Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms

NCT ID: NCT05764798

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2024-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group: Shugan Jieyu Capsule combined with zolpidem

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.

Group Type: EXPERIMENTAL

Experimental group: Shugan Jieyu Capsule combined with zolpidem

Intervention Type: DRUG

Shugan Jieyu capsule and zolpidem orally for 8 consecutive weeks

Control group: Placebo combined with zolpidem

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.

Group Type: PLACEBO_COMPARATOR

Control group: Placebo combined with zolpidem

Intervention Type: DRUG

Placebo and zolpidem orally for 8 consecutive weeks

Interventions

Experimental group: Shugan Jieyu Capsule combined with zolpidem

Shugan Jieyu capsule and zolpidem orally for 8 consecutive weeks

Intervention Type: DRUG

Control group: Placebo combined with zolpidem

Placebo and zolpidem orally for 8 consecutive weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• 18-60 female or male.
• Can understand and comply with the research protocol, and can sign a written informed consent.

Exclusion Criteria

• 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.
• Substance or alcohol dependence (except complete remission and caffeine or nicotine dependence) according to DSM-IV standard at the time of inclusion.
• 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.
• Other situations unsuitable for inclusion in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bin Zhang, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bin Zhang, MD & PhD

Role: CONTACT

zhang73bin@hotmail.com

86-20-62786731

Meilei Su, MD

Role: CONTACT

sumeilei@126.com

86-20-62786731

Facility Contacts

Bin Zhang, MD＆PHD

Role: primary

zhang73bin@hotmail.com

References

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.

Reference Type: DERIVED

PMID: 41107798 (View on PubMed)

Other Identifiers

NFEC-2023-030

Identifier Type: -

Identifier Source: org_study_id