Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency) and explore the optimal dosage
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
Experimental: Ginsenoside H dripping pills. Dosage form:pill. Dosage :20pills ( only ginsenoside H dripping pills). Frequency:two times per day. Duration: until disease progression or death.
Experimental: Drug: Ginsenoside H dripping pills+Placebo. Dosage form:pill. Dosage :20pills ( ginsenoside H dripping pills 10 pills and placebo 10 pills). Frequency:two times per day. Duration: until disease progression or death.
Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.
Guangdong Provincial Hospital of TCM
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival (PFS)
Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment
Time frame: through study completion, an average of 1 year
Overall Survival (OS)
Evaluate overall survival (OS) in the 3 groups
Time frame: through study completion, an average of 1 year
Time to progression(TTP)
Evaluate time to progression(TTP) in the 3 groups
Time frame: through study completion, an average of 1 year
Quality of Life
\[0 , every 4 weeks and the end of treatment\] To determine the quality of life by using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scales.
Time frame: through study completion, an average of 1 year
Symptoms scores of TCM
0 , every 4 weeks and the end of treatment
Time frame: through study completion, an average of 1 year
Cancer-related fatigue
Evaluate the fatigue degree in the 3 groups using the Chinese version of Brief Fatigue Index (BFI-C): 0 , every 4 weeks and the end of treatment
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine
Nanjing, Jiangsu, China
RECRUITINGJing'an District Centre Hospital of Shanghai
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShuguang Hospital Affiliated with Shanghai University of TCM
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospital ,Sichuan University
Chengdu, Sichuan, China
RECRUITINGThe Second People's Hospital of Yibin
Yibin, Sichuan, China
NOT_YET_RECRUITINGTianjin People's Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGHangzhou First People's Hospital
Hangzhou, Zhejiang, China
NOT_YET_RECRUITING