Comparison of Lorazepam and Zolpidem effect on insomnia in bone marrow trasplantation patients
Phase 2
- Conditions
- insomnia.Disorders of initiating and maintaining sleep
- Registration Number
- IRCT138811103210N2
- Lead Sponsor
- Vice chancellor for research,Faculty of pharmcy, Shaheed Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Bone marrow transplantation patients that have insomnia base on the
SleepMed Insomnia Index questionnaire; Patients in range of 18-65 years old. Exclusion criteria: Sensitivity to Lorazepam or Zolpidem; Narrow-angle glaucoma; Pregnancy & breast feeding; Hepatic encephalopathy; Rising of hepatic enzymes ( AST, ALT, ALP, LDH ) 3 times the upper limit of normal; Serum creatinine concentration more than 2.5 mg/dl; Use of alcohol; Patients who have no remission in insomnia after taking 4 mg Lorazepam or 10 mg Zolpidem during 4 days; Addiction to opioids
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleepiness. Timepoint: Before intervention and 1, 2, 3 and 4 week after beginning of intervention. Method of measurement: Epworth sleepiness scale questionnaire.;Anxiety and Depression. Timepoint: Before intervention and 4 week after beginning of intervention. Method of measurement: Hospital Anxiety and Depression Scale questionnaire.;Insomnia. Timepoint: Before intervention and 1, 2, 3 and 4 weeks after beginning of intervention. Method of measurement: SleepMed Insomnia Index questionnaire.
- Secondary Outcome Measures
Name Time Method Central Nervous System side effects. Timepoint: 1, 2, 3 and 4 week after beginning of intervention. Method of measurement: Clinical observation.;GastroIntestinal System side effects. Timepoint: 1, 2, 3 and 4 week after beginning of intervention. Method of measurement: Clinical observation.