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

NCT04641819 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1127

Last updated 2024-05-31

No results posted yet for this study

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.

Conditions

  • Carcinoma
  • Sleep Disorder

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.

Sponsors & Collaborators

  • LinkDoc Technology (Beijing) Co. Ltd.

    collaborator INDUSTRY

  • Shaanxi Buchang Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • ShuGuang Hospital

    lead OTHER

Principal Investigators

  • Qi Li, PhD · Shuguang Hospital Affiliated with Shanghai University of TCM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-27
Primary Completion
2023-09-30
Completion
2024-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641819 on ClinicalTrials.gov