Skip to content

A randomized placebo-controlled trial for shumian capsule in the treatment of sleep disorders in insomniacs

A randomized placebo-controlled trial for shumian capsule in the treatment of sleep disorders in insomniacs

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024117
Enrollment
Unknown
Registered
2019-06-26
Start date
2019-06-27
Completion date
Unknown
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Sponsors

Department of Psychosomatics and Psychiatry, Zhongda Hospital, School of Medicine, Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) outpatient or inpatient; (2) meet the diagnostic criteria of insomnia disorder for DSM5, with the total score of PSQI >=8 and the Hamilton Depression Rating Scale (HDRS) score <17 and the Hamilton Anxiety Rating Scale (HARS) score <14; (3) Aged 18-60 years old; (4) the patient himself or his legal guardian signs the informed consent.

Exclusion criteria

Exclusion criteria: (1) patients with other mental diseases or secondary insomnia, such as insomnia disorder occurring after the use of certain drugs or on the basis of organic encephalopathy or serious physical diseases; (2) pregnant and nursing women; (3) history of alcohol and drug dependence and serious diseases such as malignant tumors; (4) severe abnormal heart, liver and kidney functions; (5) significant abnormalities in severe laboratory and auxiliary examinations.

Design outcomes

Primary

MeasureTime frame
brain-derived neurotrophic factor ;the monitoring indexes on Polysomnography;

Countries

China

Contacts

Public ContactYuan Yonggui

Department of Psychosomatics and Psychiatry, Zhongda Hospital, School of Medicine, Southeast University

yygylh2000@sina.com+86 13913939082

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026