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CTRI Number  CTRI/2024/08/071761 [Registered on: 01/08/2024] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trail to compare and study the effect of Panchatikta Ghruta Guggulu in the Management of Osteoarthritis in Postmenopausal Women 
Scientific Title of Study   Efficacy of Panchatikta Ghruta Guggulu in the Management of Osteoarthritis in Postmenopausal Women -A Randomized controlled Trial 
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 Uma Shetti 
Designation  Reader 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi 
Address  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur, Belagavi, Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  9738467051  
Fax    
Email  dr.umashetti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Basavaraj Tubaki 
Designation  Professor 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi 
Address  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnatak
Department of Kayachikitsa KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnatak
Belgaum
KARNATAKA
590003
India 
Phone  9448634660  
Fax    
Email  ayurbasavaraj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Basavaraj Tubaki 
Designation  Professor 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi 
Address  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnatak
Department of Kayachikitsa KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnatak
Belgaum
KARNATAKA
590003
India 
Phone  9738467051  
Fax    
Email  ayurbasavaraj@gmail.com  
 
Source of Monetary or Material Support  
KLE Ayurveda Hospital and Medical Research Centre A Multispeciality Teaching Hospital of KLE Academy of Higher Education and Research Shahapur Belagavi Karnataka 590003 
 
Primary Sponsor  
Name  KLE Ayurveda Hospital and Medical Research Centre 
Address  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnatak 
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 
Dr Uma Shetti  KLE Ayurveda Hospital Shahapur Belagavi  OPD and IPD department of Kayachikitsa,OPD room No:6 KLE Shri B M K Ayurveda Hospital Shahapur Belagavi Karnatak 590003
Belgaum
KARNATAKA 		 9738467051

dr.umashetti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER Ethical Committee(Human) for Ph.D. Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M17||Osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, (2) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, (3) ICD-10 Condition:M171||Unilateral primary osteoarthritisof knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: PanchatiktaGhritaGuggulu, Reference: AstangaHrudayaChikitsaSthana, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: water), Additional Information: -
2Comparator Arm (Non Ayurveda)-Tab. Etoricoxib60 mg / once a day / after food with water for 60 days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1.Subjects aged between 40 - 60 years.
2.Patients with classical presentations of Sandhigata vata and rajonivrutta stri will be selected irrespective of their religion and occupation.
3.Subjects fulfilling the diagnostic criteria & diagnosed previously (As per American college of Rheumatology (ACR) classification criteria for OA of the Knee).
4.Affected knee joint - Single or Both
5.Subject who submit a written informed consent.
6.One month after the completion of participation in any other clinical trial 
 
ExclusionCriteria 
Details  1.Severe arthritis1.(KL grade IV)
2.Patients with RA, Gout, Osteoporosis and other musculoskeletal system disorders
3.Known cases of secondary OA due to tuberculosis (TB), syphilis, aids and leprosy
4.Gross disability like bedridden and confined to wheel chair
5.Patients with other major systematic disorders which interfere with the treatment will be excluded like uncontrolled DM
6.Patients with .Significant knee injury within past 6 months; presence of a rash or open 6.wound over the knee.
7.Use of NSAID’s, Analgesics, Intra articular steroid injections within the past period of 30 days
8.Patients with history of knee surgery or arthroscopy within the past year; knee replacement on study knee
9.Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in Janu sandhi shoola (Knee osteoarthritic pain) i.e WOMAC28 (Western Ontario and Mc-Master University Osteoarthritis Index) and VAS29 Scale   baseline and at 30th ,60th days 
 
Secondary Outcome  
Outcome  TimePoints 
–Changes on walking speed
–Changes in Serum Calcium & alkaline phosphatase
–Changes in inflammatory markers (IL 6 & TNF alpha)
–Changes in Range of Motion : Goniometric assessment
–Changes in Quality of Life (QoL): Short Form-36  		 –from baseline & at 30th ,60th days
– from baseline & in 60 days
–from baseline & in 60th days
–at baseline & at 30th, 60th days
– at baseline & at 30th, 60th days 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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)   30/08/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 chronic degenerative disorder of multifactorial etiology characterized by the loss of articular cartilage. Menopause has a multitude of effects that affect knee OA, including hormonal shifts, loss of bone mineral density, muscle loss and tendon strength and this common musculoskeletal condition particularly afflicts women in menopause. India is expected to be the chronic disease capital with 60 million people with arthritis by 2025, and prevalence is about 22% to 39%, globally affecting 18% 0f woman over the age of 60.It appears that osteoarthritis in men and women may have different pathogenesis mechanism. Experimental and clinical studies strongly support a link between the increased state of proinflammatory cytokine activity and postmenopausal bone lossThere are studies showing that postmenopausal women have elevated serum levels of proinflammatory cytokines, especially IL-6 and TNF-α.alliative management for Knee Osteoarthritis include NSAIDs and Opioids as mainstays of pharmacotherapy, even Knee Replacement is another option in managing Osteoarthritis. Etoricoxib  seem to be the most effective oral NSAIDs for pain and function in patients with osteoarthritis.But still there are some limitations with adverse effects furthermore; there are no proven disease-modifying therapies for osteoarthritis. Thus, Preventive measures previously addressed need to be reaffirmed throughout the world so that we will effectively reduce the future burden and disability of OAWith this background here is an attempt made to find out the role of ayurveda formulation in management of  osteoarthritis in postmenopausal woman. So the herbomineral compound Panchatikta gruta Gugguluformulation explained in the classics for the treatment of sandhigata vata (osteoarthritis) has been selected for the present study.Hence, the current research has been planned to evaluate the efficacy of Panchatikta Ghruta Guggulu  in the management of osteoarthritis in post menopausal woman through assessing changes in pain, inflammation,  joint mobility, bone metabolism and  quality of life 
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