| CTRI Number |
CTRI/2025/07/089951 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of sharapunkha lepa application in Sadyovrana |
|
Scientific Title of Study
|
An open label single arm clinical study to evaluate the Sharapunkha lepa in the management of Sadyovrana. |
| 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 Ashok Kumar S |
| Designation |
PG scholar |
| Affiliation |
Ashwini Ayurvedic Medical College and Research centre |
| Address |
Dept of Shalyatantra, OPD room no.13, Ashwini Ayurvedic Medical College,marlur ring road,marlur, tumkur -572105, Karnataka
Dept of Shalyatantra, OPD room no.13, Ashwini Ayurvedic Medical College,marlur ring road,marlur, tumkur -572105, Karnataka
Tumkur
KARNATAKA
572105
India |
| Phone |
8884772656 |
| Fax |
|
| Email |
drashokgowda183@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharmapal S L |
| Designation |
HOD and Professor |
| Affiliation |
Ashwini Ayurvedic Medical College and Research centre |
| Address |
Dept of Shalyatantra, OPD room no.13, Ashwini Ayurvedic Medical College,marlur ring road,marlur, tumkur -572105, Karnataka
Dept of Shalyatantra, OPD room no.13, Ashwini Ayurvedic Medical College,marlur ring road,marlur, tumkur -572105, Karnataka
Tumkur
KARNATAKA
572105
India |
| Phone |
9916121607 |
| Fax |
|
| Email |
drdharmapal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar S |
| Designation |
PG scholar |
| Affiliation |
Ashwini Ayurvedic Medical College and Research centre |
| Address |
Dept of Shalyatantra, OPD room no.13, Ashwini Ayurvedic Medical College,marlur ring road,marlur, tumkur -572105, Karnataka
Dept of Shalyatantra, OPD room no.13, Ashwini Ayurvedic Medical College,marlur ring road,marlur, tumkur -572105, Karnataka
Tumkur
KARNATAKA
572105
India |
| Phone |
8884772656 |
| Fax |
|
| Email |
drashokgowda183@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ashok Kumar S 1st PG scholar, Dept of Shalyatantra, Ashwini Ayurvedic Medical College and Research centre,marlur ring road, Tumkur572105 Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Ashok Kumar S |
| Address |
Ashwini Ayurvedic Medical College marlur ring road,Tumkuru 572105, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Dharmapal S L |
Ashwini Ayurvedic Medical College marlur ring road,Tumkuru 572105, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ashok Kumar S |
Ashwini Ayurvedic Medical College and Research centre |
Department of Shalyatantra,OPD no.13, MGW D 05,FGW E 05,MGWG 1-9,FGW G 1-9,Ashwini Ayurvedic Medical College,marlur ring road Tumkuru 572105, Karnataka
Tumkur
KARNATAKA |
08884772656
drashokgowda183@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashwini Ayurvedic Medical College Institutional Ethical Committee |
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: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sharpunkha , Reference: Chakradatta, Sadyovrana chikitsa , Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects irrespective of age, sex and occupation.
Sadyovrana upto deep fascia. |
|
| ExclusionCriteria |
| Details |
Sadyovrana with injury to major blood vessels, nerves or vital organs.
Sadyovrana breaching deep fascia.
Wound associated with Fracture.
Wound that require suture.
The subjects having Sadyovrana with complications like Marmaghata.
Medico-legal cases.
Subjects suffering from complicated systemic disorders that which interfere in the line of treatment.
Subjects of known cases like Malignancy, Gangrene, Leprosy, TB wound, HIV, Hepatitis-B. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fast healing of wound |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quick Healthy granulation tissue formation |
10 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="2" |
|
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
|
In ayurveda Vrana is defined as “Vrana Gaatra Vichurnane Vranayateeti Vrana|”1 "Gaatra" means Tissue (body tissue or part of body), "Vichurnane" means destruction, break, rupture and discontinuity of the body tissue. "The destruction / break/ rupture/ discontinuity of the body tissues are called vrana"/wound.2 Injury is the adverse effect of a physical force upon a person and all force involved in injuries is mechanical3. The incidence of wound, trauma is very large globally and a large share of economy is spent annually for the prevention of complications and management of the wound patients.4 Wound healing is the process of repair that follows injury to the skin and other soft tissues.5 There are three stages of wound healing:- Inflammation, Proliferation and Remodeling (Maturation phase).6 A vast description of Vrana and Vranaropaka yogas has been explained in Ayurveda thousands of years ago. Vrana mainly classified into two types7 1. Nijavrana. 2. Agantujavrana. Sadyovrana is mentioned under Agantujavrana. Acharya Sushrutha has given a detailed description of Vrana and its management elaborately described in Susrutha Samhitha, that includes ShastiUpakrama in which, Alepa8 is the 2ndShastiUpakrama. For treatment of Sadyovrana, Chakradatta has mentioned, Sharapunkha lepa, which contains Sharapunkha and Madhu that heals all types of vrana.9 The Sharapunkha drug is also mentioned by Bhavaprakasha in Guduchayadi varga10, Priya nigantu in shatapushpa varga11 and Indian materia medica mentions Sharapunkha (Teprosia purpurea) drug having wound healing property/ Vranaropana.12 For the treatment of Sadyovrana, Acharya Sushrutha has explained application of Madhu (Honey) and Go-gritha for sandanartha.13 Vagbhata acharya described application of Madhu and Grutha after surgical procedure for the Post-operative wounds.14Many therapeutic properties have been attributed to honey including antibacterial activity and the ability to promote healing.15 Both the drugs are easily available and preparation method is easy, economical and can be done in OPD basis. Analyzing their efficacy can be especially relevant and beneficial for communities with limited access to advanced medical resources and it also shedlight on potential synergistic effects. Hence it has been planned to study Sharapunkha lepa clinically on the patients of Sadyovrana. |