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Multicenter Open-label Randomized Controlled Trial on treatment and safetyn for reshenguben oral liquid on Cancer-Related Fatigue

Multicenter Open-label Randomized Controlled Trial on treatment and safety for renshenguben oral liquid on Cancer-Related Fatigue

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044250
Enrollment
Unknown
Registered
2021-03-12
Start date
2021-04-30
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

cancer-related fatigue

Interventions

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Male or female between 18 and 80 years old; (2) Tumor patients who have been diagnosed with cancer-related fatigue (the definition of cancer-related fatigue is based on the 2018 NCCN clinical practice guidelines for cancer-related fatigue); (3) Ability to communicate fatigue levels with clinicians and fill out questionnaires independently; (4) The BFI screening assessment score >= 4 points (the sum of the items contained in the total score divided by the total number of items, the score value is between 0-10 points) and at least continued 1 week; (5) ECOG <= 3; (6) Subjects voluntarily joined the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Past use of central nervous system stimulants or antidepressants or history of epilepsy; (2) Those with suspected recurrence or progression of the disease through imaging examinations such as CT or X-ray; (3) Hemoglobin 1.79 ng/dL, thyroid-stimulating hormone > 10 um/dL); (5) Pain cannot be controlled after applying analgesics; (6) During the study period, take veratrum, wulingzhi, acacia or their preparations at the same time; (7) Those who still have insomnia after receiving appropriate treatment; (8) Combined cold; (9) The investigator judges that surgery is needed during the study period; (10) Patients with uncontrollable hypertension (DBP > 100 mmHg or SBP > 160 mmHg); (11) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 3 ULN or active liver disease; blood creatinine> 2 ULN or undergoing renal dialysis treatment; (12) Those who are allergic to the drugs used in this research; (13) Mental and neurological disorders, who cannot express their wishes correctly; (14) Pregnant women, lactating women and women of childbearing age who have not taken contraceptive measures; (15) Patients currently participating in clinical trials of other drugs or medical devices; (16) Those considered by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Compared with baseline, the change in the BFI score at 6 weeks of treatment.;

Countries

China

Contacts

Public ContactLinlin Wang

Shandong Cancer Hospital

wanglinlinatjn@163.com+86 13793187739

Outcome results

None listed

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