| CTRI Number |
CTRI/2020/09/027801 [Registered on: 14/09/2020] Trial Registered Prospectively |
| Last Modified On: |
08/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic medication in management of wound |
|
Scientific Title of Study
|
A Pharmaceutical Standardization of Swarjikadya Ghrit with Different Forms in the Management of Wound |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jay Prakash Gupta |
| Designation |
Research Scholar |
| Affiliation |
DSRRAU JODHPUR |
| Address |
Room No 36 Department of Rasshastra and Bhaishajya Kalpana Dr S R Rajasthan Ayurved University Kadwad Jodhpur Nagaur Highway Road Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
09413510688 |
| Fax |
|
| Email |
j.p.gupta1806@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajaram Agarwal |
| Designation |
Associate Professor |
| Affiliation |
DSRRAU JODHPUR |
| Address |
Room No 34 Department of Rasshastra and Bhaishajya Kalpana Dr S R Rajasthan Ayurved University Kadwad Jodhpur Nagaur Highway Road Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166934499 |
| Fax |
|
| Email |
drrajaramagarwal69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Goyal |
| Designation |
Assistant Professor |
| Affiliation |
DSRRAU, JODHPUR |
| Address |
Room No 35 Department of Rasshastra and Bhaishajya Kalpana Dr S R Rajasthan Ayurved University Kadwad Jodhpur Nagaur Highway Road Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8890242078 |
| Fax |
|
| Email |
manishagoyal29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S R Rajasthan Ayurved University Jodhpur Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
University Collage of Ayurved Dsrrau Jodhpur |
| Address |
Kadwad Jodhpur Nagaur Highway Road Jodhpur |
| 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 Jay Prakash Gupta |
DSRRAU Hospital Jodhpur |
OPD No 10 Swasthya Rakshan Unit University Collage of Ayurved DSRRAU Jodhpur
Jodhpur
RAJASTHAN |
09413510688
j.p.gupta1806@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Swarjikadya Ghrit |
Daily Dressing with Swarjikadya Ghrit once a day after Washing with Panchvalkal Kwath for time period of 1 month and Follow up Will be 7 day |
| Comparator Agent |
Swarjikadya Ointment |
Daily Dressing with Swarjikadya Ointment once a day after Washing with Panchvalkal Kwath for time period of 1 month and Follow up will be 7 day |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diabetes mellitus type 2
Mild to Moderate Infected Wound
Abscess
Fissure in Ano
Stab Wound |
|
| ExclusionCriteria |
| Details |
Malignant Ulcer
Ulcer in Uncontrolled Diabetes
HIV or Any Immunodeficiency condition
HBsAg Positive
Tubercular Ulcer
Leprotic Wound
Any Malignancy
Renal Failure
Cardiac Failure
Venous Ulcer
Arterial Ulcer
Who are not willing to give Written Informed Consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Sign and Symptoms of Wound |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of Life |
1 month and 7 days From day of Enrollment |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/09/2020 |
| 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="10" |
|
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
|
The aim of the study is
to evaluate the comparative effect of different forms of Swarjikadya Ghrit in the management of the wound. In this trial, 30
patients will be randomly allocated into two groups. In Group A 15 patients will be
treated with daily dressing of Swarjikadya ghrit once after washing
with Panchvalkal kwath for a time period of 1 month and in
group B 15 patients will be treated with daily Dressing with
Swarjikadya ointment once after washing with Panchvalkal kwath for a time
period of 1 month and follow-up will be taken after 7 days in both groups.
Assessment will be done on the basis of change in the Sign and Symptoms of
Wound Qualitative and Quantitative variables will be assessed by the standard
parameters. The result will be assessed statically after completion of the trail. |