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Construction and implementation of a comprehensive tumor prevention and treatment system based on traditional Chinese medicine principles: a randomized double-blind placebo-controlled clinical trial evaluating the efficacy of Xihuang Jiedu capsule in preventing postoperative recurrence and metastasis of lung cancer.

A randomized double-blind placebo-controlled clinical trial evaluating the efficacy of Xihuang Jiedu capsule in preventing postoperative recurrence and metastasis of lung cancer.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001428
Enrollment
Unknown
Registered
2025-07-16
Start date
2024-11-14
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Non-small cell lung cancer

Interventions

control group:Xihuang Jiedu capsule placebo
experimental group:Xihuang Jiedu capsule

Sponsors

Guang'anmen Hospital Chinese Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with stage II-IIIA non-small cell lung cancer (NSCLC) after surgery confirmed by pathology or cytology. 2. Disease-free patients after adjuvant postoperative treatment. Enroll within 52 days after the last chemotherapy drug administration; or for those who have completed neoadjuvant chemotherapy before surgery enroll within 1 month after the end of surgical treatment. 3. Have completed at least 4 cycles of the adjuvant chemotherapy regimen specified in the NCCN guidelines. 4. Age between 18 and 75 years old. 5. Performance status score (ECOG): 0 - 1 point. 6. Expected survival period = 6 months. 7. The subjects have no severe dysfunction of major organs such as the liver kidneys and heart.

Exclusion criteria

Exclusion criteria: 1. Patients receiving targeted therapy; 2. Patients with adenocarcinoma and confirmed Ex19del/L858R (+); 3. Patients currently participating in other clinical trials; 4. Patients who have a fertility plan within one year are pregnant or are breastfeeding; 5. Patients who cannot cooperate with follow-up; 6. Patients allergic to the study drug; 7. Any situation that may prevent the subject from completing the follow-up process including but not limited to severe and difficult-to-control organic diseases or infections unstable angina pectoris congestive heart failure etc.; patients with severe liver and kidney function abnormalities; patients with symptomatic and difficult-to-control neurological or mental diseases or mental disorders; patients with uncontrolled central nervous system metastases obvious intracranial hypertension or neuropsychiatric symptoms.

Design outcomes

Primary

MeasureTime frame
disease-free survival;

Secondary

MeasureTime frame
2-year disease-free survival rate;1-year disease-free survival rate;clinical symptom;quality of life;overall survival;

Countries

China

Contacts

Public ContactHou Wei

Guang'anmen Hospital Chinese Academy of Traditional Chinese Medicine

houwei1964@163.com010-88001192

Outcome results

None listed

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