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CTRI Number  CTRI/2022/04/041669 [Registered on: 05/04/2022] Trial Registered Prospectively
Last Modified On: 25/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic medicine for knee osteoarthritis. 
Scientific Title of Study   "Study The Efficacy Of Shunthibaladwaya Kashaya In The Management Of Janusandhigata Vata W.S.R To Knee Osteoarthritis." 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalini Negi 
Designation  PG Scholar 
Affiliation  DY Patil School of Ayurveda,Nerul ,Navi mumbai,Maharashtra 
Address  DY Patil School of Ayurveda,3rd floor, Dept. of Kayachikitsa, block no 10,DY Patil Vidyanagar,sector 7,Nerul-400706 Thane ,Maharashtra India

Thane
MAHARASHTRA
400706
India 
Phone  9568438414  
Fax    
Email  shalini.lingwal1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dnyaneshwar M Padavi 
Designation  H.O.D And Professor 
Affiliation  DY Patil School of Ayurveda,Nerul ,Navi mumbai,Maharashtra 
Address  DY Patil School of Ayurveda,3rd floor,Dept of Kayachikitsa,block no 10,DY Patil Vidyanagar,sector 7,Nerul-400706 Thane ,Maharashtra India

Thane
MAHARASHTRA
400706
India 
Phone  9833158688  
Fax    
Email  dmpadavi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dnyaneshwar M Padavi 
Designation  H.O.D And Professor 
Affiliation  DY PATIL School of ayurveda,Nerul ,Navi mumbai,Maharashtra 
Address  DY PATIL School of ayurveda,3rd floor,Dept of Kayachikitsa,block no 10,DY PATIL Vidyanagar,sector 7,Nerul-400706 Thane ,Maharashtra India

Thane
MAHARASHTRA
400706
India 
Phone  9833158688  
Fax    
Email  dmpadavi@gmail.com  
 
Source of Monetary or Material Support  
DY PATIL School of Ayurveda and Hospital, DY Patil Vidyanagar sec 7 nerul-400706 
 
Primary Sponsor  
Name  Dr Shalini Negi 
Address  Millenium Tower ,B3 building Sector 9 Sanpada, Navi Mumbai 
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 Shalini Negi  DY Patil school of ayurveda  DY PATIL School of ayurveda,3rd floor,Dept of Kayachikitsa,block no 10,DY PATIL Vidyanagar,sector 7,Nerul-400706 Thane ,Maharashtra India
Thane
MAHARASHTRA 		 9568438414

shalini.lingwal1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  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 ArmDrugClassical(1) Medicine Name: Shunthibaladwaya Kashaya, Reference: Shastrayogam, kashaya prakaran, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.patient having 30 to 70 years of either sex will be selected for study
2.clinical sign and symptoms of diagnosed patient of janu sandhigata vata will be selected i.e janusandhishool (pain in knee joint), shoth(swelling),stambha(swelling),vaatpurnadruti(crepitation) sparsh,restricted movement of knee joint 
 
ExclusionCriteria 
Details  1. patient less than 30 years and more than 70 years
2. gouty arthritis
3. Rheumatoid arthritis
4. previous surgery on knee joint/traumatic joint injuries
5.heart disease/renal disease
6.hypertensive
7.pott,s spine/infection
8.pregnant and lactating mother 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
subjective assessement i.e Sandhishool,shoth,stambh,vatapurnadritisparsh
objective criteria i.e. range of motion ,Radiological assessement 		 Day1,Day15,Day30,Day45,Day60 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   18/04/2022 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    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 [shalini.lingwal1@gmail.com].

  6. For how long will this data be available start date provided 18-04-2022 and end date provided 14-08-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

 TITLE OF DISSERTATION

“STUDY THE EFFICACY OF SHUNTHIBALADWAYA KASHAYA IN THE MANAGEMENT OF JANU SANDHIGATA VATA W.S.R TO KNEE OSTEOARTHRITIS”

                                                  AIM AND OBJECTIVES

 

AIM:

*      To study the efficacy of Shunthibaladwaya Kashaya in the management of Janu Sandhigata Vata W.S.R to knee osteoarthritis.

 

 

OBJECTIVES:

*      To study the Janu Sandhigata Vata in Ayurvedic and modern aspects in detail.

 

*      To evaluate the efficacy of Shunthibaladwaya Kashaya in the management of Janu Sandhigata Vata.

 RESEARCH QUESTION

 

*      Primary Research Question: Is Shunthibaladwaya Kashaya effective in the management of Sandhigata Vata.?

 

*      Secondary Research Question: Is Shunthibaladwaya Kashaya safe in the management of Sandhigata Vata.?

 HYPOTHESIS

 

           Null Hypothesis (H0):

*      Shunthibaladwaya Kashaya is not effective in the management of Janu Sandhigata Vata.

 

           Alternate Hypothesis (H1):

*      Shunthibaladwaya Kashaya is effective in the management of Janu Sandhigata Vata.

DI  DIAGNOSTIC CRITERIA

Janusandhishool(paininkneejoint),shoth(swelling),stambha(stiffness),vaatpurnadrutisparsh(crepitus),restricted movement of knee joint.

data collection relevant to objectives:

Patient: A detailed Case record form including all the classical sign and symptoms of Janu Sandhigata Vata will be prepared. Data about basic demography like age, sex, occupation, diet etc. will be collected & data about subjective criteria will be completed after clinical examination of the patients

SOP OF SHUTHIBALADWAYA KASHAYA-

Raw materials of Shunthi ,Bala,and Atibala will be purchase from local Ayurveda market and will be authenticated and standardize in GMP certified center.

Sunthibaladwaya kashaya will be prepared as per reference of sharangdharsanhita, madhayam khand ,similarly we will be taking 5 gm of each ingrediants(i.e 15 gm of bharad or churna)& 16 parts of water(240 ml) which will be reduced to 1/8 of liquid(30 ml)after simmering or cooking on a low flame.

 

DOSE- 30 ml BD after food

Anupan- warm water

 

 

 

 

 
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