Effectiveness of individualized homoeopathic medicines with centesimal potency in the treatment of bilateral knee osteoarthritis for post menopausal women of age group 45 to 65 years a single arm open label clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- English version of Western ontario mcmaster universities arthritis index (womac)for pain
研究概览
简要总结
Research Question is Does individualized homoeopathic medicines with centesimal potency play any significant role in the treatment of Bilateral knee osteoarthritis for post- menopausal women of age group 45- 65 years ? Null hypothesis is there is no significant changes by individualized homoeopathic medicines with centesimal potency in the treatment of Bilateral knee osteoarthritis for post- menopausal women of age group 45-65 years. Alternative hypothesis is there is significant changes with individualized homoeopathic medicines with centesimal potency in the treatment of Bilateral knee osteoarthritis for post- menopausal women of age group 45- 65 years. Aim is to evaluate the effectiveness of individualized homoeopathic medicines with centesimal potency in the treatment of bilateral knee osteoarthritis for post- menopausal women of age group 45- 65 years focusing on symptoms reduction and quality of life improvements. Primary objective is to determine the changes in the intensity of symptoms in patients with bilateral knee osteoarthritis for post- menopausal women of age group 45- 65 years by using the Western Ontario McMaster Universities Arthritis Index (WOMAC) for pain and stiffness assessment. The secondary objective is to estimate the changes in the quality of life in patients with bilateral knee OA in post- menopausal women of age group 45- 65 years using the EQ-5D-5L questionnaire, a standardized tool for measuring health- related quality of life across five dimensions. It is open- label single arm clinical study, conducted in the OPD of National Institute of Homoeopathy, Kolkata where each case will be taken in detail, appropriate consent taken and then the patient will be enrolled. Appropriate statistical tools will be used and data analysed at the end of the study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients aged 45- 65 years who has already achieved menopause Patients experiencing activity- related knee pain or complaints Patients showing clinical signs and symptoms consistent with knee osteoarthritis or clinically diagnosed knee OA of post- menopausal females Patients with osteoarthritis confirmed through radiological diagnosis Patients who are willing to give consent Patients who can understand either english/ hindi/ bengali language fluently.
排除标准
- •Cases where any kind of surgical intervention of knee has been done before Patients who are already advised to restrict their mobility Female patients with malignant illness or other major conditions(unstable cardiovascular disorders, lung disease, dementia) that limit their ability to adhere to the recommended osteoarthritis treatment Patients with unstable mental health or any kind of psychiatric disorder Patients with any gross pathology or organ failure Patients who excessively use or are dependent on drugs or alcohol Self reported immunocompromised patients Patients who are not willing to give consent.
结局指标
主要结局
English version of Western ontario mcmaster universities arthritis index (womac)for pain
时间窗: Baseline and 6 months
次要结局
- EQ-5D-5L questionnaire for quality of life assessment(Baseline and 6 months)
研究者
Dr Sanyukta Mallick
National Institute of Homoeopathy