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

A N Pharmacia Laboratories Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Both Male and Female patients. 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.

•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.

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