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CTRI Number  CTRI/2024/06/068885 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [curative]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of janu Basti And janu dhara with shudha Bala tail on two group of 20 patients of Janusandhigata vata w.s.r.to osteoarthritis of Knee joint  
Scientific Title of Study   A Comparative clinical study to Evaluate the efficacy of Janu Basti And Janu Dhara with Shudh Bala tail on Janusandhigata vata w.s.r.to Osteoarthritis of Knee joint.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrRanjeet kumar 
Designation  MD (Ay.) Scholar (Dept. of Panchkarma) 
Affiliation  Govt. Ayurvedic Medical College and Hospital 
Address  Department of Panchakarma Govt. Ayurvedic Medical College and Hospital, Kadamkuan, Patna-3, Bihar
Kadamkuan, Patna-3, Bihar
Patna
BIHAR
800003
India 
Phone  9504605847  
Fax    
Email  kr.ranjeetbams@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akhilesh Prasad Singh 
Designation  HOD & Asso. Prof. Dept. Of Panchkarma 
Affiliation  Govt. Ayurvedic College and Hospital 
Address  Govt. Ayurvedic College and Hospital, Kadamkuan, Patna-3, Bihar
OPD NO.11, Department of Panchkarma, Kadamkuan, Patna-3, Bihar
Patna
BIHAR
800003
India 
Phone  8002680973  
Fax    
Email  drapsinghpatna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhilesh Prasad Singh 
Designation  HOD & Asso. Prof. Dept. Of Panchkarma 
Affiliation  Govt. Ayurvedic Medical College and Hospital 
Address  Govt. Ayurvedic College and Hospital, Kadamkuan, Patna-3, Bihar
OPD NO.11, Department of Panchkarma, Government Ayurvedic College and Hospital, Kadamkuan, Patna-3, Bihar
Patna
BIHAR
800003
India 
Phone  8002680973  
Fax    
Email  drapsinghpatna@gmail.com  
 
Source of Monetary or Material Support  
Govt. Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar- 800003, India Kadamkuan, Patna-3, Bihar  
 
Primary Sponsor  
Name  Dr Ranjeet Kumar 
Address  Department of Panchakarma Govt. Ayurvedic College and Hospital, kadamkuan, Patna, Bihar- 800003 Kadamkuan, Patna-3, Bihar  
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 Ranjeet Kumar  Govt. Ayurvedic Medical College and Hospital  Department of Panchakarma Govt. Ayurvedic College and Hospital, Kadamkuan, Patna-3, Bihar
Patna
BIHAR 		 9504605847

kr.ranjeetbams@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (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 ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Susruta Samhita Chilkitsasthana 4, Procedure details: patient will be made to sit in sitting position with legs straight and then the boundary will be prepared over knee joint using black grams dough. and bala tail will be poured in it for 30 mins in luke warm condition. )
(1) Medicine Name: bala tail, Reference: Sahasra yogam, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 14 Days
2Comparator ArmProcedure-sekaH, सेकः (Procedure Reference: Susruta Samhita Chikitsasthana 4, Procedure details: Procedure details: patient will be made to sit in sitting position with legs straight and then bala tail will be poured in a stream over the knee joint for 30 mins in luke warm condition. ))
(1) Medicine Name: bala tail, Reference: sasra yogam, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age 40 to 70 years, irrespective of sex, religion and socio-economic status
-Patients having clinical features of Sandhigata Vata as described in Ayurvedic scriptures i.e. knee joint pain, oedema, crepitus, stiffness, tenderness, as well as clinical features of Osteoarthritis of knee.
-Patients fit to undergo Janu Basti and janu Dhara therapy, and willing to sign the Informed Consent.
 
 
ExclusionCriteria 
Details  -Age less than 40 years and more than 70 years Infective Arthritis, Gout, Ankylosing Spondylitis
-Subjects with any other serious systemic disorder.
-which may interfere with the treatment Traumatic causes like fracture Pregnancy and Lactation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The assessment will be carried out on the basis of improvement in objective and subjective parameters. Subjective parameteters symptoms- Knee joint pain,oedema,crepitus,stiffness,tenderness.  6o days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement of walking distance, Improvement in the range of motion of knee joint movement. changes in the knee joint x-ray  60 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   26/06/2024 
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="0"
Months="8"
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 - 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 -  Statistical Analysis Plan
    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 [kr.ranjeetbams@gmail.com].

  6. For how long will this data be available start date provided 26-06-2025 and end date provided 26-06-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   this study is a randomized ,open, parallel group, interventional prospective trial comparing the effectiveness of janu basti and janu dhara with shudha bala tail on janusandhigata vata w.s.r,to osteoarthritis of knee joint, that will be conducted in Government Ayurvedic Medical College and Hospital at Patna, Bihar in the Panchkarma department.. In each group of 20 patients janu basti will be done and in another group og 20 patients janu dhara will be done for 14 days once daily.Post intervention follow-up will be done every 15 days for total duration of study i.e. of 60 days.  
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