chronic insomnia
Conditions
Interventions
TCM group:Qing Gan An Shen granule
Placebo group:placebo granule
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Conforming to the diagnosis criteria for insomnia disorder from the ICSD-3 2. Aged 18–60 years, either male or female. 3. ISI score of 8 to 21. 4.Qi depression constitution based on Traditional Chinese Medicine Constitution criteria. 5. No cognitive impairment or intellectual impairment and ability to complete the questionnaires. 6. Signed informed consent before enrollment.
Exclusion criteria
Exclusion criteria: 1.pregnancy or breast-feeding. 2.any serious concomitant systemic disorder or cancer. 3.Insomnia caused by sleep apnea, restless legs syndrome, pain, etc. 4.HAMA14=14 and HAMD17=17 5.Alcohol or drug addiction. 6.employed in night-shift work or rotational-shift work. 7.currently receiving any other insomnia treatment and cannot stop the treatment. 8.allergic to any ingredients of the QGAS granule or the placebo. 9. currently participating or participated in other clinical trials less than one month prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ISI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index,PSQI;CFS-14;HAMA;HAMD; | — |
Countries
China
Contacts
Public ContactZhou Yang
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Outcome results
None listed