CTRI/2011/12/002197
Completed
Phase 4
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 sites92 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Primary Insomnia
- Sponsor
- Institute of PostGraduate Medical Education and Research
- Enrollment
- 92
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Perceived total sleep time of \< 6 hours per night
- •2\.Insomnia severity index \> 7
- •3\.Willing to provide written informed consent
Exclusion Criteria
- •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- •10\.Patients who were using any other medication that are known to influence sleep but which could not be withdrawn.
Outcomes
Primary Outcomes
Not specified
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