Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms

NCT05764798 | Unknown Phase 1 DMC

• 1 other identifier: NFEC-2023-030
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, placebo-controlled, double-blind clinical study. 60 cases of insomnia patients with depressive symptoms are planned to be treated, and they are randomly assigned to the experimental group (Shugan Jieyu Capsule combined with zolpidem group) and the control group (placebo combined with zolpidem group) in equal proportion. Both groups are given zolpidem orally for basic treatment, with the treatment dose of 10mg per tablet per day, one tablet per time, once a day, before sleep, for 8 consecutive weeks. The test group was given Shugan Jieyu Capsule orally, with a therapeutic dose of 0.36g per capsule, 2 capsules each time, twice a day, and once after breakfast and dinner. The control group was given placebo orally, with a treatment dose of 0.36g per capsule, 2 capsules each time, twice a day, and once after breakfast and dinner. The therapeutic effect of Shugan Jieyu Capsule on insomnia patients with depressive symptoms was observed by analyzing the changes of ISI scores, subjective and objective sleep indicators (PSG, sleep diary), daytime cognitive function, autonomic nervous function and EEG after the intervention in the fourth and eighth weeks.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Insomnia severity index scale

  Changes in insomnia severity index scale

  Baseline and four, eight weeks after treatment

Secondary Outcomes (15)

• Pittsburgh sleep quality index scale

  Baseline and four, eight weeks after treatment

• Patient health questionnaire

  Baseline and four, eight weeks after treatment

• Facade severity scale

  Baseline and four, eight weeks after treatment

• Epworth sleeping scale

  Baseline and four, eight weeks after treatment

• Polysomnography

  Baseline and four, eight weeks after treatment

Study Arms (2)

Experimental group: Shugan Jieyu Capsule combined with zolpidem

EXPERIMENTAL

Zolpidem was given orally for basic treatment, with the treatment dose of 10mg/tablet per day, one tablet per time, once a day, before sleep, for 8 consecutive weeks. Shugan Jieyu Capsule was given orally, with a therapeutic dose of 0.36g/capsule, 2 capsules each time, twice a day, and once after breakfast and dinner.

Drug: Experimental group: Shugan Jieyu Capsule combined with zolpidem

Control group: Placebo combined with zolpidem

PLACEBO COMPARATOR

Zolpidem was given orally for basic treatment, with the treatment dose of 10mg/tablet per day, one tablet per time, once a day, before sleep, for 8 consecutive weeks. Placebo was given orally, with a therapeutic dose of 0.36g/capsule, 2 capsules each time, twice a day, and once after breakfast and dinner.

Drug: Control group: Placebo combined with zolpidem

Interventions

Experimental group: Shugan Jieyu Capsule combined with zolpidem DRUG

Shugan Jieyu capsule and zolpidem orally for 8 consecutive weeks

Experimental group: Shugan Jieyu Capsule combined with zolpidem

Control group: Placebo combined with zolpidem DRUG

Placebo and zolpidem orally for 8 consecutive weeks

Control group: Placebo combined with zolpidem

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Conform to DSM-5 diagnostic criteria for insomnia.
• Moderate or above depressive symptoms: patient health questionnaire depression scale (PHQ-9) ≥ 10 points.
• No drug treatment for insomnia and/or depression within one month before the start of this study.
• female or male.
• Can understand and comply with the research protocol, and can sign a written informed consent.

You may not qualify if:

• Shift workers, perennial night shift workers, frequent cross time zone pilots (such as crew members of international flights).
• PSG examination revealed sleep apnea syndrome (Apnea Hypopnea Index, AHI) ≥ 15 times one hour) and/or periodic limb movement disorder (periodic Limb Movement Index, PLMI\] ≥ 15 times one hour).
• Those who have serious heart disease (such as heart failure, acute myocardial infarction, arrhythmia, coronary heart disease), liver disease (such as hepatitis, cirrhosis, liver cancer, alcoholic liver), lung disease (such as asthma, acute pneumonia, tuberculosis, lung cancer), kidney disease (such as acute and chronic glomerulonephritis, nephrotic syndrome) and other systemic diseases (such as diabetes) that need treatment.
• Have previously diagnosed mental disorders.
• Comply with DSM-5 diagnostic criteria for depression
• Allergic constitution, known or suspected of hypericum perforatum, acanthopanax senticosus and zolpidem allergy history.
• The past used of zolpidem or Shugan Jieyu capsule was ineffective.
• Liver function test ALT, AST\>2 times the upper limit of reference value, or Scr\>the upper limit of reference value.
• The P450 3A4 inhibitors of liver metabolic cytochrome enzyme have been used within 14 days before randomization, including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, acezotocin, indinavir, nafinavir, linavir, fluvoxamine, and saquinavir.
• The P450 3A4 inducer of liver metabolic cytochrome enzyme has been used within 14 days before randomization, including but not limited to phenytoin, carbamazepine, barbiturates, rifampicin, St. John's wort, and glucocorticoids.
• The abuse of opioids, amphetamines, barbiturates, cocaine, cannabis or hallucinogens according to DSM-IV standards 4 weeks before enrollment.
• Medical conditions that affect the absorption, distribution, metabolism or excretion of the study drug.
• Participated in clinical research of other drugs 4 weeks before enrollment or longer before enrollment according to actual requirements.
• Pregnant or lactating women.
• Those who committed serious suicide or committed suicide planning.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related Publications (1)

• Xin Q, Paudel D, Zhang J, Wei H, Cheng Y, Xu Y, Fang R, Jiang J, Wang Y, Zhang B. Efficacy and safety of Shugan Jieyu capsules in combination with zolpidem for insomnia disorder with depressive symptoms: a double-blind randomized controlled trial. BMC Complement Med Ther. 2025 Oct 17;25(1):383. doi: 10.1186/s12906-025-05142-z.

  PMID: 41107798 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bin Zhang, MD & PhD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Zhang, MD & PhD

CONTACT

86-20-62786731; zhang73bin@hotmail.com

Meilei Su, MD

CONTACT

86-20-62786731; sumeilei@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 13, 2023
• Study Start: November 30, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 13, 2023

Record last verified: 2022-11

Locations

CN (1)