| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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 |