Holistic Healing for Knee Osteoarthritis: Comparing Integrated, Standard Medical, and Ayurvedic Care
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The study is expected to demonstrate that integrated home-based care could be a feasible alternative in terms of pain reduction, functional mobility, and quality of life for early OA knee patients, with improved gait kinematics and positive changes in epigenetic and biochemical markers, compared to standard medical and conventional ayurvedic treatments.
研究概览
简要总结
Rationale: OA causes difficulty in locomotion, and thus, it becomes an issue to attend hospital care; therefore, integrated care is a need. A literature gap exists in comparing standard allopathic care and Ayurvedic intervention for early OA knee, especially regarding clinical insights, gait kinematics, epigenetics, and biochemical markers.
Novelty: To assess the impact of ayurvedic care from a modern science perspective through infrared thermography, epigenetics, biochemical markers, and gait kinematics. Also, we are developing integrated home-based care utilizing the combination of ayurveda and modern medicine to integrate ayurvedic practices into mainstream OA management.
Objectives:
Primary: To assess the impact of integrated care as compared to standard medical care and conventional ayurvedic care on pain, joint inflammation, ADL, quality of life, and gait kinematics
Secondary: To assess the impact of integrated care as compared to standard medical care and conventional ayurvedic care on epigenetic and blood markers.
Methodology: An open-label comparative study comparing three groups; the total sample size is 300 (100 per group) in the 30-65 age group with primary OA knee (Kellgren grading 1 and 2). Ayurveda group receives tailored treatments, including oral medication and Janubasti; the allopathic group follows international guidelines, and the integrated care group will receive ayurvedic oral medicine with topical diclofenac and portable TENS. The outcome variables will include monthly VAS and CRD pune version WOMAC, infrared thermography assessments and gait analysis at baseline, 12 and 24 weeks. Global methylation analysis for epigenetics and biochemical markers (cytokines) will be assessed at baseline and 24 weeks.
Expected Outcome: The study is expected to demonstrate that integrated home-based care could be a feasible alternative in terms of pain reduction, functional mobility, and quality of life for early OA knee patients, with improved gait kinematics and positive changes in epigenetic and biochemical markers, compared to standard medical and conventional ayurvedic treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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 more than or equal to 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.
结局指标
主要结局
The study is expected to demonstrate that integrated home-based care could be a feasible alternative in terms of pain reduction, functional mobility, and quality of life for early OA knee patients, with improved gait kinematics and positive changes in epigenetic and biochemical markers, compared to standard medical and conventional ayurvedic treatments.
时间窗: pain severity assessment ,functional assessment ,joint inflamation will be recorded at baseline,4,8,12,16,20,24 WEEKS, Gait Analysis -baseline,12 & 24 weeks,Biochemical Analysis and Epigenetic analysis -baseline and 24 weeks
次要结局
未报告次要终点
研究者
Nitesh Manohar Gonnade
AIIMS, Jodhpur