Efficacy of Individualized Homoeopathic Medicines in Q-potency in Treatment of Cervical spondylosis: 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
- 140
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
Cervical Spondylosis is a wide spread medical condition that significantly impacts patients quality of life. Cervical spondylosis is a degenerative disease that typically develops as a consequence of ligament and facet joint disorders. Its common symptoms include neck pain, numbness in the root innervation area, nausea, vomiting, vertigo and other related symptoms. In the general population the patients prevalence of neck pain ranges from 0.4 % to 41.5 %, the 1 year incidence ranges from 4.8% to 79.5% and lifetime prevalence may be as high as 86.8%. Age is the most common risk factor for cervical spondylosis. The condition is very common in patients who are middle aged and older. Conservative treatment with analgesics only provides temporary relief. Non-steroidal anti-inflammatory medication used to treat pain and inflammation have limitation since unpleasant side effects occur frequently. Where as in Homoeopathic treatment with individualized medicines, the effectiveness of the treatment with regards to improving the daily life activities in patients suffering from cervical spondylosis is higher. Our aimed to evaluate effects of Homoeopathic medicines beyond placebo by conducting 3- month Double-Blind, Randomized (2:1) , Placebo-controlled Trial of individualized Homoeopathic Medicines i Q potency against placebo at The Calcutta Homoeopathic Medical College and Hospital on 140 participants with Cervical Spondylosis symptoms. For Primary outcome assessment Numerical Rating Scale (NRS) scale is administered and for secondary outcome Neck disability Index Questionairre is taken.
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
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with age group between 18 to 65 years.
- •Patients with clinical findings and radiological findings for cervical spondylosis.
- •Patients of both sexes.
- •Patients willing to give consent to take homoeopathic treatment.
- •Patients with mild to moderate degenerative radiological changes.
- •Patients not having any major disorder associated with cervical spondylosis.
- •Literate patients; able to read English or Bengali, Hindi.
排除标准
- •Patients having major life-threatening disorder associated with cervical spondylosis
- •Pregnant and puerperal women, and lactating mothers.
- •Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life.
- •Other non-specific neck pain lesion, acute neck strain, or whiplash injury.
- •Patient under other medication for the same complaint especially for 6 weeks.
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: At baseline, every 4 weeks, upto three months
次要结局
- Neck Disability Index (NDI) questionnaire(At baseline, every 4 weeks, upto three months)
研究者
SHABNAM REYAZ
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
