| CTRI Number |
CTRI/2022/05/042741 [Registered on: 23/05/2022] Trial Registered Prospectively |
| Last Modified On: |
16/05/2022 |
| 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
|
Application Of Durvadi Ointment In Wound Healing With Special Reference To Sadyovrana. |
|
Scientific Title of Study
|
Randomized Controlled Trial Of Durvadi Ointment In Wound Healing With Special Reference To Sadyovrana. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Navso Desai |
| Designation |
3rd yr PG Scholar |
| Affiliation |
government ayurved collage and hospital,nagpur |
| Address |
Shalyatantra department, government ayurved collage, nagpur
Shalyatantra department,government ayurved collage and hospital nagpur,440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9420915613 |
| Fax |
|
| Email |
ridzdesai4293@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nita Kedar |
| Designation |
Associate professor |
| Affiliation |
government ayurved collage and hospital,nagpur |
| Address |
Shalyatantra department, government ayurved collage Nagpur
Shalyatantra department government ayurved collage and hospital nagpur,440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9960640613 |
| Fax |
|
| Email |
drnita6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNita Kedar |
| Designation |
Associate professor |
| Affiliation |
government ayurved collage and hospital,nagpur |
| Address |
Shalyatantra department, government ayurved collage Nagpur
Shalyatantra department government ayurved collage and hospital nagpur,440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9960640613 |
| Fax |
|
| Email |
drnita6@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of Shalyatantra department of government ayurved collage and hospital nagpur |
|
|
Primary Sponsor
|
| Name |
Priyanka Navso Desai |
| Address |
shalyatantra department,govt. ayurved collage and hospital,nagpur.440024 |
| 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 |
| Priyanka Navso Desai |
Government ayurved collage and hospital Nagpur |
Shalyatantra department,
Room no.3
Nagpur
MAHARASHTRA |
9420915613
ridzdesai4293@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,government ayurved collage and hospital nagpur |
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: VRANAH, (2) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Durvadi ointment, Reference: Charak samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Durvadi ointment, Reference: Charaksamhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Local application of durvadi ointment | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Povidone iodine, Reference: Modern medicine, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -local application of povidone iodine ointment |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient having traumatic incised wound.
Wound having length upto 5cm and depth upto 2cm .
Wound with duration upto 7 days with or without treatment.
Wound without any major complications.
Cooperative Patients. |
|
| ExclusionCriteria |
| Details |
Patients having major systemic diseases
Anaemia (Hb% < 8gm)
Wound after 7days.
Non cooperative Patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Durvadi ointment with Povidone iodine ointment on grannulation in healing of Sadyovrana. |
One and half year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effect of Durvadi ointment on granulation and wound contracture. |
One and half year |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 |
|
Date of First Enrollment (India)
|
01/06/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sushruta briefly contributed about knowlwdge of wound and its management. In ayurveda wound care has been given most importance.Mainly sushruta has given shashti upkramas for vrana which include 60 types of karma by which wound care is done. In this 60 upkramas shodhan and ropana are the two main aims in wound healing. The purpose of studying the mechanism of wound healing is to increase our basic understanding of the molecular and cellular events of cellular repaire and wound healing process and to use this information as basic for developing new therapies and consequences.the therapy should enhance cellular repair,promote rapid wound closure ,minimise hypertrophic scarring and controll scar contracture. In this study effoorts have been made to see the efficacy of ayurvedic preparation described in ch.chi.25/91 in the form of ointment as durvadi ointment. For this study 70 subjects will be equally randomized to experimental and controll group.athe trial drug Durvadi ointment and controll drug Povidone iodine ointment will be applied on fresh bleeding incised wound using the same SOP. follow up on 0,3,5,7,10 day of treatment will be taken in both trial and controll group.according to data acquired through this study discussion will be done. all results will be put forth in detail as per results obtained by application of data will be analysed and expressed statistically. |