Effectiveness of Yavagodhumadi Upanaha Swedana in comperison to Koladi Upanaha Swedana and 1% topical Diclofenac gel in Janu Sandhigatavata (Osteoarthritis of knee)

Phase 3

Not yet recruiting

Conditions: Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,

Registration Number: CTRI/2022/04/041630

Lead Sponsor: Abhishek Bhattacharjee

Brief Summary: *Sandhigatavata* is the commonest type of joint disorder seen in clinical practice and the incidence increases with aging due to *Dhatu Kshaya* and *Vata* *Vriddhi*. The similar condition in modern contemporary system of medicine has been termed as Osteoarthritis. It is the commonest cause of locomotor disability specially in the elderly population and is the result of aging, trauma and bio-mechanical stress over the joint leading to loss of articular cartilage. Different internal medications as well as external therapies has been mentioned in different Ayurvedic classical texts for this condition. *Upanaha* which is said to be the best *Swedana* procedure for *Vataja* disorders has also been mentioned as one of the best external therapies for *Sandhigatavata. T*he present research work is planned to evaluate the clinical efficacy of *Yavagodhumadi* *Upanaha Swedana*in managing the pain of *Janu Sandhigatavata* (Osteoarthritis of knee). As *Koladi Upanaha* has been found effective in the management of *Janu Sandhigatavata* in different clinical trials, so the efficacy of *Yavagodhumadi Upanaha* will be compared with *Koladi Upanaha*. Again 1% topical Diclofenac gel has been found to be effective in the management of pain of knee osteoarthritis, improves physical function so considered as one of the first line management for osteoarthritis of knee. Seeing these it also has been taken as a control drug to compare the efficacy of *Yavagodhumadi Upanaha. So, in the present study the effectiveness of Yavagodhumadi swedana will be compared with Koladi upanaha swedana and 1% topical Diclofenac sodium gel in the management of Janusandhigata vata.*The present study is a randomized, researcher blind three arm interventional comparative clinical trial of 30 days duration where 70 patients will be allocated in each group (total 210 patients in 3 groups) following inclusion and exclusion criteria. In this study the effectiveness of an Ayurvedic external therapy (*Yavagodhumadi Upanaha Swedana*) will be compared to a similar therapy (*Koladi Upanaha Swedana*) and 1% topical Diclofenac sodium gel for superior effectiveness. Evaluation assessments will be done at base line (0-day), 15th day and 30th day (completion). Assessment will be done based on standard subjective and objective parameters. Result will be analyzed statistically.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 210

Inclusion Criteria

1.Patient who are willing to participate in the study and ready to give a written informed consent.
2.Subjects of either sex in the age group of 40 to 60 years.
3.Patients with a diagnosis of knee Osteoarthritis as per American College of Rheumatology clinical and radiographic criteria.
4.Knee Osteoarthritis confirmed by radiological changes as per Kellgren & Lawrence radiological scale of at least grade 2 in X-ray.
5.Osteoarthritis Patients with mean baseline pain intensity of 4 in Visual Analogue Scale (VAS) of 10 in one or both knees.

Exclusion Criteria

1.The subjects who are known to have congenital dysplasia, gouty arthritis, rheumatoid arthritis, psoriatic arthritis and other autoimmune diseases, malignancies, history of any trauma or fractured joint or surgical history to the joint.
2.Patients with gross disability in performing daily normal routine i.e., bedridden subjects or confined to a wheelchair, having any deformity of knee, hip or back altering the gait and posture.
3.Patient who has been administered any chondroprotective drugs, intra-articular injection into the affected knee joint or invasive measures have been performed at the affected joint or systemic medication with corticosteroids during the preceding 3 months.
4.Patients on medication likely to influence evaluation.
5.Pregnant or lactating women 6.Patients with an acute mental disorder, a serious acute organic disease, or any serious comorbidity that made it impossible to participate in the trial interventions.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WOMAC questionnaire for pain and physical function	0- day, 15th day, 30th day

Secondary Outcome Measures

Name	Time	Method
1. Visual analogue scale (VAS) score for pain and stiffness.	3. 30 (thirty) second chair stand test

Trial Locations

Locations (1): Mahatma Gandhi Ayurved College, Hospital and Research Centre
🇮🇳
Wardha, MAHARASHTRA, India
Mahatma Gandhi Ayurved College, Hospital and Research Centre
🇮🇳Wardha, MAHARASHTRA, India
Dr Shweta Parwe Prof Head Dept of Panchakarma MGACHRC Wardha
Principal investigator
9511659185
drshwetaparve@gmail.com