| CTRI Number |
CTRI/2021/02/031344 [Registered on: 17/02/2021] Trial Registered Prospectively |
| Last Modified On: |
16/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An Ayurvedic medicine which is helpful in the healing of wounds |
|
Scientific Title of Study
|
Clinical study on efficacy of Prapaundrakadi Ghrita in Vrana Ropana with special reference to Wound Healing |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avinav pandey |
| Designation |
PG scholar/junior resident doctor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Shalya Tantra
Faculty of Ayurveda
IMS,Bhu
Varanasi
Department of Shalya Tantra
Faculty of Ayurveda
IMS,BHU,
VARANSI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839217785 |
| Fax |
|
| Email |
avinavayubhu26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShiv Ji Gupta |
| Designation |
professor and Head |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department Of Shalya Tantra
Faculty Of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415227419 |
| Fax |
|
| Email |
guptasjbhu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrShiv Ji Gupta |
| Designation |
professor and Head |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department Of Shalya Tantra
Faculty Of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415227419 |
| Fax |
|
| Email |
guptasjbhu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Ayurveda,IMS,Bhu,Varanasi |
|
|
Primary Sponsor
|
| Name |
DrAVINAV PANDEY |
| Address |
Department of Shalya Tantra
Faculty of Ayurveda
IMS,BHU
VARANASI |
| 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 |
| Avinav Pandey |
Sir Sundarlal Hospital, Institute of Medical Sciences |
Department of Shalya Tantra
Faculty of Ayurveda
IMS Bhu
Varanasi
UTTAR PRADESH |
9839217785
avinavayubhu26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M02||Infectious arthropathies. Ayurveda Condition: SUDDHAVRANAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placentrex gel |
Gel will be applied over the clean wound,20 to 50 gram,twice a day,over the wound,for 14 days |
| Intervention |
Prapaundrakadi Ghrita |
Ghrita will be applied over clean wound,in 20 to 50 gram,twice a day,for 14 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20 to 60 years
Clean wound
Patient of Diabetes Melitus having clean wound with cntrlled Diabetes Melitus |
|
| ExclusionCriteria |
| Details |
Malignant Ulcer
Ulcer in uncntrolled diabetic patient
HIV,HBSAG,ANTI HCV psitive patient
Tubercular ulcer
Arterial and Venous ulcer
Patient suffering from chronic debilitating condition
Who are not willing to give written consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to Bates-Jensen Wound Assessment Tool |
on 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| According to Bates-Jensen Wound Assesament Tool |
Upto 14 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
18/02/2021 |
| 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="2"
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
|
CLINICAL STUDY ON EFFICACY OF PRAPAUNDRAKADI GHRITA IN VRANA ROPANA WITH SPECIAL REFERENCE TO WOUND HEALING. I will admit a patient on the basis of my inclusion criteria after that i will apply ghrita over the clean wound and I will asses wound healing on the patient on 7th and 14th day. |