Holistic Healing for Knee Osteoarthritis

NCT07768709 | Not Yet Recruiting DMC

• 2 other identifiers: AIIMS/IEC/2025/5532EMDR/CAR/12/2023-00413
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Knee Osteoarthritis (Knee OA)

Keywords

Knee Osteoarthritis; Conventional Standard Care; Janubasti; Gait

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, Week 12, and Week 24

Secondary Outcomes (2)

• Change in Erythrocyte Sedimentation Rate (ESR)

  Baseline and Week 24

• Change in Serum C-Reactive Protein (CRP)

  Baseline and Week 24

Study Arms (3)

Standard Medical Care

ACTIVE COMPARATOR

Participants assigned to this arm will receive standard medical management for knee osteoarthritis for 24 weeks. Treatment includes oral paracetamol, topical diclofenac spray administered as required for pain relief, transcutaneous electrical nerve stimulation (TENS), and superficial heat or cold therapy. Participants will be assessed at baseline and followed at 4, 8, 12, 16, 20, and 24 weeks.

Drug: Topical Diclofenac Spray; Device: Portable TENS; Drug: Paracetamol; Other: Superficial Heat or Cold Therapy

Ayurvedic Care

EXPERIMENTAL

Participants assigned to this arm will receive oral Trayodashang Guggulu (1 g twice daily with lukewarm water), Ashwagandha Churna (3 g twice daily with lukewarm water), Janubasti administered according to the predefined schedule, and topical application of Mahanarayana Taila (10 mL per knee; total 20 mL per application) applied twice daily for 24 weeks. Janubasti will be administered in 21 sessions, with 7 sessions during Weeks 1-2, 7 sessions during Weeks 9-10, and 7 sessions during Weeks 17-18. Participants will undergo scheduled follow-up assessments throughout the study.

Drug: Trayodashang Guggulu; Drug: Ashwagandha Churna; Procedure: Janubasti; Drug: Mahanarayana Taila

Integrated Care

EXPERIMENTAL

Participants assigned to this arm will receive oral Trayodashang Guggulu (1 g twice daily), Ashwagandha Churna (3 g twice daily), topical diclofenac spray as required, and portable transcutaneous electrical nerve stimulation (TENS) for 24 weeks. Participants will undergo scheduled follow-up assessments at Weeks 4, 8, 12, 16, 20, and 24.

Drug: Trayodashang Guggulu; Drug: Ashwagandha Churna; Drug: Topical Diclofenac Spray; Device: Portable TENS; Other: Superficial Heat or Cold Therapy

Interventions

Trayodashang Guggulu DRUG

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.

Ayurvedic Care; Integrated Care

Ashwagandha Churna DRUG

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.

Ayurvedic Care; Integrated Care

Janubasti PROCEDURE

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.

Ayurvedic Care

Mahanarayana Taila DRUG

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.

Ayurvedic Care

Topical Diclofenac Spray DRUG

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.

Integrated Care; Standard Medical Care

Portable TENS DEVICE

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.

Integrated Care; Standard Medical Care

Paracetamol DRUG

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.

Standard Medical Care

Superficial Heat or Cold Therapy OTHER

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.

Integrated Care; Standard Medical Care

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Jodhpur: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

All India Institute of Medical Sciences, Jodhpur

Jodhpur, Rajasthan, 342005, India

Location

Related Publications (10)

• Wu Y, Zhu F, Chen W, Zhang M. Effects of transcutaneous electrical nerve stimulation (TENS) in people with knee osteoarthritis: A systematic review and meta-analysis. Clin Rehabil. 2022 Apr;36(4):472-485. doi: 10.1177/02692155211065636. Epub 2021 Dec 31.

  PMID: 34971318 BACKGROUND

• Hanada M, Takahashi M, Furuhashi H, Koyama H, Matsuyama Y. Elevated erythrocyte sedimentation rate and high-sensitivity C-reactive protein in osteoarthritis of the knee: relationship with clinical findings and radiographic severity. Ann Clin Biochem. 2016 Sep;53(Pt 5):548-53. doi: 10.1177/0004563215610142. Epub 2015 Sep 17.

  PMID: 26384360 BACKGROUND

• Boekesteijn RJ, van Gerven J, Geurts ACH, Smulders K. Objective gait assessment in individuals with knee osteoarthritis using inertial sensors: A systematic review and meta-analysis. Gait Posture. 2022 Oct;98:109-120. doi: 10.1016/j.gaitpost.2022.09.002. Epub 2022 Sep 6.

  PMID: 36099732 BACKGROUND

• De Marziani L, Boffa A, Angelelli L, Andriolo L, Di Martino A, Zaffagnini S, Filardo G. Infrared Thermography in Symptomatic Knee Osteoarthritis: Joint Temperature Differs Based on Patient and Pain Characteristics. J Clin Med. 2023 Mar 16;12(6):2319. doi: 10.3390/jcm12062319.

  PMID: 36983319 BACKGROUND

• Chopra A, Lavin P, Patwardhan B, Chitre D. A 32-week randomized, placebo-controlled clinical evaluation of RA-11, an Ayurvedic drug, on osteoarthritis of the knees. J Clin Rheumatol. 2004 Oct;10(5):236-45. doi: 10.1097/01.rhu.0000138087.47382.6d.

  PMID: 17043520 BACKGROUND

• Modak MD, Barde MP. Efficacy of an Ayurvedic Formulation for Mild-to-moderate Osteoarthritis: A Phase 3, Randomized Controlled Study. Altern Ther Health Med. 2017 Jan;23(1):26-33.

  PMID: 28160761 BACKGROUND

• Kessler CS, Dhiman KS, Kumar A, Ostermann T, Gupta S, Morandi A, Mittwede M, Stapelfeldt E, Spoo M, Icke K, Michalsen A, Witt CM. Effectiveness of an Ayurveda treatment approach in knee osteoarthritis - a randomized controlled trial. Osteoarthritis Cartilage. 2018 May;26(5):620-630. doi: 10.1016/j.joca.2018.01.022. Epub 2018 Feb 7.

  PMID: 29426006 BACKGROUND

• Ariana M, Afrasiabifar A, Najafi Doulatabad S, Mosavi A, Behnammoghadam M. The Effect of Local Heat Therapy versus Cold Rub Gel on Pain and Joint Functions in Patients with Knee Osteoarthritis. Clin Nurs Res. 2022 Jul;31(6):1014-1022. doi: 10.1177/10547738211035502. Epub 2021 Jul 26.

  PMID: 34308678 BACKGROUND

• Yaligod V, Raj DG, Sharma AB, Swami B M, Batra S, Acharya A, Maroo SH, Patel KR, Prajapati V. Dual release paracetamol in osteoarthritis of knee: a randomized controlled clinical trial. J Clin Diagn Res. 2014 Nov;8(11):LC11-5. doi: 10.7860/JCDR/2014/10052.5197. Epub 2014 Nov 20.

  PMID: 25584252 BACKGROUND

• Bookman AA, Williams KS, Shainhouse JZ. Effect of a topical diclofenac solution for relieving symptoms of primary osteoarthritis of the knee: a randomized controlled trial. CMAJ. 2004 Aug 17;171(4):333-8. doi: 10.1503/cmaj.1031793.

  PMID: 15313991 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acetaminophen; Cryotherapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapeutics

Study Officials

• Nitesh M Gonnade, MBBS, MD(PMR)

  All India Institute of Medical Sciences, Jodhpur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitesh M Gonnade, MBBS, MD(PMR)

CONTACT

91 9530199967; drniteshgonnade9@gmail.com

Shobhan B Varthya, MBBS, MD(Pharmacology)

CONTACT

91 8437726777; drshobanpgimer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)