Cancer-related insomnia
Conditions
Interventions
Experimental group:Jiawei Guizhui Longgu Oyster decoction (processed granules) plus original sleeping pills (such as estazolam tablets oral treatment, 1 mg/ time) before going to bed, once a night. Th
Control group:Comfort granules in addition to sleep AIDS (such as Esazolam tablets for oral treatment, 1 mg/ time) should be taken once a night before bed. Placebo (made of stevioside, dextrin, etc.)
Sponsors
Yueyang Hospital Of Inthgrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1 Patients diagnosed as malignant tumors by pathology; 2 With typical insomnia symptoms, in line with the diagnostic criteria of western medicine, PSQI score greater than 7; 3 Age =18 years old and =80 years old, stable vital signs, expected survival time more than 6 months, and clear consciousness; 4 Patients without major organ dysfunction, NRS score 0-3; 5 Patients who had taken sedative and sedative drugs (benzodiazepines, non-benzodiazepines, antidepressants, hormone replacement drugs) for more than or equal to one month before enrollment; 6 Understand and agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1 Patients with serious diseases of the heart, liver, kidney and hematopoietic system, pregnancy or lactation, or with a history of uncontrollable mental illness; 2 patients with intracranial tumors and cognitive impairment; 3 known to be allergic to TCM ingredients; 4 are participating or have participated in other drug clinical trials within 4 weeks; 5. Patients with sleep disorders before malignant tumors; 6. Drug abuse and drug dependence; 7. Patients with severe psychological trauma recently, such as the death of relatives and friends, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI Scale); | — |
Secondary
| Measure | Time frame |
|---|---|
| thyrotropin releasing hormone;corticotropin releasing hormone;Dopamine;Cortisol;Melatonin;5-hydroxytryptamine;EORTC QLQ-C30;Hamilton anxiety scale;Insomnia Severity Index;The Epworth Sleeping Scale; | — |
Countries
China
Contacts
Public ContactYang Shi
Yueyang Hospital Of Inthgrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed