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Zhengyuan Capsule in the treatment of chemotherapy-related cancer-related fatigue in patients with unresectable stage IIIB-IV non-small cell lung cancer--a multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial

Zhengyuan Capsule in the treatment of chemotherapy-related cancer-related fatigue in patients with unresectable stage IIIB-IV non-small cell lung cancer--a multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040061
Enrollment
Unknown
Registered
2020-11-19
Start date
2020-11-23
Completion date
Unknown
Last updated
2021-12-21

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

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically or cytologically diagnosed patients with unresectable stage IIIb-IV non-small cell lung cancer 2. The estimated survival time is more than 3 months, ECOG PS=4.

Exclusion criteria

Exclusion criteria: 1. Any situation that may hinder the subject from completing the clinical trial process, including but not limited to serious, uncontrollable organic disease or infection, unstable angina, congestive heart failure, etc.; 2. Patients with severe liver and kidney dysfunction (serum creatinine >= 1.5 times ULN; ALT or AST >= 3 times ULN; bilirubin >= 1.5 times ULN); patients with symptomatic and difficult-to-control neurological, mental or mental disorders, Those whose thyroid function has not improved; 3. Those who have cognitive impairment and speech expression defects, and are unable to complete the questionnaire independently or with the assistance of others; 4. Patients with concurrent radiotherapy and chemotherapy; 5. Women who are pregnant or breastfeeding or planning to become pregnant; 6. Those with allergies or those who are known to be allergic to the ingredients contained in the test drug; 7. Those who are participating in a clinical trial within three months before the trial; 8. Patients with infectious diseases, such as active hepatitis B, AIDS, syphilis, etc.; 9. Patients with other malignant tumors; 10. Comply with the syndrome differentiation standard of yin deficiency and fire vigor in traditional Chinese medicine; 11. In addition to the above, patients judged by the investigator to be unsuitable to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
BFI scale;

Secondary

MeasureTime frame
Piper scale;Quality of life scale;Clinical symptom score;Exploratory index;Progression-free survival;Safety index;

Countries

China

Contacts

Public ContactLin Lizhu

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

lizhulin26@yahoo.com+86 13501505588

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026