| CTRI Number |
CTRI/2021/02/031508 [Registered on: 23/02/2021] Trial Registered Prospectively |
| Last Modified On: |
13/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The Efficacy Of Karvellak Siddha Taila And Eusol Dressing In The Management Of DushtaVrana |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study To Evaluate The Efficacy Of Karvellak Siddha Taila And Eusol Dressing In The Management Of DushtaVrana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishnu Hanumantrao Rankhamb |
| Designation |
MS PG student surgery department |
| Affiliation |
SSAM Hadapsar Pune. |
| Address |
OPD No 3, Shalyatantra Department, Sane Guruji Hospital malwadi Hadapsar Pune.
Malwadi Hadapsar Pune 415 028
Pune
MAHARASHTRA
415028
India |
| Phone |
8624805390 |
| Fax |
|
| Email |
vishnurankhamb99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mali Sandip |
| Designation |
MS Shalya Ph D |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar |
| Address |
OPD No 3, Shalyatantra Department, Sane Guruji Hospital Hadapsar Pune
Malwadi Hadapsar Pune 415 028
Pune
MAHARASHTRA
415028
India |
| Phone |
9284993423 |
| Fax |
|
| Email |
sandymonias@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnu Hanumantrao Rankhamb |
| Designation |
MS PG student surgery department |
| Affiliation |
SSAM Hadapsar Pune. |
| Address |
OPD No 3, Shalyatantra Department, Sane Guruji Hospital malwadi Hadapsar Pune.
Malwadi Hadapsar Pune 415 028
Pune
MAHARASHTRA
415028
India |
| Phone |
8624805390 |
| Fax |
|
| Email |
vishnurankhamb99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane Guruji Hospital OPD no 3 Shalyatantra Department Hadapsar Pune. |
|
|
Primary Sponsor
|
| Name |
Dr Vishnu Hanumantrao Rankhamb |
| Address |
OPD no 3 Shalyatantra Department Malwadi Hadapsar Pune 415 028 |
| Type of Sponsor |
Other [Self] |
|
|
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 Vishnu Hanumantrao Rankhamb |
Sane Guruji Hospital |
OPD no 3 Shalyatantra Department Sane Guruji Hospital Malwadi Hadapsar Pune 415 028
Pune
MAHARASHTRA |
8624805390
vishnurankhamb99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SSAM pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T07||Unspecified multiple injuries. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
application of EUSOL solution on infected wound. |
to evaluate the efficusy of karvellak siddha taila in the management of dushtavrana.Sample size 30 patients are randomaly taken for this study.total duration of study is 15 days.Quantity ofEUSOL solution will be applied as per wound size . |
| Intervention |
karvellak siddha taila application on infected wound |
to evaluate the efficusy of karvellak siddha taila in the management of dushtavrana.Sample size 30 patients are randomaly taken for this study.total duration of study is 15 days.Quantity of taila will be applied as per wound size . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient having infected wound ,wpund size upto 8cm,diabetic patient with infected wound |
|
| ExclusionCriteria |
| Details |
burn,Arterial Ulcer,Vericose Ulcer,HIV & Immuno-Compromised patient,Gangrenous wound |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| karvellak siddha taila is effective on infected wound( Dushtavrana) |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| there is no difference in efficasy of karvellak siddha taila or there is less/equal/more difference in Efficasy in karveelak siddha taila in the managemnt of dushtavrana |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/02/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title- | Randomised Controlled Clinical Study To Evaluate The Efficacy Of Karvellak Siddha Taila And Eusol Dressing In The Management Of DushtaVrana | |
Nowadays in urban areas mostly we see wound is managed by application of various solutions such as Betadine, eusol, H2O2 etc. People in tribal areas for whom hospitals are far away can apply Karvellak siddha taila on wound instead of daily visiting the hospital for dressing. In rural areas especialy where there is unavailability of dressing solution, treatment of such infected wound becomes difficult ultimately remaining untreated, this causes severe infection and sepsis. Ayurveda has mentioned excellent treatment regimen for dushta vrana, which can be used as treatment of dushta vrana.
This study plan to access efficacy of Karvellak Siddha Taila in the management of DushtaVrana.
Sample Size- patient having infected wound upto 8cm size.
Exclusion Criteria- burn ,arterial Ulcer ,venous Ulcer, HIV ,bed sore Duration 15 days Administration- local application Dose- as per wound size.
|