Insomnia. Insomnia
Conditions
Interventions
Intervention 1: Intervention group: Fourth 690 mg capsules of Monavvem capsule, two capsules at evening and two capsules at night (one hours before usual sleep time). Intervention 2: Control group:
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Inclusion Criteria:Individuals aged 18 to 65 with the diagnosis of insomnia; ISI Score>7; no history of severe drug reaction to certain types of herbal medicines found in the drug; without using allopathic sleep aid medication in a week ago; Patients with the oral or written informed consent
Exclusion criteria
Exclusion criteria: Exclusion critria: Patients with uncontrolled and severe organic or psychiatric diseases as Parkinson's disease, Alzheimer's; alchohol or substance abuse; any other medication use or their withdrawal which affects sleep; history of blood coagulation disorders as thrombosis or emboli; other sleep disorders; pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity Insomnia. Timepoint: Baseline, 4th week, 8th week. Method of measurement: severity index Insomnia (ISI).;Sleep Quality. Timepoint: Baseline, 4th week, 8th week. Method of measurement: Sleep Quality Assessment (PSQI).;Anxiety. Timepoint: Baseline, 4th week, 8th week. Method of measurement: Hamilton's Anxiety Rating Scale (HAM-A).;Depression. Timepoint: Baseline, 4th week, 8th week. Method of measurement: Hamilton's Depression Scale (HAM-D). | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: The end of study. Method of measurement: Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZohreh Poursaleh
Shahid Beheshti University of Medical Sciences
Outcome results
None listed