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ACTIVE NOT RECRUITING
NCT04641819
PHASE4

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

Sponsor: ShuGuang Hospital

View on ClinicalTrials.gov

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.

Official title: Yangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients With Qi-Yin Deficiency Syndrome During Chemotherapy: a Multicenter, Randomized, Prospective, Real-world Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1127

Start Date

2021-04-27

Completion Date

2024-06-30

Last Updated

2024-05-31

Healthy Volunteers

No

Interventions

DRUG

Yangzheng Compound Mixture

At the end of the treatment period, the investigator can decide whether to continue the medication based on the improvement of the subjects' sleep disturbance. Medication during the follow-up period: subjects will enter the follow-up period after completing one course of Yangzheng Compound Mixture treatment or the end of the treatment period. Visits will be conducted once every 3 weeks, at least 2 times and no more than 4 times. For subjects in the experimental group, doctors can decide whether the patients should continue to receive Yangzheng Compound Mixture therapy in the follow-up period according to the improvement of sleep disorders, while for subjects in the control group, the patients can choose to start receiving Yangzheng Compound Mixture therapy in the follow-up period according to their own wishes and doctors' suggestions.

OTHER

Conventional Treatment

Including treatment of sleep disorders and tumor which shall follow the clinical guidelines.

Locations (10)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

The Third Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Shuguang Hospital Affiliated with Shanghai University of TCM

Shanghai, Shanghai Municipality, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Affiliated Hospital of Shanxi University of Chinese Medicine

Xianyang, Shanxi, China

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, Zhejiang, China