Double-blind, randomized, placebo-controlled, pilot evaluation of individualized homoeopathic medicines in insomnia
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Daily Sleep Diary
研究概览
简要总结
Insomnia can be defined as “chronic inability to fall asleep or remain asleep for an adequate length of time". The worldwide prevalence of insomnia is 10-30%. It is associated with impaired day-time functioning, reduced quality of life (QoL), increased risk of morbidity and substantial societal cost. Many patients perceived homoeopathy to be effective for such problems and several trials suggested that homoeopathy is an effective treatment for insomnia. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 60 patients suffering from insomnia will be randomized to either individualized homoeopathic medicines (verum; n=30) or identical-looking placebo (control; n=30). e aim to investigate whether there are any differences in outcomes between these two groups over 3 months of intervention. Daily sleep diary and insomnia severity index (ISI) scores will be used as the primary an secondary outcome measures respectively. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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 suffering from chronic insomnia (ICD-10-CM G47.0)
- •Patients of either sex
- •Age 18-65 years
- •Literate patients; ability to read Bengali and/or English
- •Patients willing to participate in the study and giving written informed consent.
排除标准
- •Patients who are too unwell to take part
- •Diagnosed cases of unstable psychiatric complaints or other systemic diseases affecting quality of life
- •Currently receiving standard therapy for insomnia and/or homoeopathic treatment for any chronic condition(s)
- •Pregnant, puerperial and lactating women
- •Self-reported immune compromised conditions
- •Substance abuse and/or dependence.
结局指标
主要结局
Daily Sleep Diary
时间窗: At baseline and every month up to 3 months
次要结局
- Insomnia Severity Index (ISI)(At baseline and every month up to 3 months)
