| CTRI Number |
CTRI/2017/03/007986 [Registered on: 02/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of jatyadi ghrita and karanjadi ghrita in the treatment of dushta vrana. |
|
Scientific Title of Study
|
A comparative clinical study of jatyadi ghrita and karanjadi ghrita in the management of Dushta Vrana. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HEMANT K KUBAVAT |
| Designation |
PG SCHOLAR |
| Affiliation |
government akhandanand ayurved college |
| Address |
pg scholar department of shalya tantra government akhandanand ayurved college bhadra ahmedabad 380001
12 kailashdham society jogeshwari park road opposite policeline 2 amraiwadi ahmedabad 380026
Ahmadabad
GUJARAT
380001
India |
| Phone |
9904420616 |
| Fax |
|
| Email |
hkkubavat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HARSHIT S SHAH |
| Designation |
READER |
| Affiliation |
government akhandanand ayurved college |
| Address |
department of shalyatantra government akhandanand ayurved college bhadra ahmedabad 380001
44/259 vijaynagar flats naranpura ahmedabad 13 gujarat
Ahmadabad
GUJARAT
380001
India |
| Phone |
9824068760 |
| Fax |
|
| Email |
sejharsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIPUL SANGANI |
| Designation |
LECTURER |
| Affiliation |
government akhandanand ayurved college |
| Address |
department of shalyatantra government akhandanand ayurved college bhadra ahmedabad 380001
230 manipur greens opp sankardham manipur ahmedabad gujarat
Ahmadabad
GUJARAT
380001
India |
| Phone |
9104549501 |
| Fax |
|
| Email |
drvipulsangani@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government akhandanand ayurved hospital laldarwaja bhadra ahmedabad |
|
|
Primary Sponsor
|
| Name |
Government akhandanand ayurved college and hospital |
| Address |
opd no 24 shalyatantra department Government akhandanand ayurved hospital laldarwaja bhadra ahmedabad 380001 |
| Type of Sponsor |
Government medical college |
|
|
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 Hemant K Kubavat |
Government akhandanand ayurved hospital and maniben ayurved hospital |
Government akhandanand ayurved hospital laldarwaja bhadra ahmedabad and Government maniben ayurved hospital asarva ahmedabad
Ahmadabad
GUJARAT |
9904420616
hkkubavat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
DUSHTA VRANA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Jatyadi ghrita dressing with panch valkala kwath prakshalan |
A dushta vrana prakshalana done with freshly preparedpanchvalkal kwath for vrana shodhan purpose and then dressing with jatyadi ghrita dressing done for dushta vrana ropana purpose ,patient advised for daily dressing upto 28 days and improvement or adverse effect observed before during and after treatment. |
| Intervention |
Karanjadi ghrita dressing with panch valkala kwath prakshalan |
A dushta vrana prakshalana done with freshly preparedpanchvalkal kwath for vrana shodhan purpose and then dressing with karanjadi ghrita dressing done for dushta vrana ropana purpose ,patient advised for daily dressing upto 28 days and improvement or adverse effect observed before during and after treatment. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.POST OPERATIVE WOUND WITH SYMPTOMS OF DUSHTA VRANA
2.VRANA SIZE WITHIN 5CMS BY 5 CMS
3.CLASSICAL SIGN AND SYMPTOMS OF DUSHTA VRANA DESCRIBED IN SUSHRUTA SUTRA STHANA 22 |
|
| ExclusionCriteria |
| Details |
1 Tubercular wound
2 Leprotic wound
3 Malignant wound
4 Diabetic wound
5 Wounds having excessive loss of tissues etc.
6 HIV reactive
7 HbsAg reactive
8 Wounds in patients of burgers disease
9 Varicose ulcer.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DECREASE THE SYMPTOMS OF DUSHTA VRANA LIKE SIZE,ITCHING,PAIN, DISCHARGE, BURNING, FOUL SMELL OR DECREASE THE SYMPTOMS OF DUSHTA VRANA |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease the symptoms of dushta vrana like pain itching burning pus discharge oedema |
28 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
06/08/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this a randomised parralal group trial in department of shalyatantra opd and ipd at government akhandanand ayurved hospital and maniben ayurved hospital ahmedabad gujarat. dealing with the treatment of disease dushta vrana . acharya sushruta has described that this disease shoud treat with various upkrama among them vrana shodhana and varana ropana and various drugs and therapies described to treat this disease.. in this clinico comparative trial in groupk: karanjadi ghrita and in group: j jatyadi ghrita is applied for dushta vrana shodhana and in both group vrana shodhana is done with prakshalana with panch valkala kwatha. |