CTRI/2017/07/008954招募中Unknown
A Multi-centric, Double blind, Placebo controlled, Randomized, observational study to evaluate the Efficacy, Safety and tolerability of carica papaya leaf Hydro alcoholic extraction with enriched alkaloids (290 mg) to inhibit Thrombocytopenia induced by Chemotherapy in cancer patients
Katra Phytochem Pvt ltd1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年4月7日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the effect of Papaya Leaf Extract relative to the placebo on the platelet counts
研究概览
简要总结
Carica papayaleaf extract has attracted attentions because of the promising results shown from the various studies conducted in South East Asian countries on the effectiveness of carica papayaleaf extract on increasing the platelet counts in patients with thrombocytopenia
This trial is designed as Multi-centric, double blind, placebo controlled, Randomized, Prospective study in patients aged 18 years and above and having thrombocytopenia associated with anti cancer chemotherapy
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 Platelet count
- •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 8.Patients who are deemed unsuitable for the study by the investigator
- •Patients with palpable splenomegaly greter than or equal to 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: 1) 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.
结局指标
主要结局
To compare the effect of Papaya Leaf Extract relative to the placebo on the platelet counts
时间窗: 21 days | Twice daily
次要结局
- Percentage increase in WBC,RBC and Neutrophil count(Number of chemotherapy dose reduction)
研究者
研究点 (1)
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