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临床试验/CTRI/2020/10/028710
CTRI/2020/10/028710招募中2/3 期

Double-blind, randomized, placebo-controlled, pilot evaluation of individualized homoeopathic medicines in insomnia

D N De Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月31日最近更新:

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)

研究者

发起方
D N De Homoeopathic Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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