| CTRI Number |
CTRI/2024/12/078001 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Ayurveda
Other (Specify) [Interventional] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management Of Vranashopha (Cellulitis) In Reducing Duration Of Inflammation By Using Of Jalaukavacharan versus Glycerine Magnesium Sulphate Dressing |
|
Scientific Title of Study
|
Effect Of Jalaukavacharan In Reducing Duration Of Inflammation In Vranashopha (Cellulitis) Compare With Glycerine Magnesium Sulphate Dressing: A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prakash Vishwambhar Failwad |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya,Nagpur |
| Address |
Opd No.7,Shalyatantra Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar Nagpur Dhanwantari Marga, Nagpur Maharashtra 440024 Nagpur Nagpur MAHARASHTRA 440024
India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9665284792 |
| Fax |
|
| Email |
failwadprakash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Pradeep Dalal |
| Designation |
HOD And Professor Of Shalya Tantra |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
Opd No.7,Shalyatantra Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar Nagpur Dhanwantari Marga, Nagpur Maharashtra 440024 Nagpur Nagpur MAHARASHTRA 440024
India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9975830051 |
| Fax |
|
| Email |
drjyoti.dalal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash Vishwambhar Failwad |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
Opd No.7,Shalyatantra Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar Nagpur Dhanwantari Marga, Nagpur Maharashtra 440024 Nagpur Nagpur MAHARASHTRA 440024
India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9665284792 |
| Fax |
|
| Email |
failwadprakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pakwasa samanway rugnalaya, Shri Ayurved mahavidyalaya, Hanuman Nagar, Dhanwantari Marga, Nagpur Maharashtra 440024. |
|
|
Primary Sponsor
|
| Name |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
Opd No.7,Shalyatantra Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar Nagpur Dhanwantari Marga, Nagpur Maharashtra 440024 Nagpur Nagpur MAHARASHTRA 440024
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prakash Viahwambhar Failwad |
Shri Ayurved Mahavidyalaya, |
Opd No.7,Shalyatantra Department, Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Hanuman Nagar Nagpur Dhanwantari Marga, Nagpur Maharashtra 440024 Nagpur Nagpur MAHARASHTRA 440024
India
Nagpur
MAHARASHTRA |
9665284792
failwadprakash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of shri Ayurved Mahavidyalaya |
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: VRANASOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Glycerine magnesium sulphate | It reffers to gauze pad soaked in warm 20mg magnesium sulphate granules saturated with 100ml glycerine, topically applied and secured with roller bandage. | | 2 | Intervention Arm | Procedure | - | JalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Sushrut , Chikitsa sthan 1/27,28,29,30, Procedure details: 1.Preparation of leech
2.Preparation of Patient
3.Active leech kept over swelling site (wherever cellulitis is occured)
4.The process of blood sucking will be confirrrmed by the peristaltic movement on the body of leech.
5.When the leech completes blood sucking it will detacheitself from site (45minutes)
6.Jaluaka will be applied on alternate day up to the day of nine.(5 times))
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed case of amavastha and pachyamana avastha of Vranashopha.
2.Patient of age group between 18-60 years.
3.Patient fit for Raktamokshana.
4.Cellulitis due to varicosity. |
|
| ExclusionCriteria |
| Details |
1.Pakwavastha of Vranashopha.
2.Uncontrolled systemic diseasis such as HTN,DM etc
3.Immuno-compromised patients
4.Severe anemia.
5.Septicemia.
6.Morbid obesity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study may provide use of jalaukavacharan in reducing duration of inflammation in Vranashopha |
At the end of 9 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparative effect of reducing duration of inflammation in vranashopha between jalaukavacharan and glycerin magnesium sulphate dressing will be assessed. |
At the end of 9 days |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 3 |
|
Date of First Enrollment (India)
|
25/12/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be carried out at opd of shalyatantra of Pakwasa Samnvay Rugnalaya Nagpur .This is an open label randomized controlled trial aims at studying the effect of jalaukavacharan in reducing duration of inflammation in vranashopha (cellulitis) comparing with glycerine magnesium sulphate dressing . Total 56 patients will be included and will be randomly divided into two groups i.e. Group A and Group B each containing 28 patients.Group A will be trial group where patients will receive Jalaukavacharan and Group B will be control group will receive application of glycerine magnesium sulphate dressing . Then patients will be observed on 1st, 3rd,5th,7th and 9st day. All the findings will be recorded in case record form, At the end of trial,collected data will be analyzed and result will be drawn accordingly. |