Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04482829
Status:
UNKNOWN
Last Update Posted:
2020-07-23
First Post:
2020-07-03
Brief Title:
TCM in the Treatment of Lung Adenocarcinoma
Sponsor:
Henan University of Traditional Chinese Medicine
Organization:
Henan University of Traditional Chinese Medicine
Study Overview
Official Title:
Efficacy and Safety of Jing-yuan-kang Granule in the Treatment of Lung Adenocarcinoma
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to evaluate the efficacy and safety of Jin-yuan-kang granule in the treatment of lung adenocarcinoma LUAD preliminarily and provide reference for further study
Detailed Description:
Lung adenocarcinoma LUAD is a type of non-small cell lung cancer NSCLC with a rapid disease progression and poor treatment effect The LUAD patients have a short median survival time with 8-11 months Up to now chemotherapy is still the first-line treatment for LUAD PC protocol pemetrexed cisplatin is most commonly used which is also recommended by NCCN guidelines However critical side effects have limited the application and efficacy Patients will undergo poor quality of life and the disease will progress rapidly We still face the stern situation for the treatment of LUAD It is urgent to develop new treatment and management strategies Our previous study showed that jing-yuan-kang granule has certain curative effect on LUAD
This is a multi-certers randomized controlled clinical trial to assess the efficacy and safety of Jing-yuan-kang granule in improving quality of life for LUAD patients After a 2-week wash-out period a total of 144 LUAD patients will be randomly assigned into experimental or control group with a ratio of 11 On the basis of that all the participants will receive PC chemotherapy and symptomatic treatment the patients in the experimental group will receive jing-yuan-kang granule with no other treatments for control group The primary outcome is quality of life The secondary outcomes include Karnofsky KPS scores clinical symptoms and change of tumor volume Safety and adverse events will also be assessed
This is a multi-certers randomized controlled clinical trial to assess the efficacy and safety of Jing-yuan-kang granule in improving quality of life for LUAD patients After a 2-week wash-out period a total of 144 LUAD patients will be randomly assigned into experimental or control group with a ratio of 11 On the basis of that all the participants will receive PC chemotherapy and symptomatic treatment the patients in the experimental group will receive jing-yuan-kang granule with no other treatments for control group The primary outcome is quality of life The secondary outcomes include Karnofsky KPS scores clinical symptoms and change of tumor volume Safety and adverse events will also be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None