| CTRI Number |
CTRI/2025/02/080097 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study Of Vacha Churn Avachurnan In Dushtavran |
|
Scientific Title of Study
|
OPEN RANDOMIZED CLINICAL CONTROL TRIAL OF VACHA CHURN AVACHURNAN IN TREATMENT OF DUSHTAVRAN |
| 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 Divya Patil |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
OPD No 13 Shalya Tantra Department Hon Shri Annasaheb Dange
Ayurved Medical College Post Graduate And Research Center Ashta
Tal Walwa Dist Sangli Maharashtra 416301 India
Sangli
MAHARASHTRA
416301
INDIA
Sangli
MAHARASHTRA
416301
India |
| Phone |
8275660709 |
| Fax |
|
| Email |
divyadpatil99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijy Dange |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center |
| Address |
OPD NO 13 Shalya Tantra Department Hon Shri Annasaheb Dange
Ayurved Medical College Post Graduate And Research Center Ashta
Tal Walwa Dist Sangli Maharashtra 416301 India
Sangli
MAHARASHTRA
416301
INDIA
Sangli
MAHARASHTRA
416301
India |
| Phone |
8600600181 |
| Fax |
|
| Email |
drvijaydange@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Dange |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Cente |
| Address |
OPD No 13 Department of Shalya Tantra Hon Shri Annasaheb
Dange Ayurved Medical College Post Graduate And Research
Center Ashta Tal Walwa Dist Sangli Maharashtra 416301 India
Sangli
MAHARASHTRA
416301
India
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 And Research Center
Ashta Tal walva Dist Sangli State Maharashtra Country India 416301 |
|
|
Primary Sponsor
|
| Name |
Hon shri Annasaheb Dange Ayurved Medical College Post graduate and research center Ashta |
| Address |
Hon shri Annasaheb Dange Ayurved Medical College Post graduate
and research center Ashta Tal Walwa Dist Sangli State Maharashtra
Country India Pin code 416301 |
| 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 |
| Dr Divya Patil |
Hon Shri Annasaheb Dange Ayurved Medical COllege Post Graduate And Research Center Ashta |
OPD No 13 Department
Of Shalya Tantra Hon
Shri Annasaheb Dange
Ayurved Medical
COllege Post Graduate
And Research Center
Ashta 416301
Sangli
MAHARASHTRA
Sangli
MAHARASHTRA |
8275660709
divyadpatil99@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 Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, (2) 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 | - | avacUrNan , अवचूर्णन | (Procedure Reference: Sushrut samhita, Procedure details: 1 Consent was takes
2 Things essential for the procedure were kept ready
3 Patient was made to sit lie down comfortably
4 The affected part cleaned with Normal saline debridement will done where ever necessary & again ulcer will cleaned with normal saline & part dried
5 After cleaning the part & drying it thoroughly Avachurnan of Vacha churna will done once daily preferably in the morning over the entire surface of floor of ulcer
6 A sterile gauze sprinkled with the same powder was placed over the ulcer
7 After avachurana karma the affected part was covered with sterile pad & bandaging will done)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Oxum spray | Composition
Oxidised water
Hypochlorus acid
Oxum Spray is a super oxidized solution for local application
It is intended for use in the debridement and irrigation of acute and chronic wounds ulcers |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Subject with Lakshanas of Dushta Vrana
2 Post operative abscess wound.
3 Wound size 5 7 sqcm in length in breadth
4 Depth of wound upto 1cm |
|
| ExclusionCriteria |
| Details |
1 Patient with known history of HIV HBSAG Tuberculosis or any other systemic disease
2 Malignant ulcer
3 Patient with burn
4 DushtaVranaon Head neck region
5 Features showing gangren |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the shodhan effect of vachachurnaavachurnan in treatment of dushtavarana |
1st, 3rd, 5th, 7th, 9th, 11th, 13th, 15th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare Vachachurnaavachurnan with Oxum spray in treatment dushtavrana |
1st, 3rd, 5th, 7th, 9th, 11th, 13th, 15th |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
10/02/2025 |
| 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
|
Now a day non healing wound is a challenge to a surgeon. Dushtvrana are non-healing wound which are difficult to heal and often prone to infection. According to AcharyaSushruta among the 60 measures of wound treatment, "AVACHURNAN" is indicated for non-healing wounds which are superficial, foul smell and having sloug. The avachurnanperforms functions of "Shodhana" (cleaning) in DushtaVrana and not much work hase been done on avachurnan. AacharyaSushrut mentioned vacha as shodhan churn in sutrasthan and there is no work done on vacha churn’s effect on dushtvran. To consider the significance of this method this study is conducting to study the effectiveness of vacha churn avachurnan in dushtavrana |