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CTRI Number  CTRI/2026/03/105731 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 06/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study the effect of Ayurvedic Medication on knee joint movement 
Scientific Title of Study   Randomized controlled comparative clinical study to evaluate the efficacy of Vatahar Ghanvati with Bala tail massage in osteoarthritis with special reference to functional changes in 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  DrArati Rameshwar Sawant 
Designation  PG Scholar Kayachikitsa Dept. 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 
Address  OPD No 13 Kayachikitsa OPD

Nashik
MAHARASHTRA
422003
India 
Phone  7030308452  
Fax    
Email  aratisawant15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSanjivani Nitin Rathod 
Designation  Assosciate Professor and Guide 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 
Address  OPD No 13 Kayachikitsa OPD

Nashik
MAHARASHTRA
422003
India 
Phone  8007229141  
Fax    
Email  sanjivanirathod431@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSanjivani Nitin Rathod 
Designation  Assosciate Professor and Guide 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 
Address  OPD No 13 Kayachikitsa OPD

Nashik
MAHARASHTRA
422003
India 
Phone  8007229141  
Fax    
Email  sanjivanirathod431@gmail.com  
 
Source of Monetary or Material Support  
Arogyashala Rugnalaya Ganeshwadi Panchavati Nashik 422003 
 
Primary Sponsor  
Name  Dr Arati Rameshwar Sawant 
Address  Arogyashala Rugnalaya Ganeshwadi Panchavati Nashik 422003 
Type of Sponsor  Other [Govt aided ayurvedic 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 
DrSanjivani Rathod  Aarogyashala Rugnalaya   OPD No 13 Kayachikitsa OPD
Nashik
MAHARASHTRA 
8007229141

sanjivanirathod431@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Ayurved Seva Sangh Ayurved mahavidyalaya, Nashik   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: Vatahar Ghanvati with Bala Tail Massage, Reference: Sahstrayog Sanghrah, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Bala Tail, Reference: Ashtang Hrudaya Vatvyadhichikitsa 21/73, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  patient irrespective of sex religion profession marital status and socio-economic status Patient showing symptoms of Janusandhigata Vat as Vatapurna Drutisparsh Pravrittich svedana shoath 
 
ExclusionCriteria 
Details  patients with congenital structural and functional deformity patients suffering from any type of joint deformities or systemic disorder which can
interfere with the treatment of janusandhigata vata as vatpurna drutisparsh pravruttich
savedana shoth pregnant women patient having hiv HBsAg autoimmune disorder etc 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduction in knee joint pain measured using visual analog scale
reduction in knee joint stiffness 
2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in swelling of knee joint
reduction in tenderness 
2 weeks 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   23/03/2026 
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="6"
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  
Knee osteoarthritis  is a common chronic articular disease worldwide. It is also the most common form of osteoarthritis and is characterized by high morbidity and disability rates With the gradual increase in life expectancy and ageing population, knee osteoarthritis not only affects the quality of life of patients but also poses a burden on global public health osteoarthritis is a disease of unknown etiology and complex pathogenesis. It commonly affects joints subjected to greater loads and higher levels of activity. The knee joint which is the most complex joint of the human body and bears the greatest load among all joints is therefore most susceptible to development of osteoarthritis Knee osteoarthritis lesions may involve articular cartilage synovium joint capsule and periarticular muscles causing irreversible articular damage.Factors such as mechanical overload, inflammation, metabolism, hormonal changes and ageing serve key roles in the acceleration of Knee osteoarthritis progression. The clinical diagnosis of knee osteoarthritis is primarily based on combined analysis of symptoms, signs, imaging and laboratory examination results. At present, there is no cure for knee osteoarthritis and the currently available therapies primarily focus on symptomatic treatment and delay of disease progression. Knee replacement surgery is typically performed in patients with advanced disease. The current study presents a review of epidemiological characteristics risk factors histopathological manifestations pathogenesis diagnosis treatment modalities and progress in knee osteoarthritis research. Sandhigata Vata is a type of Vata Vyadhi described in Ayurveda, characterized by the vitiation of Vata Dosha and its localization in the Sandhi joints leading to pain stiffness and restricted movements. When this condition specifically affects the knee joint Janu Sandhi, it is termed Janusandhigata Vata.In Charaka Samhita, the condition is described as Sandhigata Vata where the vitiated Vata lodges in the joints producing Shoola pain Shotha swelling and Prasarana Akunchana Vedana pain during flexion and extension along with Atopa crepitus Sushruta Samhita elaborates that in Sandhigata Vata, the joint appears enlarged Sandhi Shotha produces sound on movement and movement becomes painful and restricted  From a modern perspective Janusandhigata Vata can be correlated with osteoarthritis of the knee,a chronic degenerative joint disorder involving cartilage wear-and-tear, subchondral bone changes osteophyte formation and synovial inflammation. osteoarthritis is a leading cause of disability worldwide, particularly in the elderly population. The prevalence of knee osteoarthritis in India is rising due to increasing life expectancy sedentary lifestyle obesity and age related degeneration 
 
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