Evaluating the efficacy of individualized homoeopathic medicines in reducing depression, anxiety, and stress in adults with osteoarthritis of knee: a double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- DASS-21 (Depression, anxiety, and Stress Scale 21) depression subscale
研究概览
简要总结
Depression, anxiety and stress are common psychological comorbidities that impact the quality of life (QoL) of patients with osteoarthritis. it is the most common musculoskeletal disorder worldwide. Osteoarthritis is characterized by degeneration of the articular cartilage, osteophyte formation, and asymmetric joint space narrowing. These changes often lead to significant pain and disability and create a substantial individual, societal, and economic burden. Depression is common in people with OA, with a prevalence of 20% . It is defined as the presence of sad, empty, or irritable mood. Anxiety is defined as the presence of fear or nervousness about what might happen. In the field of Homoeopathy, no researches have been done yet to actively control of these clinical co-morbidities. A deep analysis of individual constitution and miasmatic background with the guidance of therapeutic and reportorial analysis will enrich the homoeopathic literature. A double-blind, randomized (2:1), Placebo Controlled Trial will be conducted on 110 patients who are suffering from depression, anxiety and stress in adults with osteoarthritis of knee at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital. Assessment will be done by DASS-21 (Depression, Anxiety and Stress 21) depression subscale [primary outcome], DASS-21 (Depression, Anxiety and Stress 21) anxiety and stress subscale, KOOS (Knee Injury and Osteoarthritis Outcome score), MYMOP-2 (Measure Yourself Medical Outcome Profile revised version) [secondary outcome], all to be measured every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed knee osteoarthritis (ICD-11 code FAO1) as per American College of Rheumatology (ACR) clinical/radiographic classification criteria45 (sensitivity 91%; specificity 86%).
- •history of trauma over knee, knee pain, stiffness less than 30 min, and crepitus on knee motion, osteophytes on knee x-ray.
- •Age: 50-70 years.
- •Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for depression (five or more symptoms out of nine for 2 weeks including at least one of these: depressed mood and loss of interest or pleasure) and/ or anxiety (more than three symptoms out of six including excessive anxiety and worry occurring at least six months, about number of events or activities) as per American Psychiatric Association (APA)
- •DASS-21 depression score: 10-27 (mild and moderate).
- •Patients of either sex including transgenders.
- •Patients already undergoing regular oral or topical analgesics or NSAID therapy for painful episodes of osteoarthritis, provided the medications are stopped completely at least 2 weeks prior study entry providing written informed consent voluntarily.
排除标准
- •Patients not willing to give written consent voluntarily.
- •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.
- •DASS-21 depression score: 0-9 (normal) and above 28 (extremely severe).
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or lifethreatening illness affecting quality of life
- •Pregnancy, puerperium and lactation.
- •Vulnerable population – Unconscious, non-ambulatory, too ill for consultation, differently abled, terminally ill, or critically ill patients, mentally disabled people.
- •Substance abuse and /or dependence
- •Self-reported immune-compromised state, and
- •Undergoing homoeopathic treatment for any chronic disease within last 6 months
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
DASS-21 (Depression, anxiety, and Stress Scale 21) depression subscale
时间窗: Every month, up to 3 months
次要结局
- DASS-21 (Depression, anxiety, and Stress Scale 21) anxiety and stress subscales(Every month, up to 3 months)
- KOOS (Knee Injury and Osteoarthritis Outcome Score)(Every month, up to 3 months)
- MYMOP-2 (The Measure Yourself Medical Outcome Profile revised version)(Every month, up to 3 months)
研究者
Meghamala Chakraborty
The Calcutta Homoeopathic Medical College and Hospital