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Regulating effect of insomnia Granule on circadian disorder sleep disorder

Regulating effect of insomnia Granule on circadian disorder sleep disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013031
Enrollment
Unknown
Registered
2017-10-19
Start date
2017-11-15
Completion date
Unknown
Last updated
2017-10-23

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

Conditions

Circadian disorder of sleep

Interventions

Insomnia granules group:Insomnia granules
placebo group:placebo

Sponsors

Shaanxi Provincial Hospital of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) accord with the diagnosis of circadian rhythm disorder sleep disorders (2) physical examination and related laboratory examinations to eliminate insomnia caused by somatic diseases (3)Excluding other sleep disorders such as periodic limb movement disorder, sleep apnea and low ventilation syndrome,usde by PSG monitorin (4) Pittsburgh sleep quality index score more than 8 points (5) patients volunteered to participate in clinical trials and signed informed consent (6) less than 18 and older than 60 years of age (7) junior high school or above. If none of the above answers is "no", the subjects cannot be included in this study.

Exclusion criteria

Exclusion criteria: (1) patients who are not eligible for inclusion criteria; (2) the Pittsburgh sleep quality index is less than 7; (3) combined with other disorders such as periodic limb movement disorder, sleep apnea hypopnea syndrome and other types of sleep disorders; (4) those with somatic diseases or organic diseases; (5) the use of any sedative or hypnotic drugs in the past week; (6) the use of any antidepressant and antipsychotic drugs in the past two weeks; (7) the use of long-acting antipsychotics in the past month; (8) excluding sleep disorders caused by alcohol or coffee, tea and other life factors; (9) pregnant women and lactating women, women in menstrual period should be evaluated again when they are not menstruating; (10) participants in other clinical trials of drugs in the past month. If any of the above answers is "yes", the subjects cannot participate in this study.

Design outcomes

Primary

MeasureTime frame
SF-36;MEQ-19;ESS;Insomnia Severity Index;PSQI;Hamilton Depression Scale;Hamilton anxiety scale;Insomnia TCM syndrome score;Alertness test;

Countries

China

Contacts

Public ContactCHEN Jun

Shaanxi Provincial Hospital of traditional Chinese Medicine

156919342@qq.com+86 15991658129

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026