CTRI/2020/03/023789已完成4 期
Prescriber Based, Active Post Marketing Surveillance Study (PMS) to Generate TheSafety & Efficacy Data Of Diazepam and Propranolol in The Treatment of Chronic Anxiety & Insomniain Actual Field Conditions Of Use.
AN Pharmacia Laboratories Pvt ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Both Male and Female patient.
- •2. Ages: > 18 years and < 65 years.
- •3. Patients with Chronic Anxiety and Insomnia.
- •4. Confirmed diagnosis of primary insomnia (as defined by
- •the Diagnostic and Statistical Manual for Mental
- •Disorders-IV [DSM-IV-TR]) present at the time of
- •evaluation for at least 3 months
- •5. Baseline Hamilton Rating Scale for Anxiety (HAMA)
- •scores >=18
- •6. Patient with history of primary insomnia
- •7. Women of child bearing age willing to take contraceptive
- •measure to prevent pregnancy during the study
- •8. Patients willing to give written informed consent
排除标准
- •1. History of hypersensitivity to the study drugs
- •2. Chronic heart failure, respiratory failure or chronic liver and renal failure.
- •3. Patient with active cancer
- •4. Female who is pregnant, planning a pregnancy (during the course of the study) or nursing a child
- •5. Certain medications that may interfere with the study medication and worsen the patient condition (these will be identified by the study Investigator).
- •6. Patients with a history of chronic hepatitis B or C infection, HIV infection.
- •7. Clinically significant disorder that may unsuitable for study participation.
研究者
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