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Clinical study of Modified Soft Liver and Antidepressant Decoction in patients with compensated stage of cirrhosis with insomnia(Type of liver depression and spleen deficiency)

Clinical study of Modified Soft Liver and Antidepressant Decoction in patients with compensated stage of cirrhosis with insomnia(Type of liver depression and spleen deficiency)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600131438
Enrollment
Unknown
Registered
2026-09-02
Start date
2022-08-09
Completion date
Unknown
Last updated
2026-09-07

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

Conditions

insonmia

Interventions

Treatment group:Modified Soft Liver and Antidepressant Decoction combined with basic symptomatic treatment
Control group:basic symptomatic treatment

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Western medicine is consistent with the diagnosis of compensatory stage (stage 1 and 2) and insomnia of liver cirrhosis, Chinese medicine distinguishes the classification of liver depression and spleen deficiency; 2) insomnia secondary to cirrhosis; 3) Between 18~70 years old, gender is not limited, nationality is not limited; 4) Those who have not undergone psychotherapy, physical therapy and drug treatment for insomnia in the past 1 month; 5) Voluntarily participate in this research, have good understanding and communication skills, fully understand and sign the informed consent form after education.

Exclusion criteria

Exclusion criteria: 1) Patients with decompensated cirrhosis, accompanied by serous cavity effusion, gastrointestinal bleeding, hepatic encephalopathy, severe bacterial infection, chronic renal failure, malignant tumor and other related complications; 2) Patients with severe electrolyte disorder, i.e., blood potassium < 3.0 mmol/L and sodium < 120 mmol/L; 3) Patients with serious primary diseases of cardiovascular and cerebrovascular system, hematopoietic system, kidney system and history of mental disorders; 4) Allergic constitution or known ingredients of related drugs included in this study; 5) The woman is in the prepregnancy, pregnancy or lactation period.

Design outcomes

Primary

MeasureTime frame
Sleep Quality Score;TCM syndrome score;—

Secondary

MeasureTime frame
liver function;liver fibrosis;LSM;AST to Platelet Ratio Index(APRI);Fibrosis-4(FIB-4);—

Countries

China

Contacts

Public ContactHu Weiye, Xiao Shuyun

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine

lindaxsy@163.com+86 189 3051 6989

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026