| CTRI Number |
CTRI/2025/10/095780 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study The Effect Of kutaj Ghrita In The Management Of Dushta Vrana With Special Reference To Infected Wound |
|
Scientific Title of Study
|
Randomised controlledclinical study to evaluate the shodhan and ropan effect of kutaj ghrita in the management of dushta vrana with special reference to infected wound |
| 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 Shamal Balkrishna Shirale |
| Designation |
PhD Student |
| Affiliation |
LRP Ayurvedic college and research centre urun Islampur |
| Address |
Department of Shalyatantra OPD,OPD no. 4,LRP AYURVEDIC COLLEGE AND RESEARCH CENTRE URUN ISLAMPUR Sangali MAHARASHTRA 415409 India
Sangli
MAHARASHTRA
415409
India |
| Phone |
8237889747 |
| Fax |
|
| Email |
abhidnyapagare007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ramchandra Shedge |
| Designation |
HOD Professor in shalyantantra department |
| Affiliation |
LRPAMCH ISLAMPUR |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room NO 1 Tal Walwa Dist Sangli MAHARASHTRA 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amitshedge12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shamal Balkrishna Shirale |
| Designation |
Ph D Scholar |
| Affiliation |
LRPAMCH ISLAMPUR |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room NO 1 Tal Walwa Dist Sangli MAHARASHTRA 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
8237889747 |
| Fax |
|
| Email |
abhidnyapagare007@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room NO 1 Tal Walwa Dist Sangli MAHARASHTRA 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Shamal Balkrishna Shirale |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room NO 1 Tal Walwa Dist Sangli MAHARASHTRA 415409 |
| 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 SHAMAL SHIRALE |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute And Research Centre Islampur |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room NO 1 Tal Walwa Dist Sangli MAHARASHTRA 415409
Sangli
MAHARASHTRA |
8237889747
abhidnyapagare007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kutaj ghrita, Reference: Sutrastan addhyay38 Dravyasangrahaniyaadhyaya Lakshadigana Shloka65 Page no 304, Route: Topical, Dosage Form: Ghrita, Dose: 2(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: No | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: yashtimadhu ghrita, Reference: Bhavprakash Sri Bhavamisra published by chaukhambasanakrit sansthan Varanasi 5thedi Atha Haritakyadi varga145146, Route: Topical, Dosage Form: Ghrita, Dose: 2(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: No |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of dushta vrana as per ayurvedic literature.
2. Patient of irrespective of gender, caste, religion, sex, occupation are taken.
3. Patient aged between 18-60 years.
14
4. Wound area upto 36 cm2 irrespective of length and breadth will be selected for study. |
|
| ExclusionCriteria |
| Details |
Wound with known case of systemic disorders like HIV, Hepatitis B, known cases of diabetes
mellitus or any other systemic infection.
2. Vrana (wound) very near to vital organs.
3. Ulcer secondary to any malignancy .
4. Patients suffering from wounds like tubercular ulcers.
5. Venous ,arterial ulcers,leprotic ulcers, ulcers with Gangrenous changes .
6. Burn wound,Osteomyelitis, fracture wounds, bed sore. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Kutaj ghrita in the management of Dushta vrana with special reference to infected wound. |
21 days
Application of ghrita on 0th to 15th day
follow up on 18th and 21st. day .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study in detail the litrature of Dushta Vrana to Ayurvedic aspect.
2.To study in detail the litrature of Dushta Vrana to Modern aspect.
3.To Study the concept of Kutaj Ghrita. |
1.To study in detail the litrature of Dushta Vrana to Ayurvedic aspect.
Application of kutaj ghrita on 0 th to 15 th days
Follow up -18th ,21th days
2.To study in detail the litrature of Dushta Vrana to Modern aspect.
3.To Study the concept of Kutaj Ghrita. |
|
|
Target Sample Size
|
Total Sample Size="226"
Sample Size from India="226"
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)
|
20/10/2025 |
| 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="1"
Months="6"
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
|
This is a Randomised controlled clinical study to evaluate the efficacy of Kutaj ghrita in the management of Dushta Vrana with special reference to infected wound.Kutaj ghrita & Yashtimadhu ghrita is varana shodhan, ropan,krimighna,lekhana.The age group for the study will be 18 years to 60 years.Ayurvedic formulation will be given daily for 15 days .Follow up on 18 th & 21 th day.Evaluation of effect of both groups using statistical tools will be done and conclusion will be made.
|