Ciwujia Capsules/Compound Ciwujia Granules in the Treatment of Insomnia

Hui Zhu

Status: Not yet enrolling

Conditions: Insomnia Disorders

Treatments: Drug: Ciwujia Capsules/Compound Ciwujia Granules

Study type: Observational

Funder types: Other

Identifiers

NCT07286838

HBZY2024-C62-02

Details and patient eligibility

About

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?

Full 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?

Enrollment: 40,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40,000 participants in 1 patient group

insomnia patients

Treatment:

Drug: Ciwujia Capsules/Compound Ciwujia Granules