A Randomized, Parallel-Controlled Clinical Study on the Treatment of Yin-Deficiency Type Cancer-Related Insomnia with Modified Baihe Dihuang Decoction Combined with Press Needle

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2026
INTERVENTION: Traditional Chinese Medicine (TCM) Group:Taking sedative‐hypnotic medication combined with the Modified Baihe Dihuang Decoction;Traditional Chinese Medicine Combined with Press Needle Group:Taking sedative‐hypnotic medication combined with the Modified Baihe Dihuang Decoction and press needles;Control Group:The control group will continue the original anti‐tumor treatment regimen and maintain the treatment (supportive and symptomatic treatment) as well as the sedative‐hypnotic medications that were being taken before enrollment.; CONDITION: Cancer‐Related Insomnia PRIMARY OUTCOME: Pittsburgh sleep quality index; SECONDARY OUTCOME: EuroQol Five‐Dimensional Five‐Level;Hamilton Anxiety Scale;Hamilton Depression Scale;Insomnia Severity Index;Sleep apnea monitoring data / Data from sleep respiratory monitoring; INCLUSION CRITERIA: 1. Age = 18 years and = 80 years; male or female. 2. Patients with a pathologically confirmed diagnosis of a malignant tumor. 3. Meet the diagnostic criteria for insomnia (or "bu mei" in TCM) according to both Western medicine and Traditional Chinese Medicine, and meet the diagnostic criteria for Yin‐deficiency syndrome. 4. A cumulative score > 7 on the Pittsburgh Sleep Quality Inde X(PSQI). 5. Have been taking sedative‐hypnotic medications (including benzodiazepines, non‐benzodiazepines, antidepressants, or hormone replacement therapy) for at least one month prior to enrollment.
Epistemonikos ID: 9b5c8bbee091c76bb8727f32ab5f4b6e4a027b6b
First added on: May 09, 2026