NCT07286838

Ciwujia Capsules/Compound Ciwujia Granules in the Treatment of Insomnia

Effects of Ciwujia Capsules/Compound Ciwujia Granules in the Treatment of Insomnia: a Multicenter, Prospective Real-world Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40,000 (estimated)
• Sponsor: Hui Zhu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Insomnia Disorders

Interventions

Type	Name	Description
DRUG	Ciwujia 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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-03-01
• Completion: 2028-06-01
• First posted: 2025-12-16
• Last updated: 2025-12-16