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CTRI Number  CTRI/2023/08/056875 [Registered on: 24/08/2023] Trial Registered Prospectively
Last Modified On: 23/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Vyadhishardula Guggulu Over Yogaraja Guggulu With Janubasti In Osteoarthritis.  
Scientific Title of Study   Single Blind Randomized Controlled Clinical Study To Evaluate The Effect Of Vyadhishardula Guggulu Over Yogaraja Guggulu With Janubasti In Janusandhigata Vata With Special Reference To Osteoarthritis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr manikantha M H 
Designation  BAMS MD 1st year Kayachikitsa 
Affiliation  DGM Ayurvedic Medical College, Hospital and PG and PhD Studies Gadag 
Address  DGM Ayurvedic Medical College, Hospital and PG and PhD studies, Kalasapur Road Near Shivanandamatha Gadag
Near Basava Mantapa Saraswathi Sadana Gadag 582103
Gadag
KARNATAKA
582103
India 
Phone  8073888144  
Fax    
Email  drmanikanthmh1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh N Belavadi 
Designation  BAMS MD (Ayu) Professor H O D of Kayachikitsa 
Affiliation  D G M Ayurvedic Medical College, Hospital and PG and PhD studies Gadag 
Address  D G M Ayurvedic Medical College, Hospital and PG and PhD studies, Khalsapur road near shivananda matha Gadag

Gadag
KARNATAKA
582103
India 
Phone  8073038115  
Fax    
Email  hardikasnb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manikanth M H 
Designation  BAMS MD 1st year Kayachikitsa 
Affiliation  D G M Ayurvedic Medical College, Hospital and PG and PhD studies Gadag 
Address  DGM Ayurvedic medical college and hospital PHD studies kalasapur road near shivananda matha gadag

Gadag
KARNATAKA
582103
India 
Phone  807388144  
Fax    
Email  drmanikanthmh1996@gmail.com  
 
Source of Monetary or Material Support  
D G M Ayurvedic Medical College and Hospital 
 
Primary Sponsor  
Name  Dr Manikanth M H  
Address  D G M Ayurvedic Medical college and Hospital, PG and PhD studies Gadag 582103 
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 Manikanth M H  Shree jagadguru shivanada hospital  D G M Ayurvedic Medical college and hospital PG and PhD studies and Research centre kayachikitsta department room.No.3 Gadag 582 103 KARNATAKA
Gadag
KARNATAKA 		 8073888144

drmanikanthmh1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL CLEARANCE COMMITTEE D G M AYURVEDIC MEDICAL COLLEGE AND HOSPITAL AND POST GRADUATE STUDIES GADAG  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 ArmDrugClassical(1) Medicine Name: Vyadhishardula, Reference: Amavatadikara, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Sukoshna jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Yogarajaguggulu , Reference: Amavatadikara, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Sukoshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects with classical signs and symptoms of Sandhigatavata like Vatapurata in sandhi, Druti sparshata of sandhi, Shotha in sandhi, While Prasarana akunchana vedana in sandhi.
Subjects of aged between 40-70 years of either sex.
Subjects willing and able to participate in the study.
Subjects who fit for Janubasti. 
 
ExclusionCriteria 
Details  Subjects suffering from systemic disorders as well as other known case if major illness.
Like Infective Arthritis.
Pregnant woman and Lactating mother.
Rheumatoid arthritis, Diabetes mellitus, Acute joint trauma, Complete Loss of Articular cartilage and Systemic lupus erythematosus. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvements may be noticed on clinical features of Janu Sandhigata vata with special reference to Osteoarthritis.symptoms like Knee Joint Pain, Crepitations, Tenderness.  0,7, 22, 52, 87th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Radiological improvements may be noticed   87th day 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/09/2023 
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="2"
Days="10" 
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 - NO
Brief Summary   Osteoarthritis is a degenerative joint disease that results from breakdown of joint cartilage and underlying bone. Osteoarthritis affects the entire joint and cause the changes in the bone and deterioration of the connective tissue that hold the joint together and attaches muscles to bone. It also causes inflammation of the joint lining. Most of the time osteoarthritis occurs in weight bearing joints that to knee joint. Osteoarthritis is the second most common Rheumatologic problem and it is the most frequent joint disease with prevalence of 22% to 39% in India and in Bangalore Prevalence rate 26.6%1 . Osteoarthritis is more common in women then man. Nearly 45% of women over the age of 65 years have symptoms while 70% of those over years shows radiological evidence of osteoarthritis. According to W.H.O. Osteoarthritis is 2nd most common Musculo skeletal disorder in this world signs and symptoms of the osteoarthritis includes joint pain, stiffness, tenderness, loss of flexibility, swelling and decreased range of motion. Contemporary system of medicine has conservative or surgical treatment which is more effective with some side effects. Intra articular steroid are widely using for marked relief from symptoms and oral pain killer. Habitual consumption of these causes side effects. Like gastric irritation, mucosal ulceration etc. Where as it can be better treated through Ayurvedic treatment modalities. In Janusandhigata vata there is increased Vata which brings Rukshata, Laghuta, Soushirya, and Kharatwa and destroys the function of joints. Janubasti is one among the Bahirparimarjana treatment modality of snehana and swedana effect with it’s drug combination therefore Janubasti with Ksheerabalataila and shamana aushadi provides desired effect. Ksheerabalataila contains Balamoola, Tilataila and Ksheera, all are having vatahara, brumhana, and opposite properties of vata. Vyadhishardula Guggulu ingredients like triphala, trikatu, katu taila, Guggulu, Musta, Vidanga, Guduchi, Chitraka, Nishotha, Danthi, Chavya, Surana, Manaka, Jatipala, Shuddha Parada, Shuddha Gandhaka, Loha bhasma, Abhraka bhasma all these drugs are having Anti inflammatory, Anti microbial, Analgesic, Rejuvenative action, Guggulu prevents the degenerative changes in bones and joints by considering these points study has been undertaken taken for the clinical trial. 
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