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CTRI Number  CTRI/2021/07/034964 [Registered on: 19/07/2021] Trial Registered Prospectively
Last Modified On: 11/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   “A prospective study of Osteoarthritis Knee (Janugat Sandhivata)” 
Scientific Title of Study
Modification(s)  		 “A prospective community based study for the evaluation of Yograj Guggulu, Ashwagandha Churna and Narayana Taila in Osteoarthritis Knee (Janugat Sandhivata)” 
Trial Acronym  Osteoarthritis Knee(Janugat Sandhivata) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kalpana B Kachare 
Designation  Research Officer(AYU) 
Affiliation  Central Council for Research in Ayurvedic Sciences , New Delhi 
Address  CCRAS-HQ, Janankpuri, New Delhi

South West
DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpana B Kachare 
Designation  Research Officer(AYU) 
Affiliation  Central Council for Research in Ayurvedic Sciences , New Delhi 
Address  CCRAS-HQ, Janankpuri, New Delhi


DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kalpana B Kachare 
Designation  Research Officer(AYU) 
Affiliation  Central Council for Research in Ayurvedic Sciences , New Delhi 
Address  CCRAS-HQ, Janankpuri, New Delhi


DELHI
110058
India 
Phone  09834410028  
Fax    
Email  kachare.kalpana@gmail.com  
 
Source of Monetary or Material Support  
Central council for Research in Ayurvedic Sciences, new Delhi, CCRAS-HQ, 2nd Floor, 61-65, Opposite to D block, Institutional Area, Janakpuri, New Delhi-110058 
 
Primary Sponsor  
Name  Ministry of Tribal Affairs 
Address  New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A K Sinha  Regional Ayurveda Research Institute, Gangtok  Dr A K Sinha, Research Officer Ayu, Regional Ayurveda Research Institute, Gangtok, THCRP Room Tadung, Gangtok, Sikkim-737102
South
SIKKIM 		 9466448410

drashoksinha22@gmail.com 
DR Ragvendra Naik   Central Ayurveda Research Institute, Bangalore  DR Ragvendra Naik, Research officer, Ayu Central Ayurveda Research Institute, Bangalore, THCRP Room, #12, Uttarahalli Manavarthe Kaval, Uttarahalli (Hobli), Bangalore South (Tq.) Kanakapura Main Road, Talaghattapura Post, Be ngaluru - 560109
Bangalore
KARNATAKA 		 9447755650

ayuraghu@gmail.com 
Dr P Panda  Central Ayurveda Research Institute, Bhubaneswar  Dr P Panda, Research Officer Ayurveda, Central Ayurveda Research Institute, Bhubaneswar, THCRP Room, Bharatpur, Near Kalinga Studio, Dist- Khorda, Bhubaneswar-751029 (Odisha)
Khordha
ORISSA 		 9777852889

pandapurnendu02@yahoo.com 
Dr Ekta   Central Ayurveda Research Institute, Guwahati  Dr Ekta , Research officer Ayu, Central Ayurveda Research Institute Guwahati THCRP Room, Borsojai, Beltola, Dist-kamarup Guwahati-781028 ASSAM
Kamrup
ASSAM 		 7696863979

dr.ektadogra@gmail.com 
Dr P Srinivas  Dr.AchantaLakshmipathi Regional Ayurveda Research Institute, Chennai  Dr P Srinivas, Research Officer Ayurveda, Dr.Achanta Lakshmipathi Regional Ayurveda Research Institute, Chennai, THCRP Room, 2nd Floor, VHS Hospital Campus, Taramani, Chennai, Tamilnadu. PIN: 600 113
Chennai
TAMIL NADU 		 9840879433

drsrinivaspitta@gmail.com 
Dr Monika Kumari  M.S. Regional Ayurveda Research Institute Jaipur,  Dr Monika Kumari, Research Officer-Ayu, M.S. Regional Ayurveda Research Institute (RARI), THCRP Room, Indira Colony, Bani Park, Jhotwara Road, Jaipur-302016
Jaipur
RAJASTHAN 		 7597117008

dr.monika1981@gmail.com 
Dr Rohit Kumar Rawate  Regional Ayurveda Research Centre, Tripura  Dr Rohit Kumar Rawate, Research Officer Ayurveda Regional Ayurveda Research Centre, Tripura THCRP Room,135, Ramnagar Road, No.4,Opp. Raj Bhandar Agartala, Tripura – 799002
South Tripura
TRIPURA 		 9007729430

rohitkravte@rediffmail.com 
Dr S B Singh  Regional Ayurveda Research Institute Gwalior  Dr S B Singh Research officer Ayu Regional Ayurveda Research Institute Gwalior, THCRP Room, Amkhoh, Gwalior, Madhya Pradesh 474001
Gwalior
MADHYA PRADESH 		 9782560296

dr.shyam84@yahoo.in 
Dr Vipin Sharma  Regional Ayurveda Research Institute Jammu  Dr Vipin Sharma, Research officer Ayurveda, Regional Ayurveda Research Institute Jammu THCRP Room, Rajinder Nagar,BanTalab, Jammu-181123
Jammu
JAMMU & KASHMIR 		 9899437195

Sharma.vipin@nic.in 
Dr K Nishanth   Regional Ayurveda Research Institute Vijayawada  Dr K Nishanth Research Officer Ayu, Regional Ayurveda Research Institute Vijayawada THCRP Room, New Rajiv Nagar, Payakapuram Vijayawada- 520015 Andhra Pradesh
Krishna
ANDHRA PRADESH 		 09946307403

dr.nishanth.k@gmail.com 
Dr Anil Avhad  Regional Ayurveda Research Institute, Ahmedabad   Dr Anil Avhad, Research Officer Ayu, Regional Ayurveda Research Institute, Ahmedabad, THCRP Room Block A & D, 2nd Floor, Bahumali Bhavan, Manjushree Mill Compound, Near Girdharnagar Over Bridge, Asarwa, Ahmedabad-380004
Ahmadabad
GUJARAT 		 9510176085

anilavhad4u@yahoo.com 
Dr U R Sekhar Namburi  Regional Ayurveda Research Institute, Nagpur  Dr U R Sekhar Namburi Research Officer Ayu Regional Ayurveda Research Institute, Nagpur THCRP Room, Near Gharkul Parisar, Near Venkatesh Nagar, NIT Complex Nandanwan, Nagpur – 440009 (Maharashtra)
Nagpur
MAHARASHTRA 		 8055595355

shilpasekhar2k5@yahoo.com 
Dr Vimal Tiwari  Regional Ayurveda Research Institute, Patna  Dr Vimal Tiwari, Research Officer Ayu Regional Ayurveda Research Institute, Patna THCRP Room, RMRI Building “D” Block, Agamkuan, Patna-800007,
Patna
BIHAR 		 8176811914

vimalayuccras@gmail.com 
Dr Akash Lal   Regional Ayurveda Research Institute, Port Blair  Dr Akash Lal , Research Officer Ayurveda Regional Ayurveda Research Institute, Port Blair, Quarter No. NGII - 1/3, Chakkargaon (PO), Opp. Municipal Complex, Near Ganesh Temple, Chakkargaon, Port Blair, South Andaman-744112,
Andamans
ANDAMAN & NICOBAR ISLANDS 		 9447755650

akashlalm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Institutional Ethical Committee- Central Ayurveda Research Institute Bhubaneshwar  Approved 
Institutional Ethical Committee- Central Ayurveda Research Institute Guwahati  Approved 
Institutional Ethical Committee-Central Ayurveda Research Institute Bangalore  Approved 
Institutional Ethical Committee-Central Ayurveda Research Institute Guwahati (For THCRP-Tripura)  Approved 
Institutional Ethical Committee-M. S. Regional Ayurveda Research Institute Jaipur   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Ahmadabad  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Chennai   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Gangtok  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Gwalior  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Jammu  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Nagpur   Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Patana  Approved 
Institutional Ethical Committee-Regional Ayurveda Research Institute Vijayawada  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: Janugat Sandhivata,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ashwagandha Churna   Ashwagandha Churna (API – Part I, Vol.-I). Dose: 3 gm twice daily Dosage form :Churna Route of Administration: Orally Time of Administration: Twice a day after food Anupana : water Duration of therapy:12 weeks  
Intervention  Narayan Taila  Narayan Taila (AFI–Part I, 8 : 23). Dose : 10 ml twice daily Dosage form : Taila Route of Administration: Local application Time of Administration : Twice a day at 12 hrs interval Duration of therapy : 12 weeks  
Comparator Agent  Not Applicable  Not applicable 
Intervention  Yograj Guggulu   Yograj Guggulu (AFI – Part I, 5 : 7). Dose :1gm (2 Tablets) twice daily Dosage form :Tablet of 500 mg each Route of Administration: Orally Time of Administration: Twice a day after food. Anupana :Lukewarm Water Duration of therapy :12 weeks  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participant of any gender in the age group 40-65 yrs of Scheduled Tribe community
2. Participant who are willing to provide written consent.
3. Participant of primary Osteoarthritis knee (Unilateral/ bilateral) as per any one of the following three ACR diagnostic criteria
 
 
ExclusionCriteria 
Details  i. Diagnosed cases of Rheumatoid arthritis or other type of inflammatory arthritis or patients who report to have been under anti-arthritic medication for RA or inflammatory arthritis.
ii. Participant prescribed Joint replacement surgery.
iii. Participant with history of trauma to the afflicted joint.
iv. Use of ambulatory aids such as wheel chair, walker etc
v. Someone who has BMI≥32kg/m² at the screening visit.
vi. Co-morbid conditions such as past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
vii. Known case of Renal/ Hepatic / Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease, Uncontrolled DM or HTN
viii. Pregnant women/ women who are planning for conception/lactating women
ix. Patient taking participation in any other clinical trial.
x. Any other condition which the P.I. thinks may jeopardize the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
i. Changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total score, Indian WOMAC (Modified –CRD Pune Version)   i. At Baseline, End of 4th week, End of 8th week, End of 12th Week, and End of 16th week. 
 
Secondary Outcome  
Outcome  TimePoints 
i. Change in the Visual Analogue Scale for pain
ii. Assessment of changes in Ayurvedic disease specific symptoms of sandhivata(sandhishula , Sandhishotha,Akunchana prasaranayoh vedana,Stambha,sandhisphutana )
iii. Frequency of use of no. of NSAID/analgesic medication
iv. Change in WOMAC Pain,stiffness,physical activity score
v. Tolerability assessed by proportion of recruited participants remaining in the trial intervention, during the trial.
 		 at baseline, 4th, 8th,12th week and end of the 16th week 
 
Target Sample Size   Total Sample Size="490"
Sample Size from India="490" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="490" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/07/2021 
Date of Study Completion (India) 21/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 under processed 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

1.    Objectives of the Study  :

·Primary objective- To assess the role of Ayurvedic formulations Yograj Guggulu, Ashwagandha Churna and Narayan Taila in the subjective outcomes of Osteoarthritis Knee (Sandhigat Vata).

·Secondary objective-

i)       To assess the role of the intervention in disease specific symptoms.

ii)     To evaluate the tolerability of Ayurvedic formulation Yograj Guggulu, Ashwagandha Churna and  Narayan Taila in the management of Osteoarthritis Knee.

 

2.      Study Design : Interventional

3.      Sample Size: 490 ( i.e. 35 each centre) Total Study participating centers-14

4.      Duration of Study : 10 Month

5.      Interventions : Yograj Guggulu, Ashwagandha Churna and  Narayan Taila

 

6.       Study initiated on -20th July 2021

7.       Study Completed on -21st March 2022

8.       Number of Cases Enrolled- 490

9.       Number of cases Completed- 483

10.   Number of Drop outs- 07


 
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