CTRI/2019/01/017332招募中4 期
An open label single arm non-comparativeStudy to assess effectiveness and safety ofZolpidem Tartrate in patients of insomniaWith Diabetes Mellitus
Dr Faraz Farishta0 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
- 4 期
- 状态
- 招募中
- 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
- •1. Healthy adult patients (both male and female) who are 18 to < 65 years of age.
- •2. Must experience sleep disturbances (difficulty in sleep initiation or middle of the night awakening or early morning awakening or poor quality of sleep) for at least 3 nights/week, based on historical data.
- •3. Insomnia Severity Index score of >= 8 at screening.
- •4. Patients with a clinical diagnosis of Diabetes Mellitus on treatment with anti diabetic agents. (At least one year prior to screening).
- •5. Patient willing to sign informed consent form.
排除标准
- •1. Currently using prescription and non-prescription sedative drugs given for more than 2 days for the purpose of sleep disturbances or to relieve jet lag with the last 28 days proceeding to enrolment.
- •2. Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days.
- •3. Evidence of any medical condition as revealed by history, physical examination or laboratory assessment which may interfere with administration or assessment of study medication.
- •4. History of current Hypertension.
- •5. Current alcohol or drug abuse.
- •6. Patients viewed by the investigator as not being able to complete the study.
- •7. History of obstructive sleep apnoea or restless leg syndrome
- •8. History of myasthenia gravis
- •9. History of hepatic insufficiency
- •10. History of respiratory depression
- •11. Patients with a known history of hypersensitivity to Zolpidem tartrate or any of the inactive ingredients
- •12. The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebro vascular disease or malignancy.
- •13. Patients with history of severe cardiac, hepatic, neurological and renal diseases within 6 months prior of screening.
- •14. Pregnant or breastfeeding.
- •15. Patient having participated in a clinical trial in the month before.
- •16. Patients with history of bipolar disorder, psychosis, major depression, unstable anxiety disorders/panic attacks.
- •17. Patients with cognitive impairment
- •18. Elderly patients having symptoms of urinary obstructions
- •19. Patients with symptoms of chronic/ incapacitating pain
- •20. Patients with diabetic neuropathy
- •21. Patients with any other serious disease or condition at screening that might affect the
- •normal sleep pattern.
- •22. Known history of other sleep disorders (i.e. narcolepsy; hypersomnia; parasomnias
- •such as sleep walking, night terrors, recurring nightmares; circadian rhythm sleep
- •23. Patients who are taking other CNS depressants drugs like antipsychotics
- •(neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines or CYP 3A4 or CYP 1A2 inducers or inhibitors.
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