Knee Osteoarthritis (Knee OA)HEAL-KOANCT07768709
Holistic Healing for Knee Osteoarthritis
A study testing Trayodashang Guggulu, Ashwagandha Churna and Janubasti in people with Knee Osteoarthritis (Knee OA), run by All India Institute of Medical Sciences, Jodhpur at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Trayodashang Guggulu, Ashwagandha Churna and Janubasti
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Concomitant skin disease at the application site of any study intervention.
- Uncontrolled diabetes mellitus
- Chronic Renal failure
- Pregnant and lactating females
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
All India Institute of Medical Sciences, Jodhpur
Jodhpur, Rajasthan, 342005
Nitesh M Gonnade, MBBS, MD(PMR), 91 9530199967, drniteshgonnade9@gmail.com
Shobhan B Varthya, MBBS, MD(Pharmacology), 91 8437726777, drshobanpgimer@gmail.com
About this study
Official title: Holistic Healing for Knee Osteoarthritis: Comparing Integrated, Standard Medical, and Ayurvedic Care
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.
Read the 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.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Trayodashang Guggulu, Ashwagandha Churna, Janubasti, Mahanarayana Taila, Topical Diclofenac Spray
- Keywords
- Knee Osteoarthritis, Conventional Standard Care, Janubasti, Gait
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trayodashang GugguluDrug
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 ChurnaDrug
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.
JanubastiProcedure or surgery
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 TailaDrug
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 SprayDrug
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 TENSDevice
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.
ParacetamolDrug
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Trayodashang Guggulu; Drug: Ashwagandha Churna; Drug: Topical Diclofenac Spray; Device: Portable TENS; Other: Superficial Heat or Cold Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, and Week 24
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Jodhpur
- Sponsor type
- Other government
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Nitesh Manohar Gonnade, All India Institute of Medical Sciences, Jodhpur
- Investigators
- Nitesh M Gonnade, MBBS, MD(PMR), Principal investigator, All India Institute of Medical Sciences, Jodhpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768709
- Sponsor's protocol ID
- AIIMS/IEC/2025/5532
- Other IDs
- EMDR/CAR/12/2023-00413
- Acronym
- HEAL-KOA
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34971318Hanada 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.
PubMed 26384360Boekesteijn 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.
PubMed 36099732De 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.
PubMed 36983319Chopra 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.
PubMed 17043520Modak 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.
PubMed 28160761Kessler 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.
PubMed 29426006Ariana 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.
PubMed 34308678Yaligod 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.
PubMed 25584252Bookman 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.
PubMed 15313991
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holistic Healing for Knee Osteoarthritis: Comparing Integrated, Standard Medical, and Ayurvedic Care
- ClinicalTrials.gov ID
- NCT07768709
- Acronym / sponsor ID
- HEAL-KOA / AIIMS/IEC/2025/5532
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Knee Osteoarthritis, Conventional Standard Care, Janubasti, Gait
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, JodhpurOther government
- Collaborators
- Indian Council of Medical Research
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Care | Active comparator | Drug: Topical Diclofenac Spray, Device: Portable TENS, Drug: Paracetamol, Other: Superficial Heat or Cold TherapyParticipants 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. |
| Ayurvedic Care | Experimental | Drug: Trayodashang Guggulu, Drug: Ashwagandha Churna, Procedure: Janubasti, Drug: Mahanarayana TailaParticipants 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. |
| Integrated Care | Experimental | Drug: Trayodashang Guggulu, Drug: Ashwagandha Churna, Drug: Topical Diclofenac Spray, Device: Portable TENS, Other: Superficial Heat or Cold TherapyParticipants 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trayodashang GugguluTrayodashang 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 | Ayurvedic Care, Integrated Care |
| Ashwagandha ChurnaAshwagandha 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. | Drug | Ayurvedic Care, Integrated Care |
| JanubastiJanubasti 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. | Procedure or surgery | Ayurvedic Care |
| Mahanarayana TailaMahanarayana 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 | Ayurvedic Care |
| Topical Diclofenac SprayTopical 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. | Drug | Integrated Care, Standard Medical Care |
| Portable TENSPortable 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. | Device | Integrated Care, Standard Medical Care |
| ParacetamolParacetamol 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. | Drug | Standard Medical Care |
| Superficial Heat or Cold TherapySuperficial 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. | Other | Integrated Care, Standard Medical Care |
Primary outcome
Change in Knee Pain Intensity Assessed by the Visual Analogue Scale (VAS)
Time frame: Baseline, Weeks: 4, 8, 12, 16, 20 and 24
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.
Change in Physical Function, Pain, and Stiffness Assessed by the CRD Pune Version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline, Weeks: 4, 8, 12, 16, 20, and 24
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.
Change in Knee Joint Inflammation Assessed by Infrared Thermography
Time frame: Baseline, Weeks: 4, 8, 12, 16, 20, and 24
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.
Change in Gait Kinematics Assessed Using G-Walk
Time frame: Baseline, Week 12, and Week 24
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.
2 secondary outcomes
Change in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and Week 24
Change in Serum C-Reactive Protein (CRP)
Time frame: Baseline and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 34971318Wu 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.
- Background: PubMed 26384360Hanada 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.
- Background: PubMed 36099732Boekesteijn 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.
- Background: PubMed 36983319De 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.
- Background: PubMed 17043520Chopra 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.
- Background: PubMed 28160761Modak 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.
- Background: PubMed 29426006Kessler 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.
- Background: PubMed 34308678Ariana 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.
- Background: PubMed 25584252Yaligod 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.
- Background: PubMed 15313991Bookman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitesh M Gonnade, MBBS, MD(PMR) principal investigator
All India Institute of Medical Sciences, Jodhpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trayodashang Guggulu, Ashwagandha Churna and Janubasti in people with Knee Osteoarthritis (Knee OA), run by All India Institute of Medical Sciences, Jodhpur at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitesh M Gonnade, MBBS, MD(PMR) (91 9530199967, drniteshgonnade9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Pain Intensity Assessed by the Visual Analogue Scale (VAS) (time frame: Baseline, Weeks: 4, 8, 12, 16, 20 and 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07768709, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.