Insomnia Disorders
Conditions
Keywords
Ciwujia Capsules/Compound Ciwujia Granules, Insomnia, real-world study
Brief summary
The goal of this real-world study is to investigate the efficacy and safety of Ciwujia Capsules/Compound Ciwujia Granules in the treatment of insomnia in the clinical real-world. A total of 40000 patients with insomnia are assigned to 8 weeks of Ciwujia Capsules/Compound Ciwujia Granules treatment. The main question it aims to answer is: 1. Is there any significant reduction in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedatives or hypnotics use, and improvement in sleep maintenance after 8 weeks treatment of Ciwujia Capsules/Compound Ciwujia Granules? 2. Is Ciwujia Capsules/Compound Ciwujia Granules a safe method for treating insomnia in adults?
Detailed description
The investigators aimed to investigate the efficacy and safety of Ciwujia Capsules/Compound Ciwujia Granules in the treatment of insomnia in the clinical real-world. Eligible participants were adults aged 18-75 years old who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition \[DSM5\]), or self-reported history of disturbed sleep. The exclusion criteria were (1) self-reported allergy symptoms to any of the ingredients; (2) serious physical sickness; (3) a history of suicidal ideation or attempt, acute or chronic psychiatric condition not controlled by therapy; (4) baseline HAMD-17 score ≥17 or HAMA-14 score ≥14;(5) pregnant women; (6) history of drugs or alcohol abuse/dependence; (7) presence of other sleep disorders including sleep apnoea, restless legs syndrome; (8) participation in concurrent clinical trials.The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) score. The secondary outcomes were the Insomnia Severity Index (ISI) score, sleep diary, sedatives or hypnotics usage, as well as the occurrence of adverse events at 8 weeks. The main question it aims to answer is: 1. Is there any significant reduction in Pittsburgh Sleep Quality Index (PSQI) score, Insomnia Severity Index (ISI) score, subjective sleep latency, sedatives or hypnotics use, and improvement in sleep maintenance after 8 weeks treatment of Ciwujia Capsules/Compound Ciwujia Granules? 2. Is Ciwujia Capsules/Compound Ciwujia Granules a safe method for treating insomnia in adults?
Interventions
DRUGCiwujia Capsules/Compound Ciwujia Granules
Ciwujia Capsule may promote sleep because it has the function of strengthening the spleen, tonifying the kidney, and calming the mind.
Sponsors
Huazhong University of Science and Technology
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hui Zhu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adults aged 18-75 years old who had insomnia disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition \[DSM5\]), or self-reported history of disturbed sleep.
Exclusion criteria
* (1) self-reported allergy symptoms to any of the ingredients; (2) serious physical sickness; (3) a history of suicidal ideation or attempt, acute or chronic psychiatric condition not controlled by therapy; (4) baseline HAMD-17 score ≥17 or HAMA-14 score ≥14;(5) pregnant women; (6) history of drugs or alcohol abuse/dependence; (7) presence of other sleep disorders including sleep apnoea, restless legs syndrome; (8) participation in concurrent clinical trials.The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) score.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) score | From enrollment to the end of treatment at 8 weeks | 0-21, and higher scores mean a poorer sleep quality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) score | From enrollment to the end of treatment at 8 weeks | 0-28, and higher scores mean a worse sleep problem |
| occurrence of adverse events | From enrollment to the end of treatment at 8 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep diary | From enrollment to the end of treatment at 8 weeks | providing daily information on subjective sleep onset latency, subjective total sleep time, subjective sleep quality, subjective wake after sleep onset, and subjective number of awakenings. |
| Sedatives or hypnotics use | From enrollment to the end of treatment at 8 weeks | If it exists, provide information on the use of sedatives or hypnotics (e.g. drug names, dose, and duration) |
Contacts
Primary ContactGang Chen, PhD
Outcome results
None listed