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A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714608
Recruitment Status : Unknown
Verified March 2016 by Tasly Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
First Posted : March 21, 2016
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Tasly Pharmaceuticals, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Drug: Ginsenoside H dripping pills Drug: Ginsenoside H dripping pills+Placebo Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PhaseⅡa, Placebo Parallel Control, Central Randomized, Double Blind, Dosage Exploring and Multi-Center Study to Evaluate the Efficacy and Safety of Ginsenoside H Dripping Pills in Patients With Advanced NSCLC (Syndrome Of Qi-Deficiency)
Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ginsenoside H dripping pills
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.
Drug: Ginsenoside H dripping pills
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: Ginsenoside H dripping pills+Placebo
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.
Drug: 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 Comparator: Placebo
Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.
Drug: Placebo
Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: through study completion, an average of 1 year ]
    Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: through study completion, an average of 1 year ]
    Evaluate overall survival (OS) in the 3 groups

  2. Time to progression(TTP) [ Time Frame: through study completion, an average of 1 year ]
    Evaluate time to progression(TTP) in the 3 groups

  3. Quality of Life [ Time Frame: through study completion, an average of 1 year ]
    [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.

  4. Symptoms scores of TCM [ Time Frame: through study completion, an average of 1 year ]
    0 , every 4 weeks and the end of treatment

  5. Cancer-related fatigue [ Time Frame: through study completion, an average of 1 year ]
    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


Other Outcome Measures:
  1. Blood routine test [ Time Frame: through study completion, an average of 1 year ]
    0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment

  2. Urine routine test [ Time Frame: through study completion, an average of 1 year ]
    0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment

  3. Hepatic function [ Time Frame: through study completion, an average of 1 year ]
    0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically or cytologically proven stage IIIB/IV NSCLC with a measurable lesions (including postoperative recurrence or metastasis)
  2. The patients who can not be treated by surgical resection, conventional radiotherapy and chemotherapy or molecular targeted drugs treatment failure, not willing to accept, or intolerance to radiotherapy and chemotherapy or molecular targeted therapy.
  3. The TCM Syndrome diagnosis of Qi-Deficiency.
  4. Aged 18-75 years, both male and female.
  5. ECOG performance status 0-2.
  6. Expected to survive more than 3 months.
  7. Joined in the test voluntarily and signed the Informed consent by GCP regulation.

Exclusion Criteria:

  1. Liver and kidney damage(TBIL、ALT、AST is higher than the limit of normal value of 1.5 times, abnormal Cr).
  2. Patients with significant cachexia.
  3. Untreated symptomatic brain metastases.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714608


Contacts
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Contact: Min Zhao, PhD 008613820845180 zhaomin@tasly.com
Contact: Ning Dai 008613612187689 daining@tasly.com

Locations
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China, Guangdong
Guangdong Provincial Hospital of TCM Not yet recruiting
Guang Zhou, Guangdong, China, 510120
Contact: Wanyin Wu         
The First Affiliated Hospital of Guangzhou University of TCM Recruiting
Guang Zhou, Guangdong, China, 510405
Contact: Lizhu Lin         
China, Jiangsu
Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine Recruiting
Nan Jing, Jiangsu, China, 210028
Contact: Shibing Liao         
China, Shanghai
Jing'an District Centre Hospital of Shanghai Not yet recruiting
Shang Hai, Shanghai, China, 200040
Contact: Xueyong Wu         
Shuguang Hospital Affiliated with Shanghai University of TCM Recruiting
Shang Hai, Shanghai, China, 201203
Contact: Qi Li         
China, Sichuan
West China Hospital ,Sichuan University Recruiting
Cheng Du, Sichuan, China, 610041
Contact: Ying Zhang         
The Second People's Hospital of Yibin Not yet recruiting
Yibin, Sichuan, China, 644000
Contact: Yuming Jia         
China, Tianjin
Tianjin People's Hospital Recruiting
Tian Jin, Tianjin, China, 300000
Contact: Qiang Yao         
China, Zhejiang
Hangzhou First People's Hospital Not yet recruiting
Hang Zhou, Zhejiang, China, 310002
Contact: Shengyou Lin         
Sponsors and Collaborators
Tasly Pharmaceuticals, Inc.
Investigators
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Study Director: Min Zhao, PhD Tasly Group, Co. Ltd.
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Responsible Party: Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02714608    
Other Study ID Numbers: TCM0319
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms