clinical efficacy of Shengxuening tablets for cancer anemia:a randomized, double-blind study

Phase 4

• Conditions: Cancer anemia

• Registration Number: ITMCTR2100004715
• Lead Sponsor: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients are diagnosed as gastrointestinal tumours by imaging, pathological and/or cytological;
2. Patients meet the diagnostic criteria for mild or moderate anemia (mild anemia: Hb 90 to 120g/L or moderate anemia: Hb 60 to 90g/L), peripheral blood film shows small cell hypochromic anemia (MCV<80fl, MCH<27pg, MCHC<0.32, or red blood cell morphology may have obvious hypochromic manifestations); serum (plasma) iron <8.95µmol/L (50µg/L); total iron binding capacity>64.44µmol/L (360µg/dl); serum ferritin (SF) <14µg/L or transferrin saturation <0.15.
3. Aged 18 to 75 years;
4. KPS score above 70;
5. Life expecting longer than three months;
6. Any medication not be used to treat anemia and improving fatigue within one month before enrollment;
7. No chemotherapy regimen had been used before enrollment or had been discontinued for at least one month;
8. Voluntary subjects and signed informed consent.

Exclusion Criteria

1. With heart, liver, kidney and other important organ damage.
2. Pregnant women and mental patients.
3. With gastric cancer invading the blood vessels caused by hematemesis, blood in the stool and other major bleeding.
4. Patients did not use the drug as prescribed.
5. Patient was forced to interrupt treatment due to serious side effects during the treatment period.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean red blood cell volume;Hb concentration;Red blood cell distribution width;Hematocrit;Red blood cell count;

Secondary Outcome Measures

Name	Time	Method
Serum ferritin;Karnofsky;Transferrin;Serum iron;Total iron binding capacity;