ITMCTR2000003977
Not yet recruiting
Phase 1
Development and Evaluation of Technical Standards for Diagonosis and Treatment of Integartive Medicine for Insomnia
Guangdong Provincial Hospital of Chinese Medicine0 sitesTBD
ConditionsInsomnia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults diagnosed with insomnia using the DSM\-5 and ICSD\-3;
- •2\. Aged 18 to 65 years;
- •3\. Pittsburgh Sleep Quality Index (PSQI) \>7 during the screening period and at baseline;
- •4\. Insomnia severity index (ISI)\>7 during the screening period and at baseline;;
- •5\. Stable vital signs with certain expression and cognitive ability;
- •6\. Volunteer to participate in this clinical trial and sign an informed consent form.
Exclusion Criteria
- •1\. Participants with other related medical history that may affect sleep including narcolepsy, circadian rhythm sleep disorder, sleepwalking, sleep\-related breathing disorder, obstructive or central sleep apnea syndrome, restless legs syndrome, etc.;
- •2\. Participants with sever mental illnesses or emotional and behavior disorder disorder (such as schizophrenia, suicidal tendency or suicide history) in the past year, or long\-term use of central nervous system depressant or stimulant drugs;
- •3\. Insomnia caused by other conditions in the past month, such as pain, fever, cough, surgery, interference from the external environment, etc.;
- •4\. Liver function AST and ALT exceed the upper limit of normal reference value by 1\.5 times, or Scr exceeds the upper limit of normal reference value.
- •5\. Participants with severe cardiovascular, lung, liver, kidney, endocrine or central nervous system diseases;
- •6\. Drug and alcohol abuse or dependence;
- •7\. Participants with allergic reaction to the test drug or its ingredients;
- •8\. Pregnant or lactating women, women of childbearing age who cannot take contraceptive measures during the trial;
- •9\. Participants participate in other drug clinical trials within the past month;
- •10\. Researchers consider the participant is inappropriate to participate in this clinical trial.
Outcomes
Primary Outcomes
Not specified
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