
Scientific Title of Study
|
Efficacy and safety of ointment containing 5% essential oil from Mammea suriga (Buch.- Ham. ex Roxb.) Kosterm. flower buds in treatment of diabetic foot ulcers: A multicentric parallel group randomized controlled trial |
| 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 Harsha Hegde |
| Designation |
Scientist F |
| Affiliation |
ICMR National Institute of Traditional Medicine Belagavi |
| Address |
N210, 2nd floor, Block 1, Department of Ethnomedicine, ICMR National Institute of Traditional Medicine, Opp KLE campus, Nehrunagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08312439220 |
| Fax |
|
| Email |
harshah@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Barvaliya |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute of Traditional Medicine Belagavi |
| Address |
W309, 3rd floor, Block 1, Department of Health Systems Research, ICMR National Institute of Traditional Medicine, Opp KLE campus, Nehrunagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08312439234 |
| Fax |
|
| Email |
barvaliya.m@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsha Hegde |
| Designation |
Scientist F |
| Affiliation |
ICMR National Institute of Traditional Medicine Belagavi |
| Address |
N210, 2nd floor, Block 1, Department of Ethnomedicine, ICMR National Institute of Traditional Medicine, Opp KLE campus, Nehrunagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08312439220 |
| Fax |
|
| Email |
harshah@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Ansari Nagar New Delhi 110029 India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ketan Vagholkar |
DY Patil Deemed to be University School of Medicine |
Room No. 32, Ground floor, Dept. of General Surgery, Sector 5, Nerul, Navi Mumbai - 400706
Mumbai (Suburban)
MAHARASHTRA |
9821341290
kvagholkar@yahoo.com |
| Dr Raju Shinde |
Jawaharlal Nehru Medical College |
Room No. 3, Ground floor, Dept. of General Surgery, DMIHER, Sawangi (Meghe), Wardha - 442107
Wardha
MAHARASHTRA |
8087148087
raju.shinde95@gmail.com |
| Dr V A Kothiwale |
KLEs Dr. Prabhakar Kore Hospital and MRC |
OPD No. 4, Ground floor, Dept. of General Medicine, JNMC KLE University campus, Nehru Nagar, Belagavi, Karnataka, 590010
Belgaum
KARNATAKA |
9448119899
nov10kothiwale@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IEC KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH,D.Y.PATIL SCHOOL OF MEDICINE, NAVI-MUMBAI |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE OF DMIHER |
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 | Comparator Arm (Non Ayurveda) | | - | Standard dressing | For non-infected ulcers, standard dressing will be done with sterile saline gauze pads and moisturizing agents daily morning for 8 weeks or till complete healing. For mild infected ulcers, betadine ointment will be used in addition with the dressing and specific sensitive oral antibiotics will be given based on the culture and sensitivity report. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Mammea suriga essential oil ointment (5%), Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: For mild infected ulcers, betadine ointment will be used in addition with the dressing and specific sensitive oral antibiotics will be given based on the culture and sensitivity report. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients with age between 18 to 70 years
2. Clinically diagnosed diabetes (HbA1c greater than 6.5 %) and with diabetic foot ulcers as per University of Texas Grade 1 or 2 with stage A or B and size between 15 to 40 cm2
3. Uninfected Diabetic foot ulcers or Diabetic foot ulcers with mild infection as per International Working Group on the Diabetic Foot (IWGDF) and Infectious Disease Society of America (IDSA) (Matilde Monteiro-Soares et al. 2019)
4. Diabetic foot ulcers less than 2 weeks old at the time of screening
5. Willing to give consent for participating in the study |
|
| ExclusionCriteria |
| Details |
1. Patients with necrosis, purulence, or sinus tracts in the target ulcer not removable by debridement
2. Compromised blood flow as indicated by USG colour Doppler report for the affected limbs anterior tibial, posterior tibial, and dorsalis pedis arteries which the treating physician feels may affect the ulcer healing
3. Patients undergone prior amputation due to diabetic wounds
4. HbA1c greater than 12%
5. Patients on regular medicines which may affect wound healing (corticosteroids, immunosuppressive drugs, cancer chemotherapy, NSAIDs, anticoagulants and anticonvulsant drugs)
6. Pregnant and lactating women
7. Any condition which in the opinion of the investigator will place the subject at risk or will influence the conduct of the study or interpretation of results |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy: Proportion of participants achieving complete healing |
4 week
6 week
8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in ulcer size (surface area) |
Baseline
1 week
2 week
4 week
6 week
8 week |
| Quality of life using WHO QoL-BREF questionnaire |
Baseline
8 week |
| Safety: Adverse events for Safety outcomes at any follow-up, infection rate of ulcer |
1 week
2 week
4 week
6 week
8 week |
|
|
Target Sample Size
|
Total Sample Size="308"
Sample Size from India="308"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="2"
Months="6"
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
|
Patients seeking treatment at the Medicine/Surgery OPD at 3 selected hospitals, aged 18-70 years with clinically diagnosed diabetes (HbA1c > 6.5%) having diabetic foot ulcers as per University of Texas Grade 1 or 2 with stage A or B and size between 15 to 40 cm2 will be subjected to detailed screening. Consecutive patients fulfilling the inclusion/exclusion criteria will be enrolled for the study after obtaining written informed consent, and randomly assigned to one of two groups in a 1:1 ratio using computer-generated random sequences. The control group will receive standard dressing with sterile saline gauze pads with moisturizing agents topically, daily morning for 8 weeks or till complete healing. The intervention group will receive dressing with an ointment containing M. suriga EO (5%), daily morning for 8 weeks or till complete healing, whichever is earlier. For mild infected ulcers, betadine ointment will be used in addition with the dressing and oral antibiotics will be given based on the culture and sensitivity report in both the groups. Participants will be followed up weekly at week 1, 2, 4, 6 and 8. At all follow-up visits, ulcer size will be evaluated whereas complete healing will be evaluated at week 4, 6 and 8. HbA1c testing will be done at week 6 and 8. Quality of life assessment will be done using WHO-QoL-BREF at the baseline and end of the study.
Hypothesis - Application of M. suriga EO ointment results in complete healing of a larger proportion of diabetic foot ulcers as compared to standard dressing. |