Evaluation of effectiveness and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparision with Zolpidem: A Randomised controlled trial - NITE Study

Institute of PostGraduate Medical Education and Research0 个研究点目标入组 92 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.Women who were pregnant, breast feeding or not willing to use adequate contraception.
•2.Patient with concomitant disorder, psychiatric or otherwise that could potentially disturb sleep.
•3.Patient with history of serious illness of vital organs like liver, kidney, heart, thyroid or bone marrow.
•4.Patients with liver function parameters (total bilirubin, conjugated bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase) more than 2 times upper limit of normal.
•5.Patient habituated to using any sedative hypnotic drugs including benzodiazepines, non-benzodiazepine synthetic drugs, herbal and OTC products.
•6.Patient who were not willing to undergo a run in period of 7 days without sedative-hypnotic drugs.
•7.Patients using tobacco products or caffeinated beverages during night awakenings.
•8.Patients who had undergone long journeys or worked in night shifts within 7 days of presentation or intended to do so during the study period.
•9.Patients with history of alcohol abuse or substance abuse.
•10.Patients who were using any other medication that are known to influence sleep but which could not be withdrawn.
•11.Patients in whom another investigational drug had been used within three months prior to entry in this study.
•12.Patients with known allergic reaction to zolpidem or any of the ingredients of the herbal formulation.
•13.Patients who could not be relied upon to comply with the study procedures.

发起方

Institute of PostGraduate Medical Education and Research