Holistic Healing for Knee Osteoarthritis: Comparing Integrated, Standard Medical, and Ayurvedic Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in Knee Joint Inflammation Assessed by Infrared Thermography
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Standard Medical Care
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.
干预措施: Portable TENS (Device)
Standard Medical Care
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.
干预措施: Superficial Heat or Cold Therapy (Other)
Ayurvedic Care
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.
干预措施: Trayodashang Guggulu (Drug)
Ayurvedic Care
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.
干预措施: Ashwagandha Churna (Drug)
Ayurvedic Care
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.
干预措施: Janubasti (Procedure)
Ayurvedic Care
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.
干预措施: Mahanarayana Taila (Drug)
Integrated Care
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.
干预措施: Trayodashang Guggulu (Drug)
Integrated Care
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.
干预措施: Ashwagandha Churna (Drug)
Integrated Care
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.
干预措施: Portable TENS (Device)
Integrated Care
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.
干预措施: Superficial Heat or Cold Therapy (Other)
Standard Medical Care
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.
干预措施: Paracetamol (Drug)
Standard Medical Care
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.
干预措施: Topical Diclofenac Spray (Drug)
Integrated Care
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.
干预措施: Topical Diclofenac Spray (Drug)
结局指标
主要结局
Change in Knee Joint Inflammation Assessed by Infrared Thermography
时间窗: 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
时间窗: 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.
Change in Knee Pain Intensity Assessed by the Visual Analogue Scale (VAS)
时间窗: 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)
时间窗: 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.
次要结局
- Change in Erythrocyte Sedimentation Rate (ESR)(Baseline and Week 24)
- Change in Serum C-Reactive Protein (CRP)(Baseline and Week 24)
研究者
Nitesh Manohar Gonnade
Additional Professor
All India Institute of Medical Sciences, Jodhpur