Tumor related anemia (deficiency of liver and kidney, deficiency of both qi and blood)
Conditions
Interventions
Test group:nothing
control group:nothing
Sponsors
Dongzhimen Hospital of Beijing University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 = 80g/l; 7. KPS score >= 70; 8. Patients with an estimated survival time of more than 3 months; 9. ALT and AST < 1.5 times of the upper limit of normal value, TBIL < 1.5 times of the upper limit of normal value, and SCR = 2 times of the upper limit of normal value; 10. Informed consent, voluntary participation in the clinical trial, and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with bone marrow metastasis or definite brain and liver metastasis; 2. Patients with uncontrolled severe hypertension (SBP >+ 160mmhg, DBP >= 110mmhg) or severe infection; 3. Patients with previous history of thrombosis, blood disease or ineffective treatment with drugs of the same therapeutic effect; 4. Select the patients who have been treated with drugs of the same kind (EPO or iron and other Western drugs with the effect of improving anemia, or traditional Chinese medicine preparations or decoction pieces with the same effect as Shengxuebao mixture) within the first month or currently, and the patients who have been using hormone drugs for a long time; 5. Patients receiving Western medicine anti-tumor treatment within 1 month before screening; 6. Patients with a history of blood transfusion or currently undergoing blood transfusion (whole blood or red blood cell) treatment within the first 4 weeks of screening: 7. Patients with other serious heart, liver, kidney, hematopoietic system and other important organs and system primary diseases; 8. Those who are unable to cooperate or unwilling to cooperate due to neurological or mental disorders; 9. Allergic constitution or allergic to the ingredients of this product; 10. Have a history of alcohol and drug abuse, or other conditions that reduce the possibility of or complicate the enrollment according to the judgment of the researcher; 11. Pregnant, lactating women, planned pregnancy or those who refuse to use contraceptives during the study period and within 1 month after the last administration of the test drug (including men and women); 12. Those who participated in other clinical studies within 3 months before screening; 13. Subjects considered by the investigator as unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin improvement rate at the 4th week;Improvement rate of TCM syndromes at the 4th week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of hemoglobin value at the 2nd, 4th and 6th week of medication;Changes in red blood cell count at the 2nd, 4th and 6th week after administration;Changes in mean red blood cell volume at the 2nd, 4th and 6th week after administration;Changes of TCM syndrome score compared with baseline at the 2nd, 4th and 6th week of medication;Changes of TCM single symptom scores relative to baseline at the 2nd, 4th and 6th week of medication;Changes in KPS scores relative to baseline at the 2nd, 4th and 6th week of administration; | — |
Countries
China
Contacts
Public ContactLi Hou
Outcome results
None listed