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Suanzaoren Decoction for the treatment of malignant tumor with insomnia (liver-blood deficiency): a randomized, double-blind, placebo-controlled clinical research

Suanzaoren Decoction for the treatment of malignant tumor with insomnia (liver-blood deficiency) a randomized, double-blind, placebo-controlled clinical research

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16008392
Enrollment
Unknown
Registered
2016-04-30
Start date
2016-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Insomnia

Interventions

Treatment group:Take Suanzaoren Decoction granules for 4 weeks
control group:take Placebo for 4 weeks

Sponsors

Changhai Hospital of Traditional Chinese Medicine, Second Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with malignant tumor diagnosed by pathology or cytology(clinical diagnosis was adequate for hepatocellular carcinoma and pancreatic cancer); (2) According with the diagnosis of insomnia; (3)Aware of the purpose of this study, and voluntary cooperation, can truthfully and actively assess their psychological status; (4) No previous history of mental illness; (5) Without taking psychotropic substance abusers in nearly two weeks; (6) Not associated with other medical diseases; (7) KPS score 60 points or more and is expected to survive longer than six months.

Exclusion criteria

Exclusion criteria: (1) Concomitant severe primary heart, brain, liver, kidney and/or hematopoietic system disease, severe complications and comorbidities caused by the cancer, including insomnia caused by cancer pain; (2)Takehypnotic, anxiolytic, antidepressant tablets or other decoction contained semen 2 weeks before join this clinical trials; (3) Pregnancy, breast-feeding women; (4) The certain drug in the prescription allergy; (5) Psychiatry, severe anxiety, depression with SAS, SDS score>=50points; (6) Not medication on time, poor compliance or not adhere to follow-up.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index PSQI;serotonin;norepinephrin;dopamine;melatonin;CD4+,CD8+,CD4+/CD8+;natural killer cell;interleukin- 6;

Secondary

MeasureTime frame
SAS;SDS;

Contacts

Public ContactYang Xue

Changhai Hospital of Traditional Chinese Medicine, Second Military Medical University

yxkxl@163.com+86 13501882159

Outcome results

None listed

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