The effect of Monavvem capsule on chronic insomnia
Phase 3
Recruiting
- Conditions
- Insomnia.Insomnia
- Registration Number
- IRCT20190217042737N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 52
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 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Side effects. Timepoint: The end of study. Method of measurement: Questionnaire.