| CTRI Number |
CTRI/2026/03/105968 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study to Evaluate the Effect of Ayurvedic Leech Therapy and Modern Serratiopeptidase in Reducing Inflammation in patients with Cellulitis ageing from 18-60 years |
|
Scientific Title of Study
|
A randomized controlled trial of Jalaukavacharana in comparison with Serratiopeptidase in reducing inflammatory markers in Vranashopha w.s.r. Cellulitis |
| 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 Poonam Shamrao Malave |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
OPD NO 7, Shalyatantra
Department, Pakwasa
Samanvay Rugnalaya, Shri
Ayurved Mahavidyalaya,
Dhanwantari Marg, Hanuman
Nagar, Nagpur Maharashtra
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8625096424 |
| Fax |
|
| Email |
poonammalve90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Khobragade |
| Designation |
Associate Professor, Department of Shalyatantra |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
OPD NO 7, Shalyatantra
Department, Pakwasa
Samanvay Rugnalaya, Shri
Ayurved Mahavidyalaya,
Dhanwantari Marg, Hanuman
Nagar, Nagpur Maharashtra
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9987014379 |
| Fax |
|
| Email |
drsandesh1128@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Shamrao Malave |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
OPD NO 7, Shalyatantra
Department, Pakwasa
Samanvay Rugnalaya, Shri
Ayurved Mahavidyalaya,
Dhanwantari Marg, Hanuman
Nagar, Nagpur Maharashtra
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8625096424 |
| Fax |
|
| Email |
poonammalve90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurved Mahavidyalaya Pakwasa Samanvay Rugnalaya Dhanwantari Marg Hanuman
Nagar Nagpur Maharashtra 440024 |
|
|
Primary Sponsor
|
| Name |
Shri Ayurved Mahavidyalaya, Nagpur |
| Address |
Shri Ayurved Mahavidyalaya Pakwasa Samanvay Rugnalaya Dhanwantari Marg Hanuman
Nagar Nagpur Maharashtra 440024 |
| 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 Poonam Shamrao Malave |
Shri Ayurved Mahavidyalaya, Nagpur |
OPD NO 7, Shalyatantra Department, Pakwasa Samanvay Rugnalaya, Shri
Ayurved Mahavidyalaya, Dhanwantari Marg, Hanuman Nagar, Nagpur
Maharashtra 440024
Nagpur
MAHARASHTRA |
8625096424
poonammalve90@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:L039||Cellulitis and acute lymphangitis,unspecified. Ayurveda Condition: VRANASOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Serratiopeptidase | Medicine Name: Serratiopeptidase
Route: Oral
Dosage Form: Tablet, Dose: 15(mg),
Frequency: BD, Duration: 14 Days | | 2 | Intervention Arm | Procedure | - | Jalaukavacharana Pradhan Karma | (Procedure Reference: Sushruta. Sushruta Samhita. Chikitsa Sthana, Chapter 13, Verse 4. In: Vaidya Yadavji Trikamji Acharya, editor. Varanasi: Chaukhambha Surbharati Prakashan; 2017., Procedure details: Alternate days upto 8 sittings)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Amavastha and Pachyamana avastha of Vranashopha.
Patient of age group between 18 - 60 years.
Patient fit for Raktamokshana |
|
| ExclusionCriteria |
| Details |
Pakwavastha of Vranashopha
Uncontrolled systemic diseases such as HTN, DM etc.
Immuno-compromised patients.
Severe anemia.
Septicemia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It may show reduction in inflammatory marker( CRP, ESR, TLC ) in the patient of cellulitis treated with jalaukavacharan. |
At the end of 14 days (1, 7, 14 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It may show therapeutic effect of Jalaukavacharana in reducing the signs and symptoms of inflammation in the both group in Calor (heat) Dolor (pain) Tumor (swelling)
Rubor (redness) in patients presenting with Vranashopha (cellulitis).
It shows the efficacy of both the treatment in patient of cellulitis. |
At the end of 14 days (1, 7, 14 days) |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
30/03/2026 |
| 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 Department of Pakwasa Samnvay Rugnalaya, Shri Ayurved Mahavidyalaya, Nagpur. This is an open label randomized controlled trial aims at studying the comparison between jalaukavacharan and serratiopeptidase in reducing inflammatory marker in patients of vranashopha (cellulitis).Total 54 patients will be included and will be randomly divided into two groups i.e. Group A and Group B each containing 27 patients. Group A will be trial group where patients will receive jalaukavacharan and Group B will be the control group where patients will receive serratiopeptidase. Then patients will be observed on 1, 7th, and 14th 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. |