| CTRI Number |
CTRI/2025/03/083671 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate The Efficacy Of Patolyadi Lepa In The Management Of Dushta Vrana With Special Reference To Infected Wound. |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study To Evaluate The Efficacy Of Patolyadi Lepa In Management Of Dushta Vrana With Special Refence To Infected Wound. |
| Trial Acronym |
no |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akash Gautam Telgote |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
Shalyatantra OPD And IPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9987757839 |
| Fax |
|
| Email |
akashtelgote1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangini Suresh Nagaralmath |
| Designation |
Associate Professor |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
Shalyatantra OPD And IPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist Sangli 415409 Maharashtra India
Sangli
MAHARASHTRA
415409
India |
| Phone |
09309823311 |
| Fax |
|
| Email |
shubhasn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash Gautam Telgote |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
Shalyatantra OPD And IPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9987757839 |
| Fax |
|
| Email |
akashtelgote1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist Sangli 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Akash Gautam Telgote |
| Address |
Shalyatantra OPD And IPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Dist Sangli 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 Akash Gautam Telgote |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
Department Of Shalyatantra Divison No 1 Room No 1
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur
Sangli
MAHARASHTRA |
9987757839
akashtelgote1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur |
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 | Procedure | - | lepa, लेप | (Procedure Reference: Ashtang Hrudayam Uttarsthan 25/43, Procedure details: purakarma consent taken and prakshalan done with saline
pradhan karma application of the lepa
pashchat karma dressing and bandaging )
(1) Medicine Name: Patolyadi Lepa , Reference: ashtang hrudayam uttartantra 25/43, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 26 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: bhaishajya ratnavali 49/31, Procedure details: purakarma consent taken & prakshalan done with saline pradhan karma application of the tilkastak lepa pashchat karma dressing & bandaging )
(1) Medicine Name: tilkastak lepa , Reference: bhaishajya ratnavali 49/31, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 10(g), Frequency: od, Duration: 26 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients can vary in age from 18 to 60 years.
2.Patient of Irrespective of Gender,caste,religion, sex,occupation are taken.
3. Vrana which are restricted to localised area.
4.Patient having sign and symptoms of Dushtavrana having area Length 5cm x Breadth 5cm x Depth 5mm less will be randomly selected
5.Vrana, which are not secondary to systemic diseases. |
|
| ExclusionCriteria |
| Details |
1.Diagnosed patients of known case of systemic illeness Diabetic wounds, Gangrenous wounds etc.
2.Vrana (wound) very near to vital organs (Heart , brain lung etc.)
3.Patients having immune compressive disease like HbsAg,AIDS or HIV syndrome,DM,HepatitisB,TB,Anemia.etc.
4.Patients having bleeding disorder.
5.Ulcer secondary to any malignancy and Burn wound, Osteomyelitis,Patients suffering from wounds like Tubercular Ulcers, Venous Ulcers Leprotic Ulcers, Malignant Ulcers, Ulcers with gangrenous changes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study The Efficacy Of Patolyadi Lepa In The Management Of Dushta Vrana With Special Referance To Infected Wound. |
Application Of Patolyadi Lepa on 0th,2nd,4th,6th,8th,10th,12th,14th Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study in detail the literature about Dushta vrana according to ayurvedic aspect.
2.To study infected wound in details according to modern aspect.
3.To Prepare Patolyadi Lepa. |
Appilication Of Patolyadi Lepa On 0th,2nd,4th,6th,8th,10th,12th,14th,20th And 26th Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/04/2025 |
| 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="0"
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
|
The Main Aim Of This Randomised Controlled Clinical Study Is To Evaluate The Efficacy Of Patolyadi Lepa In Dushtavranah. Patients Will Be Informed Prior And Consent Will Be Taken. Total 60 Patients For The Study Will Be Taken. Puti (foul aroma), Puya (Pus), Strava (discharge), and Chronocity are
the features of the Dushtavrana, which are associated to wounds that do not
heal,Hence the basic management Of Patolyadi Lepa concept runs through Vedanashamaka, Shothahara, Raktasthambaka Aushdhi prayog, Ropan karma, Shodhan karma, Pathya – apathya prayoga.
|