| CTRI Number |
CTRI/2022/12/048541 [Registered on: 27/12/2022] Trial Registered Prospectively |
| Last Modified On: |
23/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate the effect of local ayurvedic application in the treatment of infected wound. |
|
Scientific Title of Study
|
Randomised controlled clinical trial to compare the efficacy of madhuyukt sharpunkha choorna lep with betadine ointment in the management of dushta vrana. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Dattatray Kathole |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Pune |
| Address |
Dept.Of Shalyatantra,Tilak Ayurved Mahavidyalaya,Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7350984369 |
| Fax |
|
| Email |
sagarkathole3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin D Nalawade |
| Designation |
Associate Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Pune |
| Address |
Dept.Of Shalyatantra, Tilak Ayurved Mahavidyalaya, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822522905 |
| Fax |
|
| Email |
nalawadenitin54@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin D Nalawade |
| Designation |
Associate Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Pune |
| Address |
Dept.Of Shalyatantra, Tilak Ayurved Mahavidyalaya, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822522905 |
| Fax |
|
| Email |
nalawadenitin54@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya, Rastapeth, Pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Rastapeth,pune -11 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSagar Dattatray Kathole |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital |
Opd No.7, Dept Of Shalyatantra
Pune
MAHARASHTRA |
7350984369
sagarkathole3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Tilak Ayurved Mahavidyalaya And Seth Tarachand Ramnath Charitable Ayurved Hospital,pune |
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 | Comparator Arm (Non Ayurveda) | | - | Betadine Ointment | Drug- Betadine Ointment
Route-Topical Application
Dose -as per wound Size
Frequency - OD
Period -15days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhuyukt sharpunkha choorna , Reference: Vrinda Madhav 44/ 34 , Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having Dusta Vrana (infected Wound) irrespective of sex, age, occupation including surgical wounds
2) OPD & IPD patients from Shalya department of affiliated hospital
3) Dusta Vrana having dimension from 1 cm to 6 cm
4) Patients ready to give written consent will be selected.
5) Patients suffering from dushtavrana and lakshana like- Raga (redness)
- Utsannamamsa (pale granulation tissue) - Vedanayukta(painful)
- Dustastrava(discharge)
- Dustagandhi(foul smelling) |
|
| ExclusionCriteria |
| Details |
Known case of -1) Osteomyelitis, Venous, Tubercular, Ischemic, Tropical, Neurogenic, malignant ulcers.2) Ulcers with gangrenous changes.
3) Patient is suffering from HIV.
4) Wound size more than 6 cm.
5)Diabetic wound. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Darshan Paariksha- Akruti,Vrana strava,Vrana Tala,Vranagandha
Saparshan pariksha-Sparshatva,local temperature
Prashn Pariksha- Daha,Vedna, kandu |
Baseline,1st, 3rd,5th,7th 10th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recurrance of Akruti,Vrana strava,Vrana Tala,Vranagandha
,Sparshatva,local temperature,Daha,Vedna, kandu |
After 15 days |
|
|
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)
|
30/12/2022 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Today wound is basic problem in surgical practice Surgeon deals with inflammation & problem in healing in any surgical disorder. Even though Vrana is a natural process of healing it should be protected from dosha dushti from various microorganism, which may affect the vrana and delay the normal healing process. Wound has different aspect for healing process If is left untreated can leads to complication. So we are looking for effective management. Dushta Vrana (Infected wound) is a common problem faced in surgical practice. The presence of Dushta Vrana worsens the condition of the patient with different complicationsand maybecome fatal. Wound healingisanatural process, but factors like slough, infection and foreign bodies, affect the normal process of healing. A healthy wound in anormal body heals earlier with a minimum scar as compared to a contaminated wound. Therefore in the present concept, all efforts are directed to keep the wound clean during the various stages of its healing process. Wound is a physical injury to any of the tissues in the body that results in a break in the continuity of soft parts of body structures[8]. A process of healing of wound is a normal biological response to the injury that occurs naturally, as long as the local care is adequate. The normal phases of wound healing-reaction, regeneration, and remodeling take place without any difficulty, if wound is debrided properly of non-viable tissue and repaired it in a physiological manner. Acharya Sushruta has given much emphasis on Vaikruthapaham. Hence good wound healing with minimal or no scar formation is the prime motto.Sushruta, Charaka, Vaghbhata, Madhavakar and Sharangdhara have clearly mentioned that the Lakshanas of Dushta Vrana as foul smelling, continuously flowing pus discharge along with blood filled cavities, which can be correlated to non-healing or contaminated wound. Infected wounds mostly require surgical debridement to stabilize the patient as well as to promote healing process, longer hospitalization, and surgery with use of anaesthesia drug, wound care and also other expenses. MADHUYUKTA SHARPUNKHA CHOORNA LEP has property of non surgical debridement, less painful and economical. Hence it can be most affordable and convenient non surgical treatment. |