Yangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a nationwide, multicenter, randomized, prospective, real-world study. The purpose of this study is to evaluate the effect and safety of Yangzheng Compound Mixture in the treatment of sleep disorder in cancer patients with Qi-Yin deficiency syndrome during chemotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ShuGuang Hospital
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.; Shaanxi Buchang Pharmaceutical Co., Ltd

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.