Clinical trial · Interventional
Yangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients
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
NCT04641819CI-TRIAL-00077623unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Sleep Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Treatment | Other | — | UNRESOLVED |
| Yangzheng Compound Mixture | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Yangzheng Compound Mixture plus conventional treatment
- description
- 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.
- interventionNames
- Drug: Yangzheng Compound Mixture
- Other: Conventional Treatment
- type
- OTHER
- label
- conventional treatment only
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.