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CTRI Number  CTRI/2018/06/014459 [Registered on: 07/06/2018] Trial Registered Prospectively
Last Modified On: 06/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of some ayurvedic medicine in the management janu sandhigata vata (Osteoarthritis of Knee Joint 
Scientific Title of Study   Comparative Study of Adityapaka Guggulu with Janu Basti and Sandhivatari Gutika with Janu Basti in the Management of Janusandhigata Vata with special reference to Osteoarthritis of Knee Joint 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Ram Kishor Joshi 
Designation  Professor and Head of the Department 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Kayachikitsa National Institute of Ayurveda Jorawar Singh Gate , Madhav Villas Palace , Amer Road Jaipur Rajasthan 302002 India
Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India
Jaipur
RAJASTHAN
302002
India 
Phone  9414322297  
Fax    
Email  joshirk1964@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Ram Kishor Joshi 
Designation  Professor and Head of the Department 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Kayachikitsa National Institute of Ayurveda Jorawar Singh Gate , Madhav Villas Palace , Amer Road Jaipur Rajasthan 302002 India
Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India
Jaipur
RAJASTHAN
302002
India 
Phone  9414322297  
Fax    
Email  joshirk1964@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bijay Shrestha 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Kayachikitsa National Institute of Ayurveda, Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India
Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India
Jaipur
RAJASTHAN
302002
India 
Phone  9079854761  
Fax    
Email  doc.bijay@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India  
Type of Sponsor  Research institution and hospital 
 
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 
Prof Ram Kishor Joshi  National Institute of Ayurveda Hospital  OPD room no 1, 18, 25 PG Department of Kayachikitsa, Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 India
Jaipur
RAJASTHAN 
9414322297

joshirk1964@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Janusandhigata vata ( osteoarthritis of knee joint),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adityapaka Guggulu with janu basti  Adityapaka Guggulu 2 tablets (each tablet of 500mg)twice daily after meal with luke warm water for 30 days with Janu basti daily for 45 minutes for 14 days with Nirgundi tailam 
Comparator Agent  Sandhivatari gutika with janu basti  Sandhivatari gutika 2 tablets (each tablet of 500mg) twice daily with warm water after meal for 30 days with Janu basti daily for 45 minutes for 14 days with Nirgundi tailam. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i. Patient willing to sign the consent form.
ii. Patients between the ages of 30-60 years of either sex.
iii. Patients with signs and symptoms of Janusandhigata Vata.
iv. Patients with OA changes in X-ray.
v. Patients with chronicity of less than 5 years.

 
 
ExclusionCriteria 
Details  i. Patients suffering from paralysis.
ii. Patients of rheumatoid arthritis, gout, ankylosing spondylitis and traumatic arthritis.
iii. Patients having septic arthritis, tuberculosis, brucellosis, pyogenic osteomyelitis, etc.
iv. Patients having malignancy and other complicated diseases like Congestive Cardiac Failure (CCF), Diabetes Mellitus, Malignant Hypertension, etc.
v. Patients having severe osteoarthritic changes.
vi. Patients with bony deformity.
vii. Pregnant and lactating mother.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patients of either sex of 30 to 60 years old diagnosed as Janu sandhigata vata (Osteoarthritis of knee joint) will be selected for relief in sign and symptoms.  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
to compare the efficacy of Adityapaka Guggulu with Janu Basti and Sandhivatari Gutika with Janu Basti in the Management of Janusandhigata Vata with special reference to Osteoarthritis of Knee Joint.  30days 
 
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   Phase 2 
Date of First Enrollment (India)   25/08/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  


Osteoarthritis is the most prevalent form of arthritis in India, affecting over 15 million adults every year. It is the disease of old age and by 2020, the number of 65 years and above population in India is likely to be about 177 million. India may become the osteoarthritis capital of the world with over 60 million cases of the diseases by 2025. Despite the advancement in using new drugs and techniques, the management of Osteoarthritis with analgesics, corticosteroids and surgical procedure (total knee replacement) in Allopathic medicine is either temporary or very costly and also having many side effects. Ayurveda is the best alternative option. In Ayurveda, Sandhigata Vata is managed by Snehana, Swedana, Upanaha and Vata Shamak drugs. Among the wide varieties of drugs mentioned in Ayurveda text books, Adityapaka Guggulu and Sandhivatari Gutika have been chosen for the study so as to re-establish their efficacy which may contribute to the successful treatment of Sandhigata Vata (OA). Adityapaka guggulu which has been mentioned invVatavyadhi prakaran of Chakradatta contains triphala, pipplai, tvak, ela and guggulu processed in dashmool kvatha. Similarly, Sandhivatari Gutika which has been mentioned in Uttarkhanda, Amavata Chikitsha of Rasachandansu contains rakta bola, hingula and guggulu. The contents of these drugs are easily available and cheaper. They are easy to use as there is no special measure or precaution that needs to be taken during their administration. The efficacy of these two drugs will be assessed and compared. In both cases Janu Basti with Nirgundi tailam will also be done.






 
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