| CTRI Number |
CTRI/2022/10/046751 [Registered on: 25/10/2022] Trial Registered Prospectively |
| Last Modified On: |
21/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [LOCAL APPLICATION ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Study of Shodhan and Ropan efficacy of local application of Darvyadi Ghrita in the managment of Dushta Awastha of Vrana w.r.s Infected wound. |
|
Scientific Title of Study
|
"Study of Shodhan and Ropan efficacy of local application of Darvyadi Ghrita in the managment of Dushta Awastha of Vrana with special reference to Infected wound. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JYOTI ACHHELAL CHAUHAN |
| Designation |
P.G. scholar |
| Affiliation |
Government Ayurved college and hospital |
| Address |
Deparment of Shalyatantra Government Ayurved college and hospital,vazirabad Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
8928945522 |
| Fax |
|
| Email |
chauhanj9819@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VP UKHALKAR |
| Designation |
Associate professor |
| Affiliation |
Government Ayurved college and hospital |
| Address |
Department of Shalyatantra
Government Ayurved College
and Hospital Vazirabad Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
7755921987 |
| Fax |
|
| Email |
ukhalkarvp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VP UKHALKAR |
| Designation |
Associate professor |
| Affiliation |
Government Ayurved college and hospital |
| Address |
Department of Shalyatantra
Government Ayurved College
and Hospital Vazirabad Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
7755921987 |
| Fax |
|
| Email |
ukhalkarvp@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College Vazirabad Nanded |
|
|
Primary Sponsor
|
| Name |
Jyoti Achhelal Chauhan |
| Address |
Dept of shalyatantra Government ayurved college and hospital vazirabad Nanded |
| Type of Sponsor |
Other [Self sponsered ] |
|
|
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 |
| JYOTI ACHHELAL CHAUHAN |
Government Ayurved Hospital Nanded |
Department of
Shalyatantra Hospital
building OPD No. 6 & 7
IPD Ward No. 51 & 63
Nanded
Maharashtra.
Nanded
MAHARASHTRA |
8928945522
chauhanj9819@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 |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvyadi ghruta, Reference: Gad nigrah kayachikitsa khanda 60, Route: Topical, Dosage Form: Ghrita, Dose: 1(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Betadine Ointment | Topical Application of betadine Ointment in management of Infected Wound . |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient of Dushta Awastha of Vrana
2.Wound size(30mmTO 150mm).
3.Wounds upto muscle. |
|
| ExclusionCriteria |
| Details |
1.Patient with malignancy
2.Bleeding disorder.
3.Asthmatic patient.
4.Steroid dependent/immunocompromised.
5.HIV,Hbsag.
6.Anemic patient having HB<8gm%.
7.Any acute systemic, organic disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased Slough |
15 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relieving pain,
Decreased foul smail,
Decreased discharge,
Decreased Slough at the site of wound. |
15days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
27/10/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS RANDOMIZED SINGLE BLIND CONTROLLED CLINICAL STUDY OF LOCAL APPLICATION OF DARVYADI GHRITA DAILY AND FOLLOW UP ON 0TH, 3RD ,7TH, 11TH, 15TH DAY. THIS STUDY IS CONDUCTED AS PG COURSE AT SINGLE CENTRE . THE PRIMARY OUTCOME IS TO STUDY THE EFFICACY LOCAL APPLICATION OF DARVYADI GHRITA IN THE MANAGEMENT OF DUSHTA AVASTHA OF VRANA WITH SPECIAL REFERENCE TO INFECTED WOUND. |