Yangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients
Carcinoma, Sleep Disorder
About this trial
This is an interventional treatment trial for Carcinoma focused on measuring Yangzheng Compound Mixture, Carcinoma, Sleep Disorder
Eligibility Criteria
Inclusion Criteria:
- Age ≥18;
- Histologically or cytologically confirmed as malignant tumor;
- Receiving chemotherapy or a combination of chemotherapy;
- The syndrome differentiation of traditional Chinese medicine is the Qi-yin deficiency syndrome;
- Sleep disorders were diagnosed by investigators and the Pittsburgh Sleep Quality Index (PSQI) score was ≥ 8;
- The date of diagnosis of sleep disorder is later than the date of the first diagnosis of cancer. Or patients with sleep disorders for a long time receiving regular treatment,sleep disorders aggravated after cancer diagnosis or chemotherapy;
- Pain has been controlled well [patients were being treated with analgesics regularly,numerical rating scale(NRS) score ≤ 3];
- The participant must be able to read and express themselves clearly, can communicate with investigators and cooperate in completing the questionnaire;
- Participants voluntarily join the study with good compliance, and are willing to sign a written informed consent document;
- Survival period will be longer than 6 months.
Exclusion Criteria:
- Pregnant or lactating women;
- Allergic to Yangzheng Compound Mixture;
- Previous diagnosis of sleep apnea;
- The laboratory test value of liver and renal function is more than 2.5 times the upper limit of normal value;
- Symptoms of brain metastasis due to malignant tumor has not been effectively controlled;
- Participating in other drug clinical trials which did not allow to participate in this study;
- Refused to cooperate with follow-up;
- The researchers did not consider it appropriate for the patients to participate in this study for other reasons.
Sites / Locations
- Chongqing University Cancer HospitalRecruiting
- First Affiliated Hospital, Heilongjiang University of Chinese MedicineRecruiting
- Jiamusi Cancer HospitalRecruiting
- Henan Cancer HospitalRecruiting
- The Second Affiliated Hospital of Hunan University of Chinese MedicineRecruiting
- The Third Affiliated Hospital of Shandong First Medical UniversityRecruiting
- Shuguang Hospital Affiliated with Shanghai University of TCM
- Zhongshan HospitalRecruiting
- Affiliated Hospital of Shanxi University of Chinese MedicineRecruiting
- Cancer Hospital of The University of Chinese Academy of SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Yangzheng Compound Mixture plus conventional treatment
conventional treatment only
Yangzheng Compound Mixture: 10mL, 2 doses each time, 3 times a day, three weeks for a course of treatment. Investigators recommended that the participants of experimental group should use Yangzheng Compound Mixture for 2 courses at least. Conventional treatment: Antitumor therapies: chemotherapy or combined chemotherapy. Sleep disorders: includes but is not limited to pharmacotherapy and exercise therapy. The examination, diagnosis and treatment of other concomitant diseases and tumor complications are based on clinical routine. We will collect information about all the combined medicine.
Antitumor therapies: chemotherapy or combined chemotherapy. Sleep disorders: includes but is not limited to pharmacotherapy and exercise therapy. The examination, diagnosis and treatment of other concomitant diseases and tumor complications are based on clinical routine. We will collect information about all the combined medicine.