Efficacy of individualized homoeopathic medicines in Q-potency in treatment of lumbar spondylosis: a double-blind, randomized, placebo-controlled, clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS) for pain.
研究概览
简要总结
Degenerative disease of the lumbar spine is a significantcause of disability in the world; In the 2010 Global Burden of Disease (GBD)Study, It has been found that 266 million individuals (3.63%) worldwide haveDegenerative spine disease and LBP each year; Conventional medical treatmentlike NSAIDS and Epidural steroid injections (ESI) have become a commoninterventional strategy in the management of lumbar spondylosis and thesemedications are having deleterious effects like large intestinal ulcers,bleeding, perforation, non-specific colitis and meningitis, arachnoiditisrespectively. CAM (Complementary/ Alternative medicine) therapy is beingpopular in patients with musculoskeletal disorders including low back pain. Studyin homoeopathy regarding lumbar spondylosis is very scarce.
In order to detect the efficacy of individualizedhomeopathic medicines in Q-potency in treatment of lumbar spondylosis, this double blind, randomized,placebo-controlled, two parallel arms, clinical trial will be conducted on 60patients at The Calcutta Homoeopathic Medical College and Hospital. Patientswill be randomized to receive either individualized homeopathic medicines in Q-potencies, or identical looking placebo.
The outcome measures –visual analog scale(primary), Oswestrydisability index (secondary) will be assessed at baseline, after 3 months,after 6 months of treatment. A specially designed Microsoft Office Excel spreadsheet (master chart) shall be used for data extraction and shall be subjectedto statistical analysis for measuring the group differences. Results will bepublished in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with radiological diagnosis of lumbar spondylosis (2022 ICD-10-CM Diagnosis Code M47.816) Spondylosis w/o myelopathy or radiculopathy, lumbar region
- •Patients who have not taken any treatment since at least 2 weeks for lumbar spondylosis.
- •Literate patients; can read Bengali and/or English
- •Providing written informed consent to participate in the trial.
排除标准
- •Patients suffering from severe degenerative changes as found in radiological findings of lumbar spondylosis.
- •Patients having major life threatening disorder associated with lumbar spondylosis
- •Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life.
- •Patients who are too sick for consultation.
- •Pregnant and puerperal women, and lactating mothers.
- •Substance abuse and/or dependence
- •Self-reported immune-compromised state
- •Undergoing homoeopathic treatment for any chronic disease within last 6 months.
结局指标
主要结局
Visual analog scale (VAS) for pain.
时间窗: At baseline, after 3 months and 6 months
次要结局
- oswestry disability index(At baseline, after 3 months and 6 months)