A Prospective, Single Center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Broken Ganoderma Lucidum Spore Powder on Quality of Life and Immune Function in Patients With Diffuse Large B-cell Lymphoma After Chemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Th1 / Th2 cytokines
研究概览
简要总结
The purpose of this study was to explore the effect of broken Ganoderma lucidum spore powder on improving the quality of life and immune recovery of patients after chemotherapy. Objective To observe the adjuvant treatment with broken wall Ganoderma lucidum spore powder in patients with diffuse large B-cell lymphoma after standard chemotherapy according to NCCN guidelines. To evaluate and compare the immunoglobulin (IGA, IgM, IgG), T cell subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +), Th1 / Th2 cytokine determination, quality of life score, leukocyte recovery rate, infection rate, infection rate To evaluate the effect of Ganoderma lucidum spore powder in improving the quality of life and immune function of patients after chemotherapy. At the same time, the liver and kidney function and adverse drug events were closely monitored during the study to explore the clinical safety of wall broken Ganoderma lucidum spore powder as adjuvant drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diffuse large B-cell lymphoma，NOS
- •all patients were diagnosed for the first time
- •between 18-75 years old, male and female
- •ECoG 0-3 ，the expected survival was more than 6 months
- •the pregnancy test of women of childbearing age was negative; Male and female patients should agree to take effective contraceptive measures during the treatment period and one year of follow-up;
- •sign the informed consent before the test screening
排除标准
- •those who are known to be allergic to the study drug or its related components; Or allergic patients
- •uncontrolled psychosis
- •participating in other trials at the same time, and using experimental drugs that may affect the efficacy and safety evaluation
- •impairment of liver and kidney function
- •HIV antibody positive;
- •HBsAg positive hepatitis B carriers and confirmed hepatitis B and C patients;
- •pregnant or lactating women and patients who do not agree to take effective contraceptive measures;
- •the patient is unable to swallow the capsule or has a disease or condition that seriously affects the gastrointestinal function;
结局指标
主要结局
Th1 / Th2 cytokines
时间窗: half a year
Detection of immunoglobulin (IGA, IgM, IgG)
时间窗: half a year
T cell subsets
时间窗: half a year
T cell subsets (CD3 +, CD4 +, CD8 +, CD4 + / CD8 +)
次要结局
未报告次要终点