This study is a single-center, three-arm, open-label randomized controlled trial designed to compare the effectiveness of integrated care, standard medical care, and Ayurvedic care in adults with early knee osteoarthritis (Kellgren-Lawrence grades I-II). Knee osteoarthritis is a leading cause of pain, functional limitation, and reduced quality of life, and current management often provides incomplete symptom relief. Although conventional medical and Ayurvedic interventions are widely used in clinical practice, comparative evidence evaluating these treatment approaches individually and in combination remains limited. A total of 300 participants aged 30-65 years with primary knee osteoarthritis will be randomly allocated in a 1:1:1 ratio to receive standard medical care, Ayurvedic care, or integrated care. The standard medical care group will receive oral paracetamol, topical diclofenac spray, transcutaneous electrical nerve stimulation (TENS), and superficial heat or cold therapy. The Ayurvedic care group will receive Trayodashang Guggulu, Ashwagandha Churna, Janubasti therapy, and topical application of Mahanarayana Taila. The integrated care group will receive Trayodashang Guggulu, Ashwagandha Churna, topical diclofenac spray, and portable transcutaneous electrical nerve stimulation (TENS). Participants will be followed for 24 weeks. Primary outcome measures include changes in knee pain intensity, knee osteoarthritis symptoms, knee joint surface temperature, and gait kinematic parameters. Secondary outcome measures include changes in erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). The findings of this study are expected to provide evidence regarding the comparative effectiveness of integrated care, standard medical care, and Ayurvedic care in the management of early knee osteoarthritis.
Knee osteoarthritis (KOA) is one of the most prevalent chronic musculoskeletal disorders and a leading cause of pain, disability, reduced mobility, and impaired quality of life worldwide. Conventional medical management primarily focuses on reducing pain and improving function through pharmacological and non-pharmacological interventions, whereas Ayurvedic management utilizes a holistic approach incorporating herbal medications and external therapeutic procedures. Although both treatment approaches are widely practiced, comparative evidence evaluating conventional medical care, Ayurvedic care, and an integrated treatment approach remains limited. This study aims to compare the effectiveness of these three treatment strategies in individuals with early knee osteoarthritis. This study is a single-center, three-arm, open-label randomized controlled trial in which 300 participants aged 30-65 years with primary knee osteoarthritis (Kellgren-Lawrence grades I-II) will be randomly allocated in a 1:1:1 ratio to receive standard medical care, Ayurvedic care, or integrated care. Participants will be followed for 24 weeks after randomization. Baseline assessments will include demographic characteristics, clinical examination, radiographic evaluation, and laboratory investigations. Participants allocated to the Standard Medical Care group will receive oral paracetamol, topical diclofenac spray, transcutaneous electrical nerve stimulation (TENS), and superficial heat or cold therapy. Participants allocated to the Ayurvedic Care group will receive Trayodashang Guggulu, Ashwagandha Churna, Janubasti therapy, and topical application of Mahanarayana Taila. Participants allocated to the Integrated Care group will receive Trayodashang Guggulu, Ashwagandha Churna, topical diclofenac spray, and portable transcutaneous electrical nerve stimulation (TENS). The primary objective of the study is to compare the effectiveness of the three treatment approaches in reducing knee pain, improving knee osteoarthritis symptoms, reducing joint inflammation, and improving gait. Primary outcome measures include changes in knee pain intensity assessed using the Visual Analogue Scale (VAS), knee osteoarthritis symptoms assessed using the CRD Pune version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), knee joint surface temperature assessed using infrared thermography, and gait kinematic parameters assessed using three-dimensional gait analysis. Outcome assessments will be performed at baseline and during follow-up according to the study schedule. Secondary outcome measures include changes in erythrocyte sedimentation rate (ESR) and serum C-reactive protein (CRP) to evaluate systemic inflammation associated with the three treatment approaches. The findings of this study are expected to provide evidence regarding the comparative effectiveness of integrated care, standard medical care, and Ayurvedic care in improving pain, physical function, joint inflammation, gait, and quality of life among individuals with early knee osteoarthritis. The results may contribute to the development of evidence-based integrative treatment strategies for the management of early knee osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Trayodashang Guggulu is an Ayurvedic polyherbal formulation administered orally as tablets at a dose of 1 g twice daily with lukewarm water for 24 weeks for the management of knee osteoarthritis.
Ashwagandha Churna is an Ayurvedic herbal powder derived from the root of Withania somnifera and administered orally at a dose of 3 g twice daily with lukewarm water for 24 weeks.
Janubasti is an Ayurvedic external therapeutic procedure in which warm Mahanarayana Taila is retained over the affected knee within a dough ring for 30-35 minutes. A total of 21 sessions will be administered, with 7 sessions during Weeks 1-2, 7 sessions during Weeks 9-10, and 7 sessions during Weeks 17-18.
Mahanarayana Taila is an Ayurvedic medicated oil applied topically over both knees at a dose of 10 mL per knee (20 mL per application) twice daily for 24 weeks.
Topical diclofenac spray is a non-steroidal anti-inflammatory drug (NSAID) formulation applied locally over the affected knee as required for symptomatic pain relief during the 24-week intervention period.
Portable transcutaneous electrical nerve stimulation (TENS) is a non-invasive electrotherapy device that delivers low-voltage electrical stimulation through surface electrodes placed around the affected knee for pain management during the 24-week intervention period.
Paracetamol is a non-opioid analgesic administered orally for symptomatic pain relief during the 24-week intervention period in the Standard Medical Care group and permitted as rescue (SOS) medication for symptomatic pain relief when clinically required in the Ayurvedic Care and Integrated Care groups.
Superficial heat or cold will be applied locally to the affected knee as a non-pharmacological intervention for symptomatic management of knee osteoarthritis during the 24-week intervention period.
All India Institute of Medical Sciences, Jodhpur
Jodhpur, Rajasthan, India
Change in Knee Pain Intensity Assessed by the Visual Analogue Scale (VAS)
Knee pain intensity will be assessed using the Visual Analogue Scale, a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity and represent a worse outcome, whereas lower scores indicate less pain intensity and represent a better outcome. The primary outcome measure is the change in Visual Analogue Scale score from baseline to each scheduled assessment during the 24-week intervention period.
Time frame: Baseline, Weeks: 4, 8, 12, 16, 20 and 24
Change in Physical Function, Pain, and Stiffness Assessed by the CRD Pune Version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Physical function, pain and stiffness will be assessed using the validated CRD Pune Version of the Western Ontario and McMaster Universities Osteoarthritis Index. The scale consists of 24 items, each scored from 0 to 4, with a total score ranging from 0 to 96. The Pain domain ranges from 0 to 20, the Stiffness domain from 0 to 8 and the Physical Function domain from 0 to 68. Higher scores indicate greater pain, stiffness and physical functional difficulty and represent a worse outcome, whereas lower scores indicate less pain, stiffness and physical functional difficulty and represent a better outcome. The primary outcome measure is the change in Western Ontario and McMaster Universities Osteoarthritis Index total and domain scores from baseline to each scheduled assessment during the 24-week intervention period.
Time frame: Baseline, Weeks: 4, 8, 12, 16, 20, and 24
Change in Knee Joint Inflammation Assessed by Infrared Thermography
Knee joint inflammation will be assessed using infrared thermography by measuring changes in skin surface temperature over the affected knee. The primary outcome measure is the change in thermographic findings from baseline to each scheduled assessment during the 24-week intervention period.
Time frame: Baseline, Weeks: 4, 8, 12, 16, 20, and 24
Change in Gait Kinematics Assessed Using G-Walk
Gait kinematics will be assessed using the G-Walk system to evaluate changes in gait patterns and mobility. The outcome measure is the change in gait kinematic parameters from baseline to Week 12 and Week 24.
Time frame: Baseline, Week 12, and Week 24
Change in Erythrocyte Sedimentation Rate (ESR)
Systemic inflammation will be assessed by measuring erythrocyte sedimentation rate (ESR). The outcome measure will be the change in ESR values from baseline.
Time frame: Baseline and Week 24
Change in Serum C-Reactive Protein (CRP)
Systemic inflammation will be assessed by measuring serum C-reactive protein (CRP). The outcome measure will be the change in CRP concentration from baseline.
Time frame: Baseline and Week 24
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