Health Condition 1: null- Primary Insomnia
Conditions
Interventions
Intervention1: NSF-3
1 tablet to be taken orally daily at bedtime for 2 weeks: 1. Valeriana officinalis (Valerian root) 300 mg
2. Passiflora incarnata (Passion flower) 80 mg
3. Humulus lupulus (Hops)
Sponsors
Institute of PostGraduate Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Perceived total sleep time of 2.Insomnia severity index > 7 3.Willing to provide written informed consent
Exclusion criteria
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abuse. 10.Patients who were using any other medication that are known to influence sleep but which could not be withdrawn. 11.Patients in whom another investigational drug had been used within three months prior to entry in this study. 12.Patients with known allergic reaction to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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total sleep timeTimepoint: baseline, week 1 and week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| average no of night time awakenings per nightTimepoint: baseline, week 1 and week 2;average sleep latency per nightTimepoint: baseline, week 1 and week 2;epworth sleepiness scoreTimepoint: baseline, week 1 and week 2;insomnia severity indexTimepoint: baseline, week 1 and week 2 | — |
Countries
India
Contacts
Public ContactDr Avijit Hazra
Institute of Post graduate Medical Education and Research
Outcome results
None listed