| CTRI Number |
CTRI/2025/03/081982 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [lepa chikitsa] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Check Efficacy Of Shushvipatra Lepa With Madhu In The Management Of Dushta vrana with special reference to infected wound. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study Of Shushvipatra Lepa With Madhu 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 Ashlesha Arjun Mane |
| Designation |
PG Scholer |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amaravati |
| Address |
OPD No.22 Shalyatantra Department,Vidarbha Ayurved
Mahavidyalaya and Hospital,Dhanvantari Nagar,Amravati
Amravati
MAHARASHTRA
Amravati
MAHARASHTRA
444605
India |
| Phone |
08554984256 |
| Fax |
|
| Email |
ashleshamane8554@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha S Kalmegh |
| Designation |
Guide and HOD Of Shalyatantra Department |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amaravati |
| Address |
Vidarbha Ayurved Mahavidyalaya and Hospital,Dhanvantari Nagar,Amravati
MAHARASHTRA
Amravati
MAHARASHTRA
444605
India |
| Phone |
9422155851 |
| Fax |
|
| Email |
manjushakalmegh75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashlesha Arjun Mane |
| Designation |
PG Scholer |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya Amaravati |
| Address |
OPD No.22 Shalyatantra Department,Vidarbha Ayurved
Mahavidyalaya and Hospital,Dhanvantari Nagar,Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
08554984256 |
| Fax |
|
| Email |
ashleshamane8554@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbh Ayurved college amaravati |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurved Mahavidyalaya , Dhanvantari Nagar,Amaravati, 444605 |
| Address |
Vidarbh Ayurved Mahavidyalaya and Hospital,Dastur Nagar Amaravati,444605, India |
| 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 Ashlesha Arjun Mane |
Vidarbha Ayurved Mahavidyalaya and Hospital, Dhanvantari Nagar, Amravati 444605, India |
OPD No 22 Shalyatantra Department Vidarbha Ayurved college dastur nagar amaravati 444605,India
Amravati
MAHARASHTRA |
08554984256
ashleshamane8554@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.H.V.P.M. Vidarbha ayurved Mahavidyalaya, Amaravati |
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: Sushrut Samhita Sutra sthan 18, Procedure details: Before Application Of Lep Romshatan will be done in patients.On first day at
morning, Shushvipatra Lepa will be applied over wound surface and wound would
be closed by protective covering.
Dose: as per wound size (at morning)
)
(1) Medicine Name: Shushvipatra lepa , Reference: Chakradatta Vranashodha Chikitsa Adhyay , Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: od, Duration: 45 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Metrogel -p ointment | Wound cleaned by normal saline and Metrogyl-P ointment is applied over wound.
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who agree to participate in the trial
2.Patient With all type of dushta vrana with maximum history of more than 2 weeks and less than one month
3.Patients with clinical characteristics of agantuja vrana and nija such as edema, discomfort, burning sensation, pus discharge, and bad smell will be chosen for further study
4.Wound size above 5×5 cm will be selected |
|
| ExclusionCriteria |
| Details |
1.The patient who has underlying bony lesions
2.Patients with Malignant Ulcer.
3.Tuberculous Ulcer.
4.Lepromatous Ulcer.
5.HIV, HbSAg positive patients.
6.Bleeding disorders.
7.Gangrenous wound.
8.Diabetic Wound will not be selected.
9.Animal Bite Injuries.
10.Delicate organs injuries. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete Improvement From Dushta Vrana
Marked Improvement From Dushta Vrana
Mild Improvement From Dushta Vrana |
0,3,7,10,14,17,20,24,28,31,35,38,42,45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Remission From All Kinds Of Dushta Vrana |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/03/2025 |
| 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) |
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 Randomized comparative clinical trial Will be conducted to study the effectiveness of shushvipatra lepa with Madhu in the management of dushta vrana with special reference to the Infected Wound. The trial will be conducted in our institute and its periphery. Total 70 patients diagnosed with dushta vrana will be selected and then will be divided in two groups.
One group will be advised for Shushvipatra lepa with Madhu and other will be advised for metrogel-p ointment application
The study will be done in 45 days. The result will be compared in two groups. Data analysis will be done by using appropriate statistical test. Primary outcomes will be to study the effectiveness of shushvipatra lepa with Madhu in the management of dushta vrana with special reference of Infected Wound
|