insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) 18-60 years old. 2) Meet the diagnostic criteria of chronic insomnia in Western medicine. 3) Meet the diagnosis of insomnia in Chinese medicine and any one of the insomnia chilling and insomnia heating groups (see Attachment 1). 4) Insomnia Severity Index (ISI) score >7. 5) Signed informed consent. Attachment 1: Diagnostic criteria of Chinese medicine: refer to the diagnostic criteria of insomnia in the standard of Chinese medicine industry of the People's Republic of China "Diagnostic and therapeutic efficacy criteria of Chinese medicine internal medicine illnesses" (ZY/T001.1-94). 1) Diagnostic Criteria for Insomnia in Cold-Chemical Population Primary symptom: fatigue. Secondary symptoms: fear of cold or wind cold limbs palpitation dizziness spontaneous sweating scanty menstruation pale lower eyelids or pale white with red edges. Tongue and pulse: pale tongue weak or fine or dull pulse. The primary symptom must be present two or more of the secondary symptoms are present the tongue and pulse are present but two or more of the following symptoms are not present: obvious dry mouth bitter mouth or halitosis easy to sore throat or easy to mouth ulcers easy to be nervous and anxious hot flashes in the palms of the hands burning and dry stools and redness in the lower eyelids. The diagnosis can be made. 2) Diagnostic Criteria for Insomnia Heating People Primary symptoms: easy sore throat or easy mouth ulcers or acne or fever. Secondary symptoms: hot flashes on the palms of the hands dry mouth bad breath or bitter taste in the mouth easy to be nervous or anxious burning or dry stools burning urine reddish lower eyelids or dark red lips or dry lips pulse rate >5. Tongue and pulse: red tongue scanty or yellowish coating moving or cloudy or stringy or numbered pulse. The primary symptom must be present the secondary symptom has 2 or more the tongue and pulse are present and 2 or more of the following symptoms are not present: pale and insipid mouth easy diarrhea and loose stools after being cold oedema of the lower limbs cold hands and feet on palpation sneezing and sneezing under the carving and the lower eyelids are pale white or pale white with red edges. It can be diagnosed.
Exclusion criteria
Exclusion criteria: 1)Preparing to become pregnant or during pregnancy or breastfeeding or those who need to sleep with their children. 2) Secondary insomnia caused by other illnesses as confirmed by the doctor based on medical history and consultation. For example: localized pain restless leg syndrome sleep apnea syndrome acute and chronic heart failure chronic obstructive pulmonary disease acute and chronic bronchitis etc.; 3) According to the patient's depression self-assessment tool the patient may be suffering from insomnia. (iii) Patients diagnosed as moderately or severely depressed (total score >10) according to the Patient Depression Self-Assessment Tool (PHQ-9). 4) Patients with moderate or severe anxiety (total score >10) according to the Generalized Anxiety Disorder Scale (GAD-7); 5) Patients with a combination of cardiovascular and cerebrovascular disease (GVD); 5) Patients with a combination of cardiovascular and cerebrovascular disease (GVD). 5) Patients with a combination of cardiovascular cerebrovascular pulmonary hepatic renal and endocrine system and other serious diseases; 6) Patients with mental retardation mental retardation and other serious diseases. (6) Persons with mental retardation alcohol or substance abuse or dependence or suicidal tendency. (vii) Those who have participated in clinical trials of other drugs within the past 30 days; (viii) Those with other mental illnesses. (viii) Those who have participated in clinical trials of other drugs within the past 30 days; (ix) Those who have a combination of other mental illnesses (ix) Exclude those who are unable to cooperate for a long period of time; (x) Exclude those who are unable to cooperate for a long time. 10) Patients who are recognized by the physician as requiring disease management based on medical history and consultation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Infrared Thermal Imaging Inspection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulse to Respiration Ratio;Patient Health QuestionnairePHQ-9;Generalized Anxiety Disorder Scale;Pittsburgh Sleep Quality IndexPSQI; | — |
Countries
China
Contacts
No.111 Dade Road Yuexiu District Guangzhou City Guangdong Province China