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Single arm clinical trial of Shuhe granules intervention in insomnia with anxiety and depression

Single arm clinical trial of Shuhe granules intervention in insomnia with anxiety and depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000725
Enrollment
Unknown
Registered
2024-11-22
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Insonia Disorder

Interventions

Treatment group:Shuhe Granules: Take orally one bag each time diluted with 150m1 of hot water each time taken orally one hour after meals twice a day.

Sponsors

Runru Mai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 18-65 years old. (2) Meets the diagnostic criteria for chronic insomnia anxiety or depression in Western medicine. (3) ISI (Insomnia Severity Index)>7 points (4) Indications for Shuhe granules (5)10<PHQ-9=19or 5<GAD-7=14 (6) Signatory of informed consent

Exclusion criteria

Exclusion criteria: (1) Based on the medical history and consultation the doctor confirmed that the secondary insomnia was caused by other diseases. For example: local pain restless leg syndrome sleep apnea syndrome acute and chronic heart failure chronic obstructive pulmonary disease acute and chronic bronchitis (2) Patients with severe cardiovascular cerebrovascular liver kidney and endocrine system diseases and unstable conditions (3) Individuals with severe mental and psychological disorders such as bipolar disorder schizophrenia mental retardation alcohol/substance abuse or dependence suicidal tendencies etc (4) Individuals with combined anxiety and depression disorders

Design outcomes

Primary

MeasureTime frame
ISI;

Secondary

MeasureTime frame
GAD-7;Alertness test;PHQ-9;

Countries

China

Contacts

Public ContactRunru Mai

Guangdong Provincial Hospital of Chinese Medicine

mairunru82@163.com13751889226

Outcome results

None listed

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