Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms
NCT05764798, Phase 1, Unknown, Nanfang Hospital, Southern Medical University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms | ClinicalTrials.gov |
| NCT number | NCT05764798 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Nanfang Hospital, Southern Medical University | ClinicalTrials.gov |
| Conditions | Insomnia | ClinicalTrials.gov |
| Interventions | Experimental group: Shugan Jieyu Capsule combined with zolpidem, Control group: Placebo combined with zolpidem | ClinicalTrials.gov |
| First posted | 2023-03-13 | ClinicalTrials.gov |
| Last updated | 2023-03-13 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Insomnia severity index scale | Baseline and four, eight weeks after treatment | Changes in insomnia severity index scale | ClinicalTrials.gov |
| Secondary | Pittsburgh sleep quality index scale | Baseline and four, eight weeks after treatment | Changes in pittsburgh sleep quality index scale | ClinicalTrials.gov |
| Secondary | Patient health questionnaire | Baseline and four, eight weeks after treatment | Changes in patient health questionnaire | ClinicalTrials.gov |
| Secondary | Facade severity scale | Baseline and four, eight weeks after treatment | Changes in facade severity scale | ClinicalTrials.gov |
| Secondary | Epworth sleeping scale | Baseline and four, eight weeks after treatment | Changes in epworth sleeping scale | ClinicalTrials.gov |
| Secondary | Polysomnography | Baseline and four, eight weeks after treatment | Changes in the time to fall asleep, times of waking up at midnight and times of waking up early | ClinicalTrials.gov |
| Secondary | Sleep diary | Baseline and four, eight weeks after treatment | Changes in the time to fall asleep, the total time to wake up in the middle of the night and the time to wake up early | ClinicalTrials.gov |
| Secondary | Generalized anxiety disorder scale | Baseline and four, eight weeks after treatment | Changes in generalized anxiety disorder scale | ClinicalTrials.gov |
| Secondary | Beck scale for suicide ideation--Chinese Version scale | Baseline and four, eight weeks after treatment | Changes in beck scale for suicide ideation--Chinese Version scale | ClinicalTrials.gov |
| Secondary | Concise happiness and quality of life satisfaction questionnaire | Baseline and four, eight weeks after treatment | Changes in concise happiness and quality of life satisfaction questionnaire | ClinicalTrials.gov |
| Secondary | Event-related potential | Baseline and four, eight weeks after treatment | Changes in P300 latency | ClinicalTrials.gov |
| Secondary | Heart rate variability analysis | Baseline and four, eight weeks after treatment | Changes in low frequency, high frequency, very low frequency, low frequency/high frequency | ClinicalTrials.gov |
| Secondary | N-back paradigm task | Baseline and four, eight weeks after treatment | Changes in reaction time and accuracy | ClinicalTrials.gov |
| Secondary | Suicide stroop task | Baseline and four, eight weeks after treatment | Changes in reaction time and accuracy | ClinicalTrials.gov |
| Secondary | Go/no-go association task | Baseline and four, eight weeks after treatment | Changes in reaction time and accuracy | ClinicalTrials.gov |
| Secondary | Psychomotor vigilance task | Baseline and four, eight weeks after treatment | Changes in reaction time | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Go/No-Go Association Task | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Psychomotor Vigilance Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)