| CTRI Number |
CTRI/2024/10/075965 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of shala pratisarniya kshara in dushta vrana (infected wound) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to Evaluate the Shodhana Effect of Shala (Shorea robusta) in Comparison to Apamarga (Achyranthes aspera) Pratisarniya Kshara in Dushta Vrana (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 Anagha Sevakram Hirapure |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Dr d y patil college of ayurved, hospital and research centre, pimpri pune |
| Address |
OPD No 3 And IPD Shalyatantra of Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
8668461276 |
| Fax |
|
| Email |
anaghahirapure0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay C Babar |
| Designation |
M S (Shalyatantra) PhD Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD No 3 And IPD Shalyatantra of Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay C Babar |
| Designation |
M S (Shalyatantra) PhD Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
OPD No 3 And IPD Shalyatantra of Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Anagha Sevakram Hirapure |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 18 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anagha S Hirapure |
Dr D Y Patil College of Ayurved and Research Centre |
OPD No 3 And IPD Shalyatantra of Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA |
8668461276
anaghahirapure0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local 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 | - | vraNadhUpanam, वà¥à¤°à¤£à¤§à¥‚पनमॠ| (Procedure Reference: , Procedure details: (Procedure Reference:,
Procedure details: (Procedure
Reference: Sushruta samhita sutrasthan, Procedure details: Sushruta samhita sutrasthan adhyay 11 shlok 11. There is no any studies on shala pratisarniya kshara karma & hence it is selected for the study. )) dressing will be done daily with applying shala pratisarniya kshara on dushta vrana in an adequate amount & kept for 100 matrakala. Followed by wash with fresh lemon juice & dressing will be closed. The assessment will be done on 1st 3rd 5th & 7th day )
| | 2 | Comparator Arm | Procedure | - | vraNaSoPasyasaptopakramAH, वà¥à¤°à¤£à¤¶à¥‹à¤«à¤¸à¥à¤¯à¤¸à¤ªà¥à¤¤à¥‹à¤ªà¤•à¥à¤°à¤®à¤¾à¤ƒ | (Procedure Reference: , Procedure details: (Procedure Reference:,
Procedure details: (Procedure
Reference: Sushruta samhita sutrasthan, Procedure details: Sushruta samhita sutrasthan adhyay 11 shlok 11. There are various studies on
apamarga pratisarniya kshara
karma & hence it is selected for the study as a comparison. )) dressing will be done daily by applying adequate amount of kshara on dushta vrana & kept for 100 matrakala & washed with fresh lemon juice & dressing will be done followed by assessment done on 1st 3rd 5th & 7th day)
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having any 3 of the following 5 clinical features of Dushta Vrana (Infected wound):
•Strava (Discharge),
•Durgandha (Foul Odour),
•Vedana (Pain),
•Kandu (Itching),
•Varna (Redness).
2.Patients will be selected from an age group of 18–80 years.
3.Postoperative wound with symptoms of Dushta Vrana (Infected wound).
4.Vrana (Wound) size maximum: 5 x 5 cm (Length x Breadth)
|
|
| ExclusionCriteria |
| Details |
1.Patients known case of systemic diseases like Uncontrolled Diabetes Mellitus, Hypertension, and Severe Anemia.
2.The patients with following conditions -
•Malignancy,
•Pregnancy.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the
1.Increased Rate of Desloughing
2.Reduced Infection Severity
3.Improved Wound Healing
4.Decreased Inflammation
5.Enhance Granulation Tissue Formation
6.Prevention of Complications |
Dressing will be done once in a day for 5 to 7 days and assessment will be done on 1st, 3rd, 5th , and 7th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the ropana(healing) property of shala pratisarniya kshara in dushta vrana as compared to apamarga pratisarniya kshara for healing property |
Dressing will be done once in a day for 5 to 7 days & assessment will be done on 1st, 3rd, 5th, & 7th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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
|
“A Randomized Controlled Clinical Study to Evaluate the Shodhana Effect of Shala (Shorea robusta) in Comparison to Apamarga (Achyranthes aspera) Pratisarniya Kshara in Dushta Vrana (Infected Wound)†The current treatment for infected wound involves healing by secondary intention, in references to ancient samhita the use of kshara karma is used to cure the dushta vrana, showing powerful effect and beneficial method for shodhan of infected wound by being an inexpensive and straightforward approach for desloughing of wound and fastening the healing of wound. Kshara also minimize the risk and recurrence while preventing complications. The purpose of study is to enhance the blood circulation in the dushta vrana to avoid further infection. |