| CTRI Number |
CTRI/2020/12/029577 [Registered on: 04/12/2020] Trial Registered Prospectively |
| Last Modified On: |
08/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
wound(Vrana) |
|
Scientific Title of Study
|
To Evaluate The Efficacy Of Panchavalkala Kashaya In The Management Of Mild To Moderate 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 |
PRERNA VERMA |
| Designation |
JUNIOR RESIDENT III |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE BHU VARANASI |
| Address |
Department Of Shalya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Nagarjuna Girls Hostel, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8808588573 |
| Fax |
|
| Email |
vermaprerna2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Awadhesh kumar Pandey |
| Designation |
Assistant Professor |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE BHU VARANASI |
| Address |
Department Of Shalya Tantra, Room no.5,Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Department Of Shalya Tantra, Room No.5 Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7376887965 |
| Fax |
|
| Email |
awadheshoct20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Awadhesh kumar Pandey |
| Designation |
Assistant Professor |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE BHU VARANASI |
| Address |
Department Of Shalya Tantra,
Room No.5,Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Department Of Shalya Tantra, Room No.5,Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7376887965 |
| Fax |
|
| Email |
awadheshoct20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences,IMS,B.H.U |
|
|
Primary Sponsor
|
| Name |
Department Of Shalya Tantra |
| Address |
Department Of Shalya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr S P Mishra |
Department Of Shalya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAwadhesh Kumar Pandey |
Institute Of Medical Sciences,B.H.U, |
Department of Shalya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH |
07376887965
awadheshoct20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PANCHAVALKALA KASHAYA |
Dose-30-50 ml
applied once in a day
till 1 month |
| Intervention |
PANCHAVALKALA KASHAYA |
NA |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Controlled diabetes mellitus
2. Mild to moderate infected wound |
|
| ExclusionCriteria |
| Details |
1. Malignant Ulcer
2. Ulcers in Uncontrolled Diabetics
3. HIV or any immunodeficiency condition
4. Hbs Ag Positive
5. Tubercular Ulcer
6. Leprotic Ulcer
7. Any Malignancy
8. Renal Failure
9. Cardiac Failure
10. Venous Ulcer
11. Arterial Ulcer
12. Who are not willing to give written informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SIZE
DEPTH
EDGES
UNDERMINING
NECROTIC TISSUE TYPE
NECROTIC TISSUE AMOUNT
EXUDATE TYPE
EXUDATE AMOUNT
SKIN COLOR SURROUNDING WOUND
PERIPHERAL TISSUE EDEMA
PERIPHERAL TISSUE INDURATION
GRANULATION TISSUE
EPITHELIALIZATION
|
0-28 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SIZE
DEPTH
EDGES
UNDERMINING
NECROTIC TISSUE TYPE
NECROTIC TISSUE AMOUNT
EXUDATE TYPE
EXUDATE AMOUNT
SKIN COLOR SURROUNDING WOUND
PERIPHERAL TISSUE EDEMA
PERIPHERAL TISSUE INDURATION
GRANULATION TISSUE
EPITHELIALIZATION
|
0-28 DAYS |
SIZE
DEPTH
EDGES
UNDERMINING
NECROTIC TISSUE TYPE
NECROTIC TISSUE AMOUNT
EXUDATE TYPE
EXUDATE AMOUNT
SKIN COLOR SURROUNDING WOUND
PERIPHERAL TISSUE EDEMA
PERIPHERAL TISSUE INDURATION
GRANULATION TISSUE
EPITHELIALIZATION
|
0-28 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)
|
14/12/2020 |
| 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="0"
Months="10"
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
Modification(s)
|
objective:- To Assess the Efficacy of Panchavalakala Kashaya in management of mild to moderate infected wound.
Plan of Study- Total 40 Patients of vrana will be registered from OPD/IPD of Department of Shalya Tantra, S.S.H., B.H.U., Varanasi. Patients will be registered urespective of their age, sex and religion which are fulfilling the inclusion and exclusion criteria. Patients will be enrolled after thorough interrogation, laboratory investigations and clinical assessment on a set proforma. Effect of Panchavalkala kwatha is compared with normal saline. Clinical study will be conducted on patients with infected wound by randomly dividing them into 2 groups :- A) 0.9% Normal Saline (Control Group) B) Panchavalkala Kwatha (Trial Group) Lab.Investigations: Hb% Total and differential WBC count with ESR Serum creatinine/ Blood urea Blood sugar RFT/LFT Wound microbial load count (Asses for bactarial load range between mild to moderate) Wound tisue biopsy-HPE ( 0 day and 28th day) HIV · Hbs Ag Assessment criteria-: Subjective -: Physical Examination of the wound: Objective -: Microbiological study- (Assess for bacterial load range between mild to moderate) Histopathological examination (Registration day - 0 day After - 28th day) Biochemical Parameter-: To Assess Quantitative Estimation of VEGF, before treatment (0 day), during treatment (14 and 28 day).
|