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A multicenter randomized double-blind study on the sensitization of advanced non-small cell lung cancer by Yanghe Tang combined with chemotherapy based on the theory of "Yang deficiency and toxin accumulation": regulation of PARP1/T cell metabolic axis

Yanghe decoction combined with chemotherapy sensitizes advanced non-small cell lung cancer: A multicenter randomized double-blind study on the regulation of PARP1/T cell metabolic axis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001231
Enrollment
Unknown
Registered
2025-06-21
Start date
2018-01-08
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

Advanced non-small cell lung cancer

Interventions

Combined group (Yanghe decoction +TP regimen chemotherapy):Patients in the combination group started taking Yanghe Tang 7 days before chemotherapy and continued until the end of chemotherapy. Yanghe T
Control group (placebo +TP chemotherapy):Paclitaxel 175mg/m2 (or docetaxel 75mg/m2) plus cisplatin 75mg/m2 was given every 3 weeks for 4 cycles. In the course of chemotherapy the dose of chemotherapy

Sponsors

Gansu University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with histologically or cytologically confirmed stage ?B-? NSCLC; Aged between 18-75 years; The expected survival time is more than 3 months; It met the diagnostic criteria of Yang deficiency and toxin knot type in the "Guidelines for the Diagnosis and Treatment of Lung Cancer with Integrated Traditional Chinese and Western Medicine" that is the patient had typical symptoms of Yang deficiency (such as fear of cold and cold limbs waist and knee soreness etc.) and symptoms of toxin knot (such as cough bloody sputum chest pain etc.).

Exclusion criteria

Exclusion criteria: Non-small cell lung cancer patients with unclear TNM staging according to the 8th edition of the Union for International Cancer Control; Patients who survived less than 1 year after diagnosis; Patients with incomplete data; Patients with concomitant tumors of other systems.

Design outcomes

Primary

MeasureTime frame
FPS;ORR;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Integral Evaluation;10/10000 Peripheral blood T cell subpopulations;Cold Fear Score Assessment;PARP1 activity;Serum butyric acid;Mitochondrial ATP;

Countries

CHINA

Contacts

Public ContactZhuZhongbo

Gansu University of Chinese Medicine

451755055@qq.com18093216671

Outcome results

None listed

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