A prospective study to ascertain the effectiveness of constitutional homoeopathic medicines in cases of osteoarthritis in the age group of 35 to 65 years using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) total score from baseline to follow-up.
研究概览
简要总结
Osteoarthritis (OA) is a common degenerative joint disorder leading to chronic pain, stiffness, and functional disability. Conventional treatments mainly provide symptomatic relief and may have limitations due to side effects or long-term unsustainability. Homoeopathy, as a holistic system of medicine, emphasizes individualized constitutional remedies and has been widely used for musculoskeletal conditions, though systematic evidence remains limited.
This prospective, open-label, single-arm academic study will evaluate the effectiveness of constitutional homoeopathic medicines in patients with mild to moderate osteoarthritis (age 35–65 years), using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale as the primary outcome measure.
A total of 50 patients diagnosed with OA (radiological confirmation, Kellgren-Lawrence criteria) will be enrolled from OPD/IPD and peripheral camps of Sainath Homoeopathic Hospital, Rajkot. Patients will receive individualized constitutional homoeopathic medicines based on detailed case taking. Follow-up will be every 15 days for 12 weeks.
Primary Outcome: Change in WOMAC total score (pain, stiffness, physical function) from baseline to 12 weeks.
Secondary Outcomes: Adverse events, quality of life, patient satisfaction.
This study aims to provide evidence on the role of constitutional homoeopathy in OA management, potentially contributing to integrative approaches for chronic musculoskeletal disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: Patients aged 35-65 years with a diagnosis of osteoarthritis (OA) based on clinical and radiological findings.
- •OA Diagnosis: Patients with a confirmed diagnosis of OA from radiological findings.
- •OA Severity: Patients with mild to moderate OA, as defined by the Kellgren-Lawrence grading system or the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
- •Homoeopathic Treatment: Patients willing to receive homoeopathic treatment as part of the study.
排除标准
- •Severe OA: Patients with severe OA, as defined by the Kellgren-Lawrence grading system or WOMAC.
- •Other Rheumatic Diseases: Patients with other rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, or gout.
- •Recent Injections or Surgery: Patients who have received corticosteroid injections or undergone surgery on the affected joint within the past 6 months.
- •Medications: Patients taking medications that may interfere with the study outcomes, such as:.
- •Corticosteroids , Immunosuppressants , Opioids
- •Pregnancy or Lactation: Pregnant or lactating women.
- •Allergies or Sensitivities: Patients with known allergies or sensitivities to homoeopathic remedies.
- •Concurrent Treatment: Patients receiving concurrent treatment for OA, such as:.
- •Acupuncture.
- •Other alternative therapies
- •Cognitive or Psychiatric Impairment: Patients with significant cognitive or psychiatric impairment that may affect their ability to participate in the study.
结局指标
主要结局
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) total score from baseline to follow-up.
时间窗: Baseline 15 days , 30 days , 45 days post treatment
WOMAC measures pain, stiffness, and physical function — internationally validated, widely used in OA research.
时间窗: Baseline 15 days , 30 days , 45 days post treatment
次要结局
- Change in WOMAC domain scores (pain, stiffness, function) at 4, 8, and 12 weeks.
研究者
Kanani Manas Bhavikkumar
Rajkot Homoeopathic Medical College