NCT02714608

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2016

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

February 29, 2016

Last Update Submit

March 19, 2017

Conditions

Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Overall Survival (OS)

    through study completion, an average of 1 year

  • Time to progression(TTP)

    through study completion, an average of 1 year

  • Quality of Life

    through study completion, an average of 1 year

  • Symptoms scores of TCM

    through study completion, an average of 1 year

  • Cancer-related fatigue

    through study completion, an average of 1 year

Other Outcomes (3)

  • Blood routine test

    through study completion, an average of 1 year

  • Urine routine test

    through study completion, an average of 1 year

  • Hepatic function

    through study completion, an average of 1 year

Study Arms (3)

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.

Drug: Ginsenoside H dripping pills

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.

Drug: Ginsenoside H dripping pills+Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.

Drug: Placebo

Interventions

Ginsenoside H dripping pillsDRUG

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.

Ginsenoside H dripping pills
Ginsenoside H dripping pills+PlaceboDRUG

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.

Ginsenoside H dripping pills+Placebo
PlaceboDRUG

Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically or cytologically proven stage IIIB/IV NSCLC with a measurable lesions (including postoperative recurrence or metastasis)
  • 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.
  • The TCM Syndrome diagnosis of Qi-Deficiency.
  • Aged 18-75 years, both male and female.
  • ECOG performance status 0-2.
  • Expected to survive more than 3 months.
  • Joined in the test voluntarily and signed the Informed consent by GCP regulation.

You may not qualify if:

  • Liver and kidney damage(TBIL、ALT、AST is higher than the limit of normal value of 1.5 times, abnormal Cr).
  • Patients with significant cachexia.
  • Untreated symptomatic brain metastases.
  • Allergic constitution, or for a variety of drug allergy.
  • Combined with severe cardiovascular, hepatic, renal disease , pregnancy or breast-feeding women, psychopath.
  • \. Participated in other clinical trial within 3 months.
  • \. Treated by chemotherapy, radiotherapy or targeted therapy within 4 weeks.
  • \. Possible to be treated by chemotherapy, radiotherapy or targeted therapy during the study.
  • \. Not fit for the clinical trial judged by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Guangdong Provincial Hospital of TCM

Guangzhou, Guangdong, 510120, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangzhou University of TCM

Guangzhou, Guangdong, 510405, China

RECRUITING

Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine

Nanjing, Jiangsu, 210028, China

RECRUITING

Jing'an District Centre Hospital of Shanghai

Shanghai, Shanghai Municipality, 200040, China

NOT YET RECRUITING

Shuguang Hospital Affiliated with Shanghai University of TCM

Shanghai, Shanghai Municipality, 201203, China

RECRUITING

West China Hospital ,Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The Second People's Hospital of Yibin

Yibin, Sichuan, 644000, China

NOT YET RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310002, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Min Zhao, PhD

    Tasly Group, Co. Ltd.

    STUDY DIRECTOR

Central Study Contacts

Min Zhao, PhD

CONTACT

008613820845180zhaomin@tasly.com

Ning Dai

CONTACT

008613612187689daining@tasly.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 21, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

December 1, 2018

Last Updated

March 21, 2017

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(9)