Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(BCS) With Digestive Tract .
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|ClinicalTrials.gov Identifier: NCT03456609|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinogenic Fatigue||Drug: shenqifuzheng injection Drug: Sodium Chloride Injection 0.9%||Not Applicable|
Factors for the purpose of this study by observing theShenqifuzheng injection before and after treatment in patients with carcinoma due to fatigue scale scores, the classification of syndromes, the quality of life score changes and related laboratory index, evaluation factors ginseng and astragalus injection on the digestive tract tumor (chemotherapy) in patients with cancer-related fatigue and quality of life improved efficacy and safety. The experimental group was randomly divided into 2 groups, experimental group Shenqifuzheng injection of 500 ml. The control group was 0.9% sodium chloride injection, 500ml, intravenous drip, 1 time daily, 14 days for continuous use, 7 days of rest, and 1 treatment for each 21 days, and 2 courses were observed. At the same time, according to the NCCN guide and the health ministry issued the diagnosis and treatment guidelines for cancer treatment.
Main efficacy evaluation indexes before and after treatment for cancer-related fatigue rating - adopting the Piper fatigue scale revised Chinese version, compare the experimental group and the control group before and after treatment cancer-related fatigue rating difference have differences. Secondary efficacy evaluation index to compare the ECOG score difference before and after the treatment, the quality of life score difference before and after the treatment, TCM syndrome curative effect, single symptom curative effect of immune function, tumors had curative effect (if any) and chemotherapy completion. Safety assessment includes the observation of vital signs, blood routine, urinary routine, routine stool, liver function, renal function, electrocardiogram examination, and adverse reactions during the treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy and Safety of Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(Palliative Care) With Digestive Tract Were Prospectively, Randomized Blind, Multicenter Clinical Trials|
|Actual Study Start Date :||January 18, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Drug: shenqifuzheng injection
500ml shenqifuzheng daily（at day 1-14 and day22-36）through intravenous infusion.
|Placebo Comparator: 0.9%sodium chloride||
Drug: Sodium Chloride Injection 0.9%
500ml sodium chloride（0.9%）daily（at day 1-14 and day22-36）through intravenous infusion.
- Piper Fatigue Scale（PFS） [ Time Frame: 42 days ]Change From Baseline in Piper Fatigue Scores at 42 days
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): NCT03456609
|Contact: lin lizhu, Dr.||firstname.lastname@example.org|
|First affiliated hospital of guangzhou university of traditional Chinese medicine||Recruiting|
|Guangzhou, Guangdong, China|
|Contact: lin lizhu, Dr. 13501505588 email@example.com|
|Principal Investigator:||lin lizhu, Dr.||First affiliated hospital of guangzhou university of traditional Chinese medicine|