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CTRI Number  CTRI/2023/02/049879 [Registered on: 20/02/2023] Trial Registered Prospectively
Last Modified On: 22/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Upanaha sweda (poultice)]  
Study Design  Single Arm Study 
Public Title of Study   Study the effect of Punarnavadi Upanaha (Poultice) sweda in Janusandhigatavata(Kneejoint Pain). 
Scientific Title of Study   A single arm clinical study to evaluate the efficacy of Punarnavadi Upanaha Sweda in the management of Janusandhigatavata. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Bondge 
Designation  MD Panchakarma 
Affiliation  Dr. D. Y. Patil College of Ayurved and Research Centre 
Address  Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  8329724807  
Fax    
Email  poojaabondge777@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pranesh Prakash Gaikwad 
Designation  MD Panchakarma 
Affiliation  Dr. D. Y. Patil College of Ayurved and Research Centre 
Address  Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  8149861142  
Fax    
Email  pranesh.gaikwad@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Bondge 
Designation  MD Panchakarma 
Affiliation  Dr. D. Y. Patil College of Ayurved and Research Centre 
Address  Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  8329724807  
Fax    
Email  poojaabondge777@gmail.com  
 
Source of Monetary or Material Support  
Dr.D.Y.Patil College of Ayurved and Research Centre,Pimpri,Pune 
 
Primary Sponsor  
Name  Dr.Pooja Bondge 
Address  Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 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 
Dr Pooja Bondge  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune  Department of Panchakarma OPD no 9 Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA 		 8329724807

poojaabondge777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-upanAhaH (niragniH), उपनाहः (निरग्निः) (Procedure Reference: Gadnigraha, Procedure details: Procedure Reference: Gadanigraha, Procedure details: (Procedure Reference: Gadanigraha, Procedure details: coarse power is taken roasted until light brown and then by adding kanji paste will be prepared paste will be applied over affected part uniformily of about 5mm thickness. It will be covered with proper shaped arka patra and then with cotton bandage for 6 hours. ))
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients in age group of 18 to 80 yrs.
Patient of Janusandhigatavata having classical signs & symptoms like shool(joint pain), shoth(joint swelling),akunchan prasaran kashtata(pain during movements) (ch.chi.28/37)

 
 
ExclusionCriteria 
Details  Patient with other joint disorders such as k/c/o Amavata & Vatarakta.
k/c/o Auto immune Diseases-Ankylosing Spondylitis
k/c/o Neoplasm.
Permanent joint Damage.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Punarnavadi Upanaha Sweda in the pain reduction of Janusandhigatavata using VAS scale  14 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of Punarnavadi Upanaha sweda in the management of joint restriction of Janusandhigatavata 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)   01/04/2023 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [poojaabondge777@gmail.com].

  6. For how long will this data be available start date provided 01-07-2023 and end date provided 01-07-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
It is the clinical study to evaluate the effect of punarnavadi upanah sweda in the management of Janusandhijatavata.

Study design is single arm  clinical study.

Total 32 patients will be enrolled .

Assesment of patients  1ST ,7TH Day.

Follow up on  14 th day.

Total duration of study will be 18 months.




 
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