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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginsenoside H dripping pills | Experimental | Drug: 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. |
|
| Ginsenoside H dripping pills+Placebo | 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 | Placebo Comparator | Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginsenoside H dripping pills | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Evaluate overall survival (OS) in the 3 groups | through study completion, an average of 1 year |
| Time to progression(TTP) | Evaluate time to progression(TTP) in the 3 groups |
| Measure | Description | Time Frame |
|---|---|---|
| Blood routine test | 0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment | through study completion, an average of 1 year |
| Urine routine test | 0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment |
Inclusion Criteria:
Exclusion Criteria:
4 .Allergic constitution, or for a variety of drug allergy.
5 .Combined with severe cardiovascular, hepatic, renal disease , pregnancy or breast-feeding women, psychopath.
6. Participated in other clinical trial within 3 months.
7. Treated by chemotherapy, radiotherapy or targeted therapy within 4 weeks.
8. Possible to be treated by chemotherapy, radiotherapy or targeted therapy during the study.
9. Not fit for the clinical trial judged by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Zhao, PhD | Contact | 008613820845180 | zhaomin@tasly.com | |
| Ning Dai | Contact | 008613612187689 | daining@tasly.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Zhao, PhD | Tasly Group, Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of TCM | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
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| Ginsenoside H dripping pills+Placebo | Drug | 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 | Drug | Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death. |
|
| 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. | through study completion, an average of 1 year |
| Symptoms scores of TCM | 0 , every 4 weeks and the end of treatment | 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 | through study completion, an average of 1 year |
| through study completion, an average of 1 year |
| Hepatic function | 0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment | through study completion, an average of 1 year |
| The First Affiliated Hospital of Guangzhou University of TCM | Recruiting | Guangzhou | Guangdong | 510405 | China |
|
| Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine | Recruiting | Nanjing | Jiangsu | 210028 | China |
|
| Jing'an District Centre Hospital of Shanghai | Not yet recruiting | Shanghai | Shanghai Municipality | 200040 | China |
|
| Shuguang Hospital Affiliated with Shanghai University of TCM | Recruiting | Shanghai | Shanghai Municipality | 201203 | China |
|
| West China Hospital ,Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| The Second People's Hospital of Yibin | Not yet recruiting | Yibin | Sichuan | 644000 | China |
|
| Tianjin People's Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
|
| Hangzhou First People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310002 | China |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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