Holistic Healing for Knee Osteoarthritis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorAll India Institute of Medical Sciences, Jodhpur

About this trial

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.

Eligibility criteria

Qualifiers

Age between 30 and 65 years, including males and females both

Diagnosis of primary osteoarthritis (OA) affecting at least one knee joint.

Kellgren-Lawrence (KL) grading of 1 or 2, indicating mild to moderate OA severity.

Baseline Numeric Rating Scale (NRS) score of ≥ 5 out of 10, indicating moderate to severe pain intensity.

Disqualifiers

Secondary arthritis due to systemic inflammatory arthritis.

History of post-traumatic knee osteoarthritis.

Previous total knee replacement (TKR) surgery.

Recent corticosteroid use for knee-related conditions.

Trial design

Treatments tested in this trial

  • Trayodashang Guggulu
  • Ashwagandha Churna
  • Janubasti
  • Mahanarayana Taila
  • Topical Diclofenac Spray
  • Portable TENS
  • Paracetamol
  • Superficial Heat or Cold Therapy

Treatment groups

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators

All India Institute of Medical Sciences, Jodhpur

Lead sponsor

Indian Council of Medical Research

Collaborator