An Open-label, Single-arm, Prospective, Multicenter Study to Evaluate Safety and Efficacy of Zolsoma Tablets in Patients with Insomnia - SAEFZ (Safety And Efficacy For Zolsoma)

Pulse Pharmaceuticals Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1.Patients of either gender of age 18 years and above.
•2.Patients visiting Psychiatry opd with complaints of co-morbid disorders.
•3.A history of daytime complaints associated with disturbed sleep.
•4.Patients are required to have language competency to respond to study related questionnaires including Pittsburgh Sleep Quality Index, Insomnia Severity Index and Epworth Sleepiness Scale to measure the quality of sleep and sleep latency.
•5.Patients with self-reported sleep disturbances.
•6.Patients with normal medical history and a record of Physical Examination, Lab Tests are included.
•7.Women of childbearing potential are required to receive a highly effective form of contraception.
•8.Subjects willing to sign the Informed Consent Form.
•9.Subject or legally acceptable representative (LAR) is able to attend all scheduled visits and to comply with the trial protocol.

•1.Patients who have consumed any sedative (Benzodiazepine/ Baribiturate) one week prior to the initiation of the study.
•2.Subjects with history of substance abuse except nicotine use.
•3.Patients with known hypersensitivity or any contraindications to the use of any study medication.
•4.Patients with chronic illness that might interfere with the trial completion or conduct.
•5.Pregnant women & lactating mothers & women intending pregnancy.
•6.Subject who is identified as a natural or adopted child of the investigator, relatives or employee with direct involvement in the proposed study.

发起方