| CTRI Number |
CTRI/2026/01/100445 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| 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
|
Management of Diabetic ulcer with Ayurvedic medicated lep. |
|
Scientific Title of Study
|
Evauation Of Add On Effect Of Sarivamoola Lep In Dushta Vrana With Special Reference To Diabetic Ulcer RCT |
| 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 Sushant Machhindranath Thorat |
| Designation |
PhD Scholar |
| Affiliation |
Department of shalyatantra, PMTs Ayurveda Mahavidyalaya and shri Eknath Rugnalaya Shevgaon,Ahmadnagar |
| Address |
Department of shalyatantra, PMTs Ayurveda Mahavidyalaya and shri Eknath Rugnalaya Shevgaon Ahmadnagar
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9970211287 |
| Fax |
|
| Email |
sushant.thorat21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumedh Vyanktesh Wasnik |
| Designation |
Professor and HOD |
| Affiliation |
Department of shalyatantra, PMTs Ayurveda Mahavidyalaya and shri Eknath Rugnalaya Shevgaon,Ahmadnagar |
| Address |
Department of shalyatantra,PMTs Ayurveda Mahavidyalaya and shri Eknath Rugnalaya Shevgaon Ahmadnagar
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9822768267 |
| Fax |
|
| Email |
drsumedh.wasnik14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushant Machhindranath Thorat |
| Designation |
PhD Scholar |
| Affiliation |
Department of shalyatantra, PMTs Ayurveda Mahavidyalaya and shri Eknath Rugnalaya Shevgaon Ahmadnagar |
| Address |
Department of shalyatantra,PMTs Ayurveda Mahavidyalaya and shri Eknath Rugnalaya Shevgaon Ahmadnagar
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9970211287 |
| Fax |
|
| Email |
sushant.thorat21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of shalyatantra,PMTs Ayurveda Mahavidyalaya and shri Eknath Rugnalaya Shevgaon Ahmadnagar Maharashtra India Pin-414502 |
|
|
Primary Sponsor
|
| Name |
Dr Sushant Machhindranath Thorat |
| Address |
PMTs Ayurveda Mahavidyalaya and shri Eknath Rugnalaya Shevgaon Ahmadnagar,Maharashtra, India Pin-414502 |
| Type of Sponsor |
Other [(Self)] |
|
|
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 Sushant Machhindranath Thorat |
PMTs Shri Eknath Rugnalaya, Shevgaon |
Department of shalyatantra,PMTs Ayurveda Mahavidyalaya and shri Eknath Rugnalaya Shevgaon Ahmadnagar Pin-414502
Ahmadnagar
MAHARASHTRA |
9970211287
sushant.thorat21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PMT/ACS/IEC/PHD-17 Shalya-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarivamoola Lepa, Reference: Yogratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 0(NA), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 30 Days, Reference: No, Route: -, Dosage Form: Lepa Churna, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Betadine Ointment | betadine ointment application will done once daily |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group Patients from age group of 30 to 60 will be enrolled for the study.
2. Patients having history of Diabetes mellitus for minimum of 3 years & Diabetic ulcer
since 1 month.ulcer size is equal or more than 5 x 5cm
3. Patients having Diabetic ulcer on any part of the body of grade 1 according to Wagner
Meggitt Classification of Diabetic ulcer i.e. having Superficial ulcer involving skin and
subcutaneous tissue.
4. Patients who are ready to take regular oral hypoglycaemics prescribed to them
according to their condition for controlled blood sugar level.
5. Patients who are willing to participate this study voluntarily with their own written
consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients having other than diabetic ulcer.
2. Patients with uncontrolled sugar levels with or without treatment.
3. Patients having diabetic ulcer from grade 2 according to Wagner-Meggitt Classification
of Diabetic ulcer.
4. Patients having other systemic disorders complicating the ulcer like varicose vein,
Squamous cell carcinoma, PVD, Serology positive, Immuno-compressive patient etc.
5. Patients with severe infections having symptoms of septicaemia.
6. Patients not willing to sign consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
ulcer.
To evaluate the add on effect of Sarivamoola Lepa in Dushta Vrana W.S.R. to Diabetic ulcer |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study Dushta vrana and Diabetic ulcer in detail according to ayurved and modern
Science
2. To study Sarivamoola in detail.
3. To study the concept of Lepa kalpana on Vrana.
4. To see any Adverse Drug reaction |
30 days |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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="4"
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
|
A debilitating complication of diabetes mellitus is diabetic ulcer, which leads to
increased overall morbidity in patients. This complication may be prevented, as the inciting
factor is most often minor trauma. Early identification of these cutaneous injuries also can lead
to improved outcomes while decreasing the risk of progression. Patients with diabetes mellitus have a total lifetime risk of a diabetic foot ulcer complication as high as 25 percentage. This
activity reviews the evaluation and management of diabetic ulcers and the role of
interprofessional team members in collaborating to provide well-coordinated care and enhance
patient outcomes. According to the definition of Dushta Vrana, Diabetic ulcer can be corelated easily with
Dushta Vrana. Acharya Sushruta mentioned many therapies for healing of Dushta Vrana. i.e.
for its Shodhana and Ropana also. Therefore, Diabetic wound can be treated as per the
guidelines of Acharya Sushruta given for the healing of Dushta Vrana. In Vrana Shodhana Ropana Vidhi Yogaratnakara stated that Sariva (Hemidesmus
indicus) also known as Anantamula or Ananta root lepa is Sarva vrana vishodhana. Sariva has
Madhura and Tikta Rasa, Madhura Vipaka, Guru and Snigdha guna and Tridoshahara action
mainlt Kapha Pitta hara. Due to its phytochemical constitution, it is Demulcent also. Therefore,
it seems to be helpful for Vrana Shodhana and Ropana.
Therefore, it is of prime interest to observe whether Sarivamoola Kalka Lepa is
effective in Wound healing in diabetic ulcers as it has large prevalence in India. If yes then
how? Hence the topic Evaluation of Add on Effect of Sarivamoola Lep in Dushta Vrana with
Special Reference to Diabetic Ulcer – Rct. Is selected for research. |