Holistic Healing for Knee Osteoarthritis

Summary

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.

Conditions

• Primary Knee Osteoarthritis (Kellgren-Lawrence Grade 1-2)

Interventions

DRUG

Trayodashang Guggulu

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.

DRUG

Ashwagandha Churna

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.

PROCEDURE

Janubasti

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.

DRUG

Mahanarayana Taila

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.

DRUG

Topical Diclofenac Spray

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.

DEVICE

Portable TENS

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.

DRUG

Paracetamol

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.

OTHER

Superficial Heat or Cold Therapy

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.

Sponsors & Collaborators

• Indian Council of Medical Research

  collaborator OTHER_GOV

• All India Institute of Medical Sciences, Jodhpur

  lead OTHER_GOV

Principal Investigators

• Nitesh M Gonnade, MBBS, MD(PMR) · All India Institute of Medical Sciences, Jodhpur

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2028-08-31

Completion

2029-06-30

Countries

• India

Study Locations