CTRI/2020/03/023823已完成Unknown
Prescriber Based, Active Post Marketing Surveillance Study (PMS) to Generate the Safety & Efficacy Data of Chlordiazepoxide and Trifluoperazine In the Treatment of Chronic Anxiety & Insomnia in Actual Field Conditions of Use
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assessment based on HAMA scale, Clinician Global Impression (CGI) and Patient Global Impression (PGI) scales
研究概览
简要总结
Prescriber Based,Active Post Marketing Surveillance Study (PMS) to Generate the Safety &Efficacy Data of Chlordiazepoxide and Trifluoperazine In the Treatment ofChronic Anxiety & Insomnia in Actual Field Conditions of Useâ€
| Primary Objective: |
The primary objective of this PMS trial is to find out safety & tolerability of the product in patient with Chronic Anxiety and Insomnia†in 200 patients from India.
Secondary Objective:
The secondaryobjective of this PMS trial is to find out efficacy of the product in patientwith by clinician global assessment
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Both Male and Female patients.
- •Ages: > 18 years and < 65 years.
- •Patients with Chronic Anxiety and Insomnia.
- •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.
- •Baseline Hamilton Rating Scale for Anxiety (HAMA) scores≥
- •Patient with history of primary insomnia.
- •Women of child bearing age willing to take contraceptive measure to prevent pregnancy during the study.
- •Patients willing to give written informed consent.
排除标准
- •History of hypersensitivity to the study drugs
- •Chronic heart failure, respiratory failure or chronic liver and renal failure.
- •Patient with active cancer
- •Female who is pregnant, planning a pregnancy (during the course of the study) or nursing a child
- •Certain medications that may interfere with the study medication and worsen the patient condition (these will be identified by the study Investigator).
- •Patients with a history of chronic hepatitis B or C infection, HIV infection.
结局指标
主要结局
Assessment based on HAMA scale, Clinician Global Impression (CGI) and Patient Global Impression (PGI) scales
时间窗: 14 days
次要结局
- Evaluate efficacy of this FDC in treatment of Chronic Anxiety and Insomnia.(14 days)
研究者
研究点 (1)
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