insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of Western medical insomnia; 2. Meet the insomnia of deficiency of both heart and spleen of TCM syndrome differentiation standards; 3. Male or female over 18 under 65 years old; 4. Haven't taken Western and/or Oriental medicine and/or dietary supplements in the past one week for insomnia; 5. Signed the written informed consent form for the clinical trial; 6. Reports clinical symptoms for insomnia and score of 7 or above on the PSQI.
Exclusion criteria
Exclusion criteria: 1. Doesn't meet the inclusion criteria; 2. Does not use, cannot judge or judge data is incongruent affect efficacy and safety; 3. Duration of more than 12 years; 4. During pregnancy, women who are breastfeeding or who had a history of drug allergy; 5. Under 18 years of age or over 70 years old; 6. Systemic disease, such as pain, fever, cough, surgery, external environmental disturbances or brain injury; 7. Complicated by cardiovascular, lung, liver, kidney and severe primary disease of the hematopoietic system and organic brain disease; 8. There is serious physical illness, substantial organ damage, nervous system disorders and other mental illnesses; 9. Alcohol and (or) psychoactive substances, drug abusers and drug-dependent persons (including sleeping pills); 10. Fainting and others who cannot tolerate acupuncture treatment, do not fit the operator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep perception;Epworth sleepiness scale;Flinders fatigue scale;Beck's Depression Inventory;The State-Trait Anxiety Inventory; | — |