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临床试验/CTRI/2018/10/016156
CTRI/2018/10/016156已完成3 期

Efficacy of Individualized Homoeopathic Medicines in Treatment of Cervical Spondylosis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

National Institute of Homoeopathy1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年1月11日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
140
试验地点
1
主要终点
0-10 Numeric Rating Scales measuring intensity of pain, stiffness, numbness, tingling, weakness and vertigo

研究概览

简要总结

Cervical spondylosis (CS) is a degenerative condition of the cervical spine, with approximately 80-90% people suffering from disc degeneration by the age of 50 years. This trial attempts at evaluating efficacy of individualized homeopathic medicines (IHMs) against placebos in treatment of CS. A 3-months, double-blind, randomized, placebo-controlled trial was conducted at the Organon of Medicine outpatient department of National Institute of Homoeopathy, India. Patients were randomized to receive either IHMs (n=70) or identical-looking placebos (n=70) in the mutual context of concomitant conservative and standard physiotherapeutic care. Primary outcomes measures were 0-10 Numeric Rating Scales (NRSs) for pain, stiffness, numbness, tingling, weakness and vertigo, and secondary outcome was Neck Disability Index (NDI); measured at baseline and every month, until 3 months. Intention-to-treat sample was analyzed to detect group differences and effect sizes. Overall improvements were higher in the IHMs group than placebo, but group differences were statistically non-significant with small effect sizes(all P>0.05, two-ways repeated measure analysis of variance). After 2 months of timepoints, improvements observed in the IHMs group were significantly higher than placebo on few occasions (e.g., pain NRS: P<0.001; stiffness NRS: P=0.024; weakness NRS: P=0.003). Sulphur (n=21; 15%) was the most frequently prescribed medicine. No harms, unintended effects or any serious adverse events were reported from either group. An encouraging, but a non-significant direction of effect was elicited favoring IHMs against placebos in treatment of CS.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant, Investigator and Outcome Assessor 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

  • Diagnosed cases of cervical spondylosis (ICD M47.8) 2) Age 18 to 65 years 3) Both sexes 4) Literate patients; able to read English and/or Bengali 5) Patients giving written consent to participate.

排除标准

  • Patients having severe degenerative changes (e.g. disc prolapse, myelopathy, radiculopathy etc) as suggested by radiological findings 2) Patients undergoing homoeopathic treatment for any chronic disease within last 3 months 3) Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness affecting quality of life or any organ failure 4) Pregnancy and lactation 5) Substance abuse and/or dependence 6) Self-reported immune-compromised state.

结局指标

主要结局

0-10 Numeric Rating Scales measuring intensity of pain, stiffness, numbness, tingling, weakness and vertigo

时间窗: At baseline, every month up to month 3

次要结局

  • Neck Disability Index (NDI) measuring quality of life related to cervical spondylosis(At baseline, every month up to month 3)

研究者

申办方类型
Government medical college

研究点 (1)

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