Development and Evaluation of Technical Standards for Diagonosis and Treatment of Integartive Medicine for Insomnia

Phase 1

• Conditions: Insomnia

• Registration Number: ITMCTR2000003977
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index;Pittsburgh sleep quality index;

Secondary Outcome Measures

Name	Time	Method
Cornell Medical Index;