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A Multicenter Prospective & Single-Arm Clinical Study of Di'ao Zihuangjing Tablets for Relieving Cancer-Related Fatigue (CRF)

A Multicenter Prospective & Single-Arm Clinical Study of Di'ao Zihuangjing Tablets for Relieving Cancer-Related Fatigue (CRF)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033710
Enrollment
Unknown
Registered
2020-06-10
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

experimental group:Di'ao Zihuangjing Tablets

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with pathologically confirmed malignant tumor (solid tumor, excluding blood malignant tumor); 2. Patients whose clinical stage of tumor is IIIB-IV; 3. Patients who have received at least one cycle of chemotherapy and are expected to receive two or more cycles of chemotherapy of the same regimen in the future; the chemotherapy regimen takes 21 days as one cycle. 4. The score of cancer patients on the subjective fatigue level screening scale is >= 4 points. 5. Patients with normal cognitive function who can independently complete the questionnaire involved in the study; 6. Patients whose hematology, liver and kidney functions and important organ functions meet the requirements of chemotherapy; 7. Patients who have no obvious obstacle in swallowing function and can take the investigational drug smoothly; 8. Patients who know and agree to join the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The patients have other exact causes of fatigue (such as hypothyroidism, insomnia, uncontrolled pain, moderate to severe anemia, severe malnutrition, cachexia, etc.); 2. Patients who have been previously used or are allergic to Zihuangjing; 3. Patients who have been taking prescription stimulants or other drugs / health products clearly marked with anti fatigue effect; 4. Patients with symptomatic intracranial metastasis; 5. Patients with mental disorders (anxiety, manic depression, obsessive-compulsive disorder, schizophrenia), acute or chronic progressive or unstable nervous state (dementia, delirium or epilepsy), cognitive dysfunction; 6. Patients with other diseases requiring glucocorticoid treatment (excluding chemotherapy pretreatment); 7. Patients with poor compliance who are not expected to complete the study as planned; 8. Pregnant or lactating women; 9. Staff of the research center directly related to the test and / or their immediate family members.

Design outcomes

Primary

MeasureTime frame
Piper;

Secondary

MeasureTime frame
CD3;CD4;albumin;Globulin;albumin/Globulin;Hb;EORTC QLQ C30;Adverse events;

Countries

China

Contacts

Public ContactSun Yu

West China Hospital of Sichuan University

55880810@qq.com+86 13408418719

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026