Insomnia
Conditions
Interventions
Study group 1:take 3mg melatonin capsule and 25 ml oligosaccharide
Study group 2:take 3mg melatonin capsule and 25 ml placebo oral
Study group 3:take 3mg placebo capsule and 25 ml oligosaccharide
Control:take 3mg placebo capsule and 25 ml oligosaccharide
Sponsors
Shanghai Jiao Tong University affiliated Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who met the diagnostic criteria of primary insomnia based on the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) for at least one month; 2. Self-Rating Scale of Sleep >=20 scores; 3. Aged between 40 to 65 years old; 4. Agreed to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. use of hypnotics within the previous 2 weeks r any psychoactive treatment within the previous 3 months; 2. sleep disorders associated with a psychiatric disorder; 3. sleep disorders secondary to another medical condition; 4. use of prohibited concomitant medication or alcoholics; 5. a lifestyle likely to interfere with sleep patterns; 6. Patients with severe organic diseases or with other conditions not suitable for participating in the study at the investigator's discreet; 7. Patients with poor compliance; 8. Pregnant women or women giving breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep latency;total sleep time;morning alert;score of Pittsburgh sleep quality index;Epworth Sleepiness Scale;score of Fatigue Severity Scale;data of polysomnograph; | — |
Secondary
| Measure | Time frame |
|---|---|
| score of WHO-quality of life scale;score of Clinical Global Impression; | — |
Countries
China
Contacts
Public ContactYin Shankai
Shanghai Jiao Tong University affiliated Sixth People's Hospital
Outcome results
None listed