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
shenqifuzheng injection
+ Sodium Chloride Injection 0.9%
Treatment Study
Summary
Study start date: January 18, 2018
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * 1\. Patients with gastric cancer, esophageal cancer or colorectal cancer diagnosed by pathology or cytology; * 2\. Diagnostic criteria for cancer-related fatigue; * 3\. Syndrome differentiation of Chinese medicine is a syndrome of lung temper; * 4\. Estimated survival over 3 months; * 5\. ECOG score is less than or equal to 3 * 6\. Age 18 \~ 80 years old； * 7\. Non-surgical indications or reluctance to operate the surgical treatment; * 8\. 70 g/L or higher HGB; * 9\. Stop and chemotherapy for more than 1 month; * 10\. The patient is willing to accept the treatment of the programme, and can follow the doctor's advice to take the medicine and comply with the patient. Exclusion Criteria: * 1\. Any situation that may hinder the subject from completing the clinical trial, including but not limited to serious, uncontrollable organic disease or infection: 1. clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, etc. 2. serious clinical infection of activity (greater than 3 degrees nci-ctcae 4.03) 3. uncontrolled hypertension (systolic pressure is greater than 160 mmHg or diastolic pressure is greater than 100 mmHg, despite the best drug treatment); 4. severe liver and kidney function abnormality (blood creatinine is greater than 1.5 times ULN; ALT or AST is greater than 5 times ULN; Bilirubin is greater than 1.5 times ULN. 5. other diseases that need to be controlled: pulmonary congestion, etc. * 2\. Patients with symptoms, uncontrollable nerves, mental illness or mental disorders; * 3\. Compliance.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
First affiliated hospital of guangzhou university of traditional Chinese medicine
Guangzhou, ChinaOpen First affiliated hospital of guangzhou university of traditional Chinese medicine in Google Maps