Ciwujia Capsules/Compound Ciwujia Granules in the Treatment of Insomnia
ConditionInsomnia Disorders
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHui Zhu
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
(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 population
A total of 40000 patients with insomnia were included in this real-world study. Participants were adults aged 18-75 years old who had insomnia disorder, or self-reported history of disturbed sleep.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ciwujia Capsules/Compound Ciwujia Granules
DrugCiwujia Capsule may promote sleep because it has the function of strengthening the spleen, tonifying the kidney, and calming the mind.
Treatment groups
40,000 Participants
are divided into 1 treatment groupGroup A: insomnia patients1 intervention
Trial outcomes
Primary outcomes
1
Pittsburgh Sleep Quality Index (PSQI) score
0-21, and higher scores mean a poorer sleep quality
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
Insomnia Severity Index (ISI) score
0-28, and higher scores mean a worse sleep problem
Time frame
From enrollment to the end of treatment at 8 weeks2
occurrence of adverse events
Time frame
From enrollment to the end of treatment at 8 weeksOther outcomes
1
Sleep diary
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.
Time frame
From enrollment to the end of treatment at 8 weeks2
Sedatives or hypnotics use
If it exists, provide information on the use of sedatives or hypnotics (e.g. drug names, dose, and duration)
Time frame
From enrollment to the end of treatment at 8 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hui Zhu
Lead sponsor
Hubei Hospital of Traditional Chinese Medicine
Sponsor institution
Huazhong University of Science and Technology
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: