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CTRI Number  CTRI/2024/10/075675 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study To Evaluate The Effect Of Leech Application In Keloid.  
Scientific Title of Study   A Single Arm Clinical Study To Evaluate The Role Of Jalaukavacharan For Kandu And Daha In Vranagranthi (Keloid). 
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 Pragati Krushnarao Ghuse 
Designation  PG Scholar MS Shalyatantra 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri MAHARASHTRA 415722 India

Ratnagiri
MAHARASHTRA
415722
India 
Phone  9309976394  
Fax    
Email  pragati1998ghuse@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Devidas Pawar 
Designation  Associate Professor 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri MAHARASHTRA 415722 India

Ratnagiri
MAHARASHTRA
415722
India 
Phone  9822285836  
Fax    
Email  dr.ashok2575@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Pragati Krushnarao Ghuse 
Designation  PG Scholar MS Shalyatantra 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri MAHARASHTRA 415722 India

Ratnagiri
MAHARASHTRA
415722
India 
Phone  9309976394  
Fax    
Email  pragati1998ghuse@gmail.com  
 
Source of Monetary or Material Support  
MES Ayurved Mahavidyalaya and attached Parshuram Hospital & Research Center Ghanekhunt Lote Khed Ratnagiri Maharashtra India-415722 
 
Primary Sponsor  
Name  Dr. Pragati Krushnarao Ghuse 
Address  MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India-415722. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pragati Ghuse  Parshuram Hospital  Shalyatantra OPD no-1 Parshuram Hospital and Research Center Ghanekhunt Lote, Khed Ratnagiri Maharashtra
Ratnagiri
MAHARASHTRA 		 9309976394

pragati1998ghuse@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MES Ayurved mahavidyalaya ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L918||Other hypertrophic disorders of the skin. Ayurveda Condition: VRANAJAGRANTHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: Sushrut Samhita, Procedure details: Site will be cleaned with NS & rubbed with gauze piece. leech will be applied on 0th,7th,14th,21st day. After detachment of leech dressing will be done with turmeric powder.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient of vranagranthi with daha and kandu
2.Age group 18-60years.
3.Patients with written consent.
4.vranagranthi from all over the body except face
5.Patient indicated with jalaukavacharan
6.Patients with familial pedigree for developing vranagranthi

 
 
ExclusionCriteria 
Details  1.vrana granthi over vital areas.
2.Patient with uncontrolled Diabetes mellitus and hypertention.
3.Patient with bleeding disorder
4.Pregnancy
5.Patient with long term use of systemic corticosteroid , systemic chemotherapy or immunosuppresive drugs.
6.Patient with allergy to leeches.
7.Patient on anticoagulant medication. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of leech application in keloid  21 days study with follow up on 7th,14th,21st and 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. To establish jalaukavacharan as an effective treatment modality in vranagranthi .
2. Literature review of vranagranthi from ayurvedic text.
3. Literature review of keloid from modern texts.
4. Literature review of jalaukavacharan from ayurvedic text.
5. Literature review of leech therapy from modern texts. 		 21 days study with follow up on 7th,14th,21st and 28th day 
 
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   N/A 
Date of First Enrollment (India)   01/11/2024 
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 Applicable 
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  
Title- A SINGLE ARM CLINICAL STUDY TO EVALUATE THE ROLE OF JALAUKAVACHARAN FOR KANDU AND DAHA IN VRANAGRANTHI (KELOID).



Null Hypothesis : H0    Jalaukavacharan is not effective in vranagranthi(keloid).



Alternative Hypothesis : H1     Jalaukavacharan is effective in vranagranthi(keloid).


Study design -Single arm open label clinical trial



Inclusion Criteria: 
1)Patient of vranagranthi with daha and kandu
2)Age group 18-60years. 
3)Patients with written consent.
4)vranagranthi from all over the body except face
5) Patient indicated with jalaukavacharan
6)Patients with familial pedigree for developing vranagranthi


[2] Exclusion Criteria: 
1) vrana granthi over vital areas. 
2)Patient with uncontrolled Diabetes mellitus and hypertention.
3)Patient with bleeding disorder
4)Pregnancy
5)Patient with long term use of systemic corticosteroid , systemic chemotherapy or immunosuppresive drugs.
6)Patient with allergy to leeches.
7)Patient on anticoagulant medication.


Sample size- Total 30 


Diagnosed patients of vranagranthi from OPD and IPD of Ayurvedic rugnalaya and camps in the periphery of parent rugnalaya and  research center will be taken as sample.

Study group-Jalaukavacharan

Total duration of drug administration will be 21 days.The mode of drug administration will be by local route.

Follow up - follow up will be on 7th, 14th, 21st, 28th day.

Result- Result will be drawn as per assesment criteria & statistical analysis

 
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