Status:
UNKNOWN
Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(BCS) With Digestive Tract .
Lead Sponsor:
Livzon Pharmaceutical Group Inc.
Conditions:
Carcinogenic Fatigue
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The efficacy and safety of cancer patients in patients with gastrointestinal cancer (Palliative care) in patients with gastrointestinal tumor (chemotherapy) were prospectively, randomized blind, multi...
Detailed Description
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 qu...
Eligibility Criteria
Inclusion
- 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
- 1\. Any situation that may hinder the subject from completing the clinical trial, including but not limited to serious, uncontrollable organic disease or infection:
- clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, etc.
- serious clinical infection of activity (greater than 3 degrees nci-ctcae 4.03)
- uncontrolled hypertension (systolic pressure is greater than 160 mmHg or diastolic pressure is greater than 100 mmHg, despite the best drug treatment);
- 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.
- other diseases that need to be controlled: pulmonary congestion, etc.
- 2\. Patients with symptoms, uncontrollable nerves, mental illness or mental disorders;
- 3\. Compliance.
Key Trial Info
Start Date :
January 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03456609
Start Date
January 18 2018
End Date
December 30 2019
Last Update
March 7 2018
Active Locations (1)
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1
First affiliated hospital of guangzhou university of traditional Chinese medicine
Guangzhou, Guangdong, China