| CTRI Number |
CTRI/2020/11/029331 [Registered on: 24/11/2020] Trial Registered Prospectively |
| Last Modified On: |
18/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Triphala Ghrita tulle
(Vikeshika) and betadine tulle (Vikeshika) dressing in the management of Dushta
Vrana (Infected wound). |
|
Scientific Title of Study
|
Randomised comparative clinical study to evaluate the efficacy of Triphala Ghrita tulle
(Vikeshika) and betadine tulle (Vikeshika) dressing in the management of Dushta
Vrana (Infected wound). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrita Bhausaheb Dandekar |
| Designation |
PG student Surgery Department |
| Affiliation |
Sumatibhai Shah ayurved mahavidyalya hadapasar pune |
| Address |
OPD no 3 ,Shalyatantra Department, Sane Guruji Hospital Malwadi Hadapsar Pune
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8668582524 |
| Fax |
|
| Email |
amrutadandekar2524@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Kale |
| Designation |
Professor |
| Affiliation |
Sumatibhai shah ayurved mahavidyalya malwadi hadapasar pune |
| Address |
OPD no 3 Sane Guruji Hospital Malwadi Hadapsar Pune
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822244893 |
| Fax |
|
| Email |
drrakale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrita Bhausaheb Dandekar |
| Designation |
PG student Surgery Department |
| Affiliation |
Sumatibhai Shah ayurved mahavidyalya hadapasar pune |
| Address |
OPD no 3 Shalyatantra Department, Sane Guruji Hospital Malwadi Hadapsar Pune
Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8668582524 |
| Fax |
|
| Email |
amrutadandekar2524@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 3, Shalyatantra Department, Sane Guruji Hospital Malwadi Hadapsar Pune28 |
|
|
Primary Sponsor
|
| Name |
Amrita Bhausaheb Dandekar |
| Address |
OPD no 3 Sane Guruji Hospital Malwadi Hadapsar Pune |
| 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 |
| Amrita Bhausaheb Dandekar |
Sane Guruji hospital Malwadi hadapasar pune |
OPD no 3 Shalyatantra Department,Sane Guruji Hospital Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8668582524
amrutadandekar2524@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe , SSAM hadapasar pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Povidine Iodine |
Povidine Iodine |
| Intervention |
Randomised comparative clinical study to evaluate the efficacy of Triphala Ghrita tulle
(Vikeshika) and betadine tulle (Vikeshika) dressing in the management of Dushta
Vrana (Infected wound). |
Infected wound is one of the major contributors to morbidity and mortality. World
wise annually 2 million cases concern annually worldwide.(6) Each year it is to
estimate that infected wound develops in 2%-5% of the 16 million patients
undergoing surgical procedure.(7)
There is infection of wound is difficult to define and
no clear rules can be given to distinguish from contamination and colonisation.(8) This
study plans to assess efficacy of Triphala Ghrita tulle (Vikeshika) in the management
of Dushta Vrana.
Sample size - 60
route of administration - local application
Dose- as per wound site
Duration- 15 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having infected wound.
Wound size 3 cm x 3 cm to 15 cm x 15 cm.
Infected wound due to trauma and accident.
Post-operative all infected wound
Age group 18 yrs to 60 yrs.
Gangrenous wound
Diabetic infected wound |
|
| ExclusionCriteria |
| Details |
Neoplastic ulcer
Other associated disorders e.g. gout, renal failure
Liver failure; Bed sores
Varicose ulcer
HIV & and immunocompromised patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Triphala Ghrita tulle (Vikeshika) is effective in the management of Dushtavrana.
(Infected wound) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Triphala Ghrita tulle (Vikeshika) is not effective in the management of
Dushtavrana(Infected wound)
There is significant difference in the efficacy of Triphala Ghrita tulle
(Vikeshika) and Betadine tulle (Vikeshika) in the management of Dushtavrana |
1 yr |
|
|
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)
|
02/12/2020 |
| 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 of study - Randomised comparative clinical study to evaluate the efficacy of Triphala Ghrita tulle (Vikeshika) and betadine tulle (Vikeshika) dressing in the management of Dushta Vrana (Infected wound). Sample size - 60 Inclusion criteria - Patient having infected wound. Wound size 3 cm x 3 cm to 15 cm x 15 cm. Infected wound due to trauma and accident. Post-operative all infected wound Age group 18 yrs to 60 yrs. Gangrenous wound Diabetic infected wound Exclusion Criteria Neoplastic ulcer Other associated disorders e.g. gout, renal failure Liver failure; Bed sores Varicose ulcer HIV & and immunocompromised patients Duration -15 days Administration - local application Dose - as per wound size |