Skip to content

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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035673
Enrollment
Unknown
Registered
2020-08-16
Start date
2021-02-22
Completion date
Unknown
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver depression type insomnia

Interventions

Sponsors

Shanghai Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
PSQI;SPIEGEL;Epworth;TCM Syndrome Score Scale;

Secondary

MeasureTime frame
HAMA;HAMD;Chinese Medicine Syndrome Scale for Insomnia;

Countries

China

Contacts

Public ContactXu Jian

Shanghai Traditional Chinese Medicine Hospital

xujian0296@163.com+86 13901781509

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026