| CTRI Number |
CTRI/2019/06/019867 [Registered on: 26/06/2019] Trial Registered Prospectively |
| Last Modified On: |
24/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of infected wound |
|
Scientific Title of Study
|
Open randomised controlled clinical trial of patolyadi kwath 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 SAVITA LOKHANDE |
| Designation |
PG SCHOLAR |
| Affiliation |
YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
B-27/01, TAPASYA CHS, SECTOR-10, AIROLI, NAVI MUMBAI
SHALYA TANTRA DEPARTMENT 3RD FLOOR YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, INSTITUTIONAL AREA, SECTOR-4, KHARGHAR, NAVI MUMBAI-410210
Raigarh
MAHARASHTRA
400708
India |
| Phone |
9819696070 |
| Fax |
|
| Email |
savitalokhande55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DD CHAVAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF SHALYATANTRA 3RD FLOOR YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, INSTITUTIONAL AREA, SECTOR-4, KHARGHAR, NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9822221585 |
| Fax |
|
| Email |
dnyanesh7373@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DD CHAVAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF SHALYATANTRA 3RD FLOOR YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, INSTITUTIONAL AREA, SECTOR-4, KHARGHAR, NAVI MUMBAI
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9822221585 |
| Fax |
|
| Email |
dnyanesh7373@gmail.com |
|
|
Source of Monetary or Material Support
|
| B-27/01, TAPASYA CHS, SECTOR-10, AIROLI, NAVI MUMBAI-400708 |
| YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, INSTITUTIONAL AREA, SECTOR-4, KHARGHAR, NAVI MUMBAI-410210 |
|
|
Primary Sponsor
|
| Name |
DR SAVITA LOKHANDE |
| Address |
B-27/01, TAPASYA CHS, SECTOR-10, AIROLI, NAVI MUMBAI-400708 |
| 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 SAVITA LOKHANDE |
YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, INSTITUTIONAL AREA, SECTOR-4, KHARGHAR, NAVI MUMBAI-410210
Raigarh
MAHARASHTRA |
9819696070
savitalokhande55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Betadine solution |
Cleaning of wound will be done by betadine solution with gauze pieces and gauze dressing will be done daily for 21 days.
-Regular wound care will be taken.
- suitable medication like antibiotics, analgesics etc. will be prescribed as per need.
patient will be assessed on 0, 7th, 14th, 21st day. |
| Intervention |
Patolyadi kwath |
-Cleaning of the wound will be done by Patolyadi kwath with gauze pieces soaked in sterile bowl of patolyadi kwath , and gauze dressing will be done daily for 21 days.
-Regular wound care will be taken
- suitable medication like antibiotics, analgesics etc. will be prescribed as per need.
-Photographs of wound will be taken before and after treatment.
Patient will be assessed on 0 , 7th, 14th, 21st day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
-Age Above 18 yrs.
-Patients of any Gender.
-All patients with dushta vrana.
|
|
| ExclusionCriteria |
| Details |
-Age below 18 yrs .
-Lepromatous ulcer, malignant ulcer.
-Diabetic ulcer.
-Gangrenous ulcer.
-Varicose ulcer
-specific ulcers like Syphilitic ulcer, Tuberculous, Gonorrhoeal ulcer.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patolyadi kwath is more effective in management of dushtavrana as compared to betadine solution. |
Daily dressing will be done for 21 days . Assesment of wound will be done on day 1 , day 7 , day 14 and day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patolyadi kwath is less effective than betadine solution in management of dushtavrana. |
daily dressing will be done for 21 days
patient will be assessed on 0, 7th, 14th, 21st days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/07/2019 |
| 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="2"
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)?
|
|
Brief Summary
|
TITLE: Open Randomised Controlled Clinical trial of Patolyadi Kwath in the management of dushtavrana
TRIAL GROUP DRUG : Patolyadi Kwath CONTROL GROUP : BETADINE SOLUTION
CONTENTS: Patol, Nimba
CRITERIA FOR WOUND ASSESSMENT: A] SUBJECTIVE PARAMETERS: 1] PAIN (shool) 0=No pain 1=Mild (Patient can bear pain without analgesics) 2=Moderate (Patient respond to analgesics) 3=Severe (Patient does not respond to analgesics) 2] DISCHARGE (STRAVA) 0=No discharge. 1=scanty serous discharge & little wet dressing. 2=Often discharge and pus on dressing. 3=Profuse pus discharge which need frequent dressing. OBJECTIVE PARAMETERS: 1] FOUL SMELL (GANDHA): Present/Absent. 2]GRANULATION. 3=Complete granulation. 2=More granulation (>75%) &less pus (<25%). 1=Equal granulations and pus. 0=Less granulations (<25%) & more pus(>75%). 3] SIZE OF WOUND:. 0=Less than 1 Sq.cm. 1=1 to 2 Sq.cm. 2=2 to 3 Sq.cm. 3=3 to 4 Sq.cm.
Time points - daily dressing for 21 days . Assessment of wound will be done on day 1 , day 7 , day 14 and day 21 . SAMPLE SIZE - 80 patients 40 patients in trail group and 40 patients in control group |