| CTRI Number |
CTRI/2025/10/095665 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Dhavan & dhupan karma done on infected wound] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Araghvadh and Daruharidra on Dushtavran |
|
Scientific Title of Study
|
Randomized uncontrol clinical trial for combined effect of Aragvadh patra
kashay Dhavan and Daruharidra sukshma churna Dhoopan in treatment of
dushta vrana. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TazimFatema |
| Designation |
Pg scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no. 13 Shalyatantra Department Hon Shri Annasaheb Dange Ayurved Medical College
Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Satara
MAHARASHTRA
415110
India |
| Phone |
8421038609 |
| Fax |
|
| Email |
tazeenkacchi786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Sarjerao Dange |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no. 13 Shalyatantra Department Hon Shri Annasaheb Dange Ayurved Medical College
Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8600600181 |
| Fax |
|
| Email |
drvijaydange@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Sarjerao Dange |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no. 13 Shalyatantra Department Hon Shri Annasaheb Dange Ayurved Medical College
Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8600600181 |
| Fax |
|
| Email |
drvijaydange@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon. Shri. Annasaheb Dange Ayurved Medical College,
Post Graduate & Research Center, Ashta.
Tal-Walwa Dist- Sangli - 416 301(Maharashtra) India. |
|
|
Primary Sponsor
|
| Name |
Hon. Shri. Annasaheb Dange Ayurved Medical College, Post Graduate & Research Center, Ashta. |
| Address |
Hon. Shri. Annasaheb Dange Ayurved Medical College,
Post Graduate & Research Center, Ashta.
Tal-Walwa Dist- Sangli - 416 301(Maharashtra) India. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| TazimFatema |
OPD no 13 ground floor shalyatantra department Hon. Shri. Annasaheb Dange. |
Hon. Shri. Annasaheb Dange Ayurved Medical College,
Post Graduate & Research Center, Ashta.
Tal-Walwa Dist- Sangli - 416 301MaharashtraIndia.
Sangli
MAHARASHTRA |
8421038609
tazeenkacchi786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L08||Infections of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | prakShAlana-karma, प्रक्षालन-कर्म | (Procedure Reference: Sushrut samhita, Procedure details: 1.Firstly Patient is taken to dressing room wound opened ,cleaned dimensions measured 2.Freshly prepared kwatha of aragvadh patra churna is poured on the dushta vrana which should be lukewarm 3.The quantity & duration of kwatha dhavan will be decided based on the size of wound. )
| | 2 | Intervention Arm | Procedure | - | dhUpana, धूपन | (Procedure Reference: Sushrut samhita, Procedure details: After dhavan , Dhoopan will be done with the help of specially designed “Dhoopan Yantra”. Fumes are exposed to wound & duration is decided according to the size of wound , wound scrapped with guaze & dressing done)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Infected wound |
|
| ExclusionCriteria |
| Details |
Patients with systemic disorders,tb ulcers,malignant ulcers |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the Shodhana effect of Araghvadh Patra Kashay Dhavan in
Dushta Vrana .
2.To evaluate the Ropana effect of Daruharidra Sukshma churna Dhoopan in
Dusta Vrana |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study in detail dushta vrana according to ayurveda & modern science |
15 days |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2025 |
| 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
|
Now a day non healing wound is a challenge to a surgeon. Dushtrana are non-healing wound which are difficult to heal and often prone to Infection. According to AcharyaSushruta among the 60 measures of wound treatment, Kashay kalpana (Decoctions) is indicated for non healing wounds located in muscle and having slough.The kashay performs both functions of “Shodhana” (cleaning) and “Ropana” (healing) in Dushta Vrana. Vrana Dhoopan simply means fumigation of vrana with the help of Dhoopan dravya. Dhoopan dravyas are the herbs which produce fumes when heated. These Dhoopan herbs contain volatile substances like oils, tars and resins. When Dhoopan dravyas are provided heat, the volatile ingredients are liberated out to produce dhoopa (fumes) To consider the significance of this method this study is conducting to know the combined effect of Aragvadhpatra dhavan& Daruharidra sukhshma churna Dhoopan in treatment of dushta vrana |