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CTRI Number  CTRI/2024/05/066884 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To see the efficacy of kulattha Pinda sweda in the management of janusandhigatavata (osteo-arthritis of knee joint)  
Scientific Title of Study   A Single Arm Clinical Study to evaluate the efficacy of Kulattha Pinda Sweda in the management of janusandhigatavata (Knee-Osteoarthitis) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Parth Kapil 
Designation  MD PG Scholar 
Affiliation  Dr.D.Y.Patil College of Ayurveda and Research centre,Sant Tukaram Nagar,Pimri,Pune,Maharastra 
Address  OPD Number 9,Department of Panchakarma,Dr.D.Y.Patil College of Ayurveda and Research centre,Sant Tukaram Nagar,Pimri,Pune,Maharastra 411018 Pune Maharastra India

Pune
MAHARASHTRA
411018
India 
Phone  9914619277  
Fax    
Email  kapilparth@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pranesh P Gaikwad 
Designation  Associate Professor 
Affiliation  Dr.D.Y.Patil College of Ayurveda and Research centre,Sant Tukaram Nagar,Pimri,Pune,Maharastra 
Address  OPD Number 9,Department of Panchakarma,Dr.D.Y.Patil College of Ayurveda and Research centre,Sant Tukaram Nagar,Pimri,Pune,Maharastra 411018 Pune Maharastra India

Pune
MAHARASHTRA
411018
India 
Phone  8668259365  
Fax    
Email  pranesh.gaikwad@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Pranesh P Gaikwad 
Designation  Associate Professor 
Affiliation  Dr.D.Y.Patil College of Ayurveda and Research centre,Sant Tukaram Nagar,Pimri,Pune,Maharastra 
Address  OPD Number 9,Department of Panchakarma,Dr.D.Y.Patil College of Ayurveda and Research centre,Sant Tukaram Nagar,Pimri,Pune,Maharastra 411018 Pune Maharastra India

Pune
MAHARASHTRA
411018
India 
Phone  8668259365  
Fax    
Email  pranesh.gaikwad@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr.D.Y.Patil College of Ayurveda and Research Centre,Sant Tukaram Nagar,Pimpri,Pune,Maharastra 411018 
 
Primary Sponsor  
Name  Parth kapil 
Address  Dr.D.Y.Patil College of Ayurveda and Research Centre,Sant Tukaram Nagar,Pimpri,Pune,Maharastra 411018 
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 
DrParth kapil  Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune.  OPD Number 9,Department of Panchakarma,Dr.D.Y.Patil College of Ayurveda and Research centre,Sant Tukaram Nagar,Pimri,Pune,Maharastra 411018 Pune Maharastra India
Pune
MAHARASHTRA 		 9914619277

kapilparth@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR.DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE PIMPRI, PUNE-18  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: chakarpani samhita, Procedure details: In the vessel Kanji should be taken and Kulattha will be added in Kanji.kulattha is to be taken out and put in a cloth and tied in the form of Pinda (bolus).local oleation with tila taila will be done on affected janusandhi.Pinda bolus is to be used locally on the affected janusandhi for swedana for 20 minutes.After the procedure,paste of medicine remaining on the affected knee will be cleaned with luke warm water and cloth. Procedure duration is for 20 minutes per day for 7 days)
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with Janusandhigatavata having classical signs and symptoms as mentioned in charaka samhita shool(joint pain),shotha(joint swelling),Akunchan Prasaran vedana(pain during movements).
2. Known case of Knee osteoarthritis.
3.Patients in age group of 25 to 70 years. 
 
ExclusionCriteria 
Details  1.Patients with other joint disorders such as known case of amavata & vatarakta
2. Known case of Autoimmune diseases-ankylosing spondylitis.
3.known case of neoplasm.
4.known case of knee ligament tears.
5.known case of knee articular tears.
6.known case of permanent knee joint damage. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Kulattha Pinda Sweda in the pain reduction of Janusandhigatavata (Knee-Osteoarthritis) using VAS scale.  7 days  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of Kulattha Pinda sweda in the management of joint restriction of Janusandhigatavata (Knee-Osteoarthritis) using goniometric measurement.  7 days 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   15/05/2024 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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 efficacy of Kulattha Pinda Sweda in the management of Janusandhigatavata 
           (Knee-  Osteoarthritis)”

 Study Design - Single Arm Clinical Study

 No of Participants - 32

  Procedure – Kulattha Pinda sweda is to be used locally on the affected janusandhi for 20 minutes for 7 days. 

 Assesment will be done on 1st and 7th day.

 Duration of Study - 18 months

 
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