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临床试验/CTRI/2023/07/055113
CTRI/2023/07/055113尚未招募3 期

To compare the efficacy of combination of Takra Bilva Prayoga and Cognitive Behavioural Therapy with Cognitive Behavioural Therapy alone in improving the quality of sleep in Primary Insomnia- a randomized clinical trial - NI

Vaidyaratnam Ayurveda College0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • DSM â?? V criteria
  • Dissatisfaction with sleep quantity or quality, with one or more of the following symptoms:
  • Difficulty initiating sleep
  • Difficulty maintaining sleep
  • Early morning awakening with inability to return to sleep
  • Sleep disturbances leading to impaired day time functioning evidenced by atleast one
  • of the following : fatigue or low energy
  • Daytime sleepiness
  • Impaired attention, concentration or memory
  • Mood disturbance
  • Behavioural difficulties
  • Impaired occupational or academic function
  • Impaired interpersonal or social function
  • Negative effect on caregiver or family functioning
  • The sleep difficulty occurs at least three nights per week, is present for at least three months,
  • and occurs despite adequate opportunity for sleep.

排除标准

  • Insomnia associated with other sleep disorders (eg- narcolepsy, breathing related sleep
  • disorder, circadian rhythm sleep wake disorder, parasomnia).
  • Insomnia caused by mental disorders and medical conditions.
  • Participants taking allopathic medications for insomnia.
  • Participants with chronic systemic diseases.
  • Participants with uncontrolled hypertension.
  • Pregnant and lactating women.
  • Participants with alcohol dependence and substance abuse
  • Participants who have been part of any other study in the past 6 months.

研究者

发起方
Vaidyaratnam Ayurveda College

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