A randomized double-blind placebo-controlled study of Xianghua Compound Granule in the treatment of liver depression type insomnia

Phase 1

Recruiting

• Conditions: iver depression type insomnia

• Registration Number: ITMCTR2000003568
• Lead Sponsor: Shanghai Traditional Chinese Medicine Hospital

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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria for insomnia in ICD-10;
2. The evaluation of TCM syndrome differentiation combined with insomnia TCM syndrome scale accords with liver depression type insomnia;
3. An improved SPIEGEL scale, with a score of >=12 (on a baseline basis, >=12 for insomnia, >=18 for moderate insomnia, and >=24 for severe insomnia).;
4. Outpatient patients aged between 18 and 80 who have informed and agreed to be followed up;
5. Normal only occasionally take sleeping pills, nearly 2 weeks did not take any sleeping and psychotropic drugs;
6. Clear consciousness, stable vital signs, certain expression ability and executive ability, able to cooperate with the completion of tests and treatment.

Exclusion Criteria

1) Those who do not meet the inclusion criteria shall be excluded from severe secondary insomnia;
2) Hamilton Anxiety Scale (HAMA) total score >= 14;
3) Total score of Hamilton Depression Scale (HAMD, 17 items) >= 18;
4) Those who need to take two or more Traditional Chinese and Western medicine with the effect of treating insomnia regularly for a long time;
5) Those who need to take other psychoactive drugs other than the original hypnotic for a long time;
6) Patients with severe cardiovascular, lung, liver, kidney, hematopoietic, endocrine or other diseases, mental disorders, organic brain diseases, substance abuse or obvious visual and hearing impairment;
7) Pregnant or lactating women;
8) Alcoholism or drug dependence;
9) Allergic to the drug used or the ingredients contained in this protocol;
10) Failure to complete other reasons considered by experimenters or researchers.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
SPIEGEL;TCM Syndrome Score Scale;Epworth;PSQI;

Secondary Outcome Measures

Name	Time	Method
Chinese Medicine Syndrome Scale for Insomnia;HAMA;HAMD;