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A randomized, double-blind trial of efficacy and mechanism of Shiwei Yiyuan granules for cancer-related fatigue

A randomized, double-blind trial of efficacy and mechanism of Shiwei Yiyuan granules for cancer-related fatigue

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039975
Enrollment
Unknown
Registered
2020-11-15
Start date
2020-11-14
Completion date
Unknown
Last updated
2021-02-22

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

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed primary lung cancer and colorectal cancer patients with measurable lesions can be evaluated for curative effect (Based on RECIST 1.1 therapeutic efficacy evaluation criteria for solid tumors); 2.meet the diagnostic criteria for cancer-related fatigue; 3. Fatigue Score >= 4.(The degree of fatigue was scored using a 0-10 numerical rating scale, 0 = no fatigue, 10 = most severe fatigue); 4. Patients who agree not to participate in other intervention studies during treatment; 5. Aged 18-80 years, regardless of gender; 6. The estimated survival time is greater than 3 months.

Exclusion criteria

Exclusion criteria: 1. The patient who has severe bleeding or is systemically infected; 2. The patient who has a clear invasion of bone marrow metastases; 3. The patient who has received surgery, chemotherapy, radiotherapy, targeted therapy, immune or other anti-tumor therapy within 1 month; 4. The patient who has used of erythropoietin and blood transfusion in the past 1 month; 5. Patient with severe diseases of heart, liver, kidney and other systems; 6. Pregnant women, lactating women, unconscious patients or patient who is unable to understand and participate in this study; 7. As determined by the researcher, patient is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Piper fatigue Survey Scale;

Secondary

MeasureTime frame
karnofsky performance score;Symptom Inventory for TCM;blood routine examination;T lymphocyte and B lymphocyte;

Countries

China

Contacts

Public ContactCui Ning

Xiyuan Hospital of China Academy of Chinese Medical Sciences

809918686@qq.com+86 15652590697

Outcome results

None listed

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