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Clinical efficacy of spleen spleen in treatment of sleep disorders associated with malignant tumor

Clinical efficacy of spleen spleen in treatment of sleep disorders associated with malignant tumor

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000213
Enrollment
Unknown
Registered
2024-08-11
Start date
2024-02-10
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Malignancy tumor-associated sleep disorders

Interventions

control group :After enrollment, they received 1 month of placebo particles with the same amount and odor appearance, containing 10% treatment group. All granule drugs were provided by Jiangyin Tianji
Treatment group:After enrollment, they were treated with Jianpi Tongluo granules for 1 month: 1) Spleen deficiency syndrome: spleen tongluo granules: 30 g, 15 g, 15 g, 15 g, 15 g, 15 g, 15 g, 15 g, 30

Sponsors

Shanghai Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1)Diagnosis as malignant tumor meets the above diagnostic criteria; 2)Meet the diagnostic criteria for tumor-related sleep disorders; 3) In line with the TCM spleen deficiency syndrome 4) Age is 18 years old, and gender is unlimited; 5)Patients with an estimated survival period of 6 months, physical strength status scoring criteria (ECOG) 2; 6)Consent to receive the follow-up visit; 7)Complete follow-up and clinical relevant medical records; 8)To voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1)Patients with severe heart, brain, liver and kidney diseases, electrolyte abnormalities or mental illness; 2) Allto drugs or ingredients used in the study; 3)Pregnancy, lactation, or planned pregnancy patients; 4) presence of severe or uncontrollable infection; 5)Those who took other Chinese medicine or participated in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The Pittsburgh Sleep Quality Index PSQI scale score;

Secondary

MeasureTime frame
KPS;QLQ-CR38;CEA CA199 CA50 CA125 AFP;Traditional Chinese Medicine Syndrome Points;

Countries

china

Contacts

Public ContactJianlin Ren

Shanghai Traditional Chinese Medicine Hospital

renjianlin666@126.com+86 187 0983 9422

Outcome results

None listed

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