An exploratory randomized controlled pilot trial comparing the effects of individualized homoeopathic medicines in LM and centesimal potencies in managing the pain of knee osteoarthritis in adults
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- To address the feasibility issue of a definitive future trial
研究概览
简要总结
Osteoarthritis is a cause of disability that is rapidly growing among older adults, with its prevalence rising by 137% since 1990 and affecting almost half of people over 80 years of age. Chronic pain, joint stiffness, reduced mobility, and loss of independence are all symptoms of osteoarthritis. Chronic inflammation, cellular senescence, and muscle loss are aging-related mechanisms that accelerate disease progression, while obesity, menopause, and inactivity accelerate joint degeneration. Care remains fragmented and reactive, often relying on surgery, which is not suitable for many due to frailty, despite available treatments like bisphosphonates and emerging therapies like senolytics and regenerative medicine, thus emphasizing the pressing need for a comprehensive, preventative, and person-centered approach that incorporates early screening, personalized non-surgical management, mental health support, physical rehabilitation, and caregiver participation. Homeopathy may have immense potential to offer in successful treatment of pain of Knee Osteoarthritis but the available data shows contradictory results. Under such circumstances, we intend to undertake this research project to evaluate the efficacy of 50 millesimal scale of potencies and to explore the feasibility of a definitive future trial. Many studies were carried out which suggest that LM potencies offer a safe, gentle, and effective approach for managing chronic diseases. An open label, randomized (1:1), centesimal controlled trial will be conducted on 102 adults who are suffering from pain of Knee Osteoarthritis at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Modified Pain Detect Questionnaire(mPDQ) [secondary outcomes], Intermittent and Constant Osteoarthritis Pain(ICOAP)[secondary outcomes] every month up to 3 months. Comparative analysis will be carried out to detect group differences.
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
- 50.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Age 50 to 70 years 2.Participants of either sex or transgender 3.Diagnosed knee oa according to American College of Rheumatology(ACR) clinical or radiographic classification criteria such as knee pain, age more than 50 years, morning stiffness less than 30 minutes, crepitus on active motion, osteophytes on knee xray.
排除标准
- •Not providing with written informed consent of participation.
- •Severe degeneration of knee joint with marked joint narrowing, varus, or valgus deformity of knee, evidenced by imaging or other evidences and requiring surgical intervention, joint or skin infection, joint prostheses of the lower limbs.
- •Non-ambulant patients.
- •Self-reported joint disorders other than osteoarthritis (e.g. inflammatory joint disease, specific arthropathy, hyperuricemia and or gout, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs)
- •Intra articular injections within 2 weeks before study entry
- •Transplanted knees.
- •Recent significant knee surgery within last 6 months
- •Benign tumors and malignant tumors.
- •Patient suffering from active or chronic, systemic or local infection or disease.
- •Patients who are too sick for consultation.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness affecting quality of life.
- •Pregnancy, puerperal women and lactating mother.
- •Tobacco chewing and or smoking, alcoholism and or any form(s) of substance abuse and or dependence.
- •Self reported immune compromised state, AIDS, hepatitis etc.
- •Undergoing homoeopathic treatment for any chronic disease within last 6 months.
结局指标
主要结局
To address the feasibility issue of a definitive future trial
时间窗: 3 months
次要结局
- modified pain detection questionnaire (mPDQ)(At baseline , every month upto 3 months)
- Intermittent and Constant Osteoarthritis Pain(ICOAP)(At baseline , every month upto 3 months)
研究者
Mobasshir Iqbal
D N De Homoeopathic Medical College and Hospital
