| CTRI Number |
CTRI/2018/07/014972 [Registered on: 19/07/2018] Trial Registered Prospectively |
| Last Modified On: |
18/07/2018 |
| 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
|
Role Of Ayurveda Medicine in Wound Healing |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Yashadamrita Malahara in Shuddha 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 SUNNY |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B. M. K Ayurveda mahavidyalaya |
| Address |
Department of Shalya Tantra OPD No 08 and IPD of KLE Ayurveda Hospital and Research Center
Belgaum
KARNATAKA
590003
India |
| Phone |
8884888117 |
| Fax |
|
| Email |
drsunnysroy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNNY |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B. M. K Ayurveda mahavidyalaya |
| Address |
Department of Shalya Tantra OPD No 08 and IPD of KLE Ayurveda Hospital and Research Center
Belgaum
KARNATAKA
590003
India |
| Phone |
8884888117 |
| Fax |
|
| Email |
drsunnysroy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmikant S D |
| Designation |
Reader Department of Shalya Tantra |
| Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
| Address |
Department of Shalya Tantra OPD No 08 and IPD of KLE Ayurveda Hospital and Research Center
Belgaum
KARNATAKA
590003
India |
| Phone |
9480007651 |
| Fax |
|
| Email |
shalyalsd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M K Ayurveda mahavidyalaya and research center Shahpur
Belagavi Karnataka 590003 |
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
| Address |
Shri B M K Ayurveda mahavidyalaya and research center Shahpur
Belagavi Karnataka 590003 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sunny Roy |
Shri B M K Ayurveda mahavidyalaya Shahpur
Belagavi Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunny Roy |
KLE Ayurveda Hospital and Research Center |
Department of Shalya Tantra OPD No 08 and IPD of KLE Ayurveda Hospital and Research Center Shahpur Belagavi Karnataka 590003
Belgaum
KARNATAKA |
8884888117
drsunnysroy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KAHERs Shri B. M. K Ayurveda mahavidyalaya and KLE Ayurveda Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Either sex between 20-70 years of age.
Patients with the Lakshanas of Shuddha Vrana.
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Jatyadi Taila |
An Ayurveda medicated oil used for external wound application which will be applied for 15 days |
| Intervention |
Yashada Pushpa |
Yashada Pushpa + Sikta Taila
will be applied locally for 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the Lakshanas of Shuddha Vrana. |
|
| ExclusionCriteria |
| Details |
Patients suffering/ diagnosed from wound(s) associated with systemic diseases like diabetes mellitus, tuberculosis, malignant wounds, HbsAg, HIV I & II. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Yashadamrita Malahara would help in treating Shuddha Vrana more efficiently |
0th, 7th, 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/11/2018 |
| 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)?
|
|
Brief Summary
|
Acharya Sushruta
explains the vrana as the one which does the disruption of shareera dhatu,
which leaves the vrana vastu (scar) after ropana and remains till the end of
life. Acharya had also mentioned Shashti upakrama for the management of vrana,
which includes vrana ropana formulations.
A wound is a loss of
continuity of the skin or mucus membrane due to injury. The problem
of wound healing has been dealt with at various levels by mankind ever since
the advent of humanity. Proper healing of wounds is essential for the
restoration of anatomical continuity and disturbed functional status of the
skin. Worldwide prevalence of wounds is 1%, estimated that 1.5
million cases of traumatic wounds found every year, whereas an
Indian perspective of hospital-based study shows diabetes (23%), venous disease
(11%) and trauma (13%), were the important causes of extremity wounds.
As
there is a huge scope to work out and find a better result for wound healing.
Basic factor require in the wound healing is to provide antimicrobial
atmosphere, resisting the formation of slough and support for the growth of
granulation tissue. |