Holistic Healing for Knee Osteoarthritis

Holistic Healing for Knee Osteoarthritis: Comparing Integrated, Standard Medical, and Ayurvedic Care

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07768709
Lead Sponsor: All India Institute of Medical Sciences, JodhpurOTHER_GOV
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 300Estimated
Last Update Posted: Aug 17, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Aug 2028Estimated
Completion Date: Jun 2029Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Holistic Healing for Knee Osteoarthritis: Comparing Integrated, Standard Medical, and Ayurvedic Care
Brief 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

The medical conditions and diseases this study investigates.

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

Interventions

The treatments and procedures being evaluated in this study.

Trayodashang Guggulu
Ashwagandha Churna
Janubasti

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Prior intra-articular viscosupplementation treatment.

Allergy to allopathic and Ayurvedic medications used in the study.

Concomitant skin disease at the application site of any study intervention.

Uncontrolled diabetes mellitus

Chronic Renal failure

Pregnant and lactating females

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Nitesh M Gonnade, MBBS, MD(PMR)Contact

drniteshgonnade9@gmail.com91 9530199967

Locations

Where the study is run and whether each site is currently recruiting.

All India Institute of Medical Sciences, Jodhpur

Jodhpur, Rajasthan 342005, India

Collaborators

The organizations and people involved in this study.

Lead Sponsor: All India Institute of Medical Sciences, JodhpurOTHER_GOV
Collaborators

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Other registered studies that closely resemble this one.

Detailed Description

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.