A Prospective, Placebo Controlled Study on Caripill Tablet in Management ofChemotherapy induced Thrombocytopenia in solid tumors
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- primary objective of this study is to evaluate the efficacy of CARIPILL
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of CARIPILL Tablet in adult patients with grade I to grade III chemotherapy induced thrombocytopenia (CIT) in solid tumors by assessing the response of platelet count relative to the placebo group
Thrombocytopenia is a common problem in patients with cancer. It can result from chemotherapy or radiation or from underlying disease. Thrombocytopenia creates number of problems in the care of a cancer patients like increased spontaneous bleeding, surgical procedure might be complicated by bleeding, reduction of the dose and intensity of chemotherapy or radiation may be required, effective regimens might be avoided due to the fear of worsening of thrombocytopenia and sometimes treatment might be even be precluded.
The phytochemical analysis of the papaya leaves has shown that they contain saponins, cardiac glycosides, and alkaloids. C. papaya Leaves are a rich source of mineral elements such as Ca, Mg, Na, K, Fe, and Mn.
The therapeutic effects of aqueous extract of papaya (Carica papaya) leaves are presumed to be due to several active components such as papain, chymopapain, cystatin, L-tocopherol, ascorbic acid, flavonoids, cyanogenic glucosides and glucosinolates. These are antioxidants that reduce lipid peroxidation, exhibit antitumor activity and immune modulatory effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18-75 years
- •Has, grade I to Grade III thrombocytopenia as per CTCAE criteria version 4.0
- •Patients undergoing chemotherapy
- •Patients with non-hematological malignancies
- •Willing and able to sign written informed consent.
排除标准
- •Present, or history of, acute pro-myelocytic leukemia (APML), immune thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic-uremic syndrome (HUS)
- •Recent history of major surgery (within 2 weeks of study entry)
- •Currently taking, or participating in a study involving, platelet substitutes, platelet growth factors, or pharmacologic agents intended to enhance or decrease platelet hemostatic function
- •Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study
- •Current HIV infection or hepatitis B virus or hepatitis C virus infections
- •Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP.
- •Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- •Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period
- •Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test Patients who are deemed unsuitable for the study by the investigator
- •Patients with palpable splenomegaly greter than or equalto 16cm below coastal margin
- •Female subjects who are pregnant or breastfeeding.
- •Women of childbearing potential are required to have a BHCG serum or urine pregnancy test performed within 7 days prior to first study drug dose.
- •A female of childbearing potential is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
- •Previously enrolled in this study.
结局指标
主要结局
primary objective of this study is to evaluate the efficacy of CARIPILL
时间窗: Through out chemotherapy cycle
Tablet in adult patients with grade I to grade III chemotherapy induced
时间窗: Through out chemotherapy cycle
thrombocytopenia (CIT) in solid tumors by assessing the response of platelet
时间窗: Through out chemotherapy cycle
count relative to the placebo group.
时间窗: Through out chemotherapy cycle
次要结局
- to evaluate WBS and RBC count(Through out chemotherapy cycle)