A Post Marketing Randomized Placebo Controlled Study to Evaluate the Efficacy of Study Product UPLAT® (Carica Papaya Leaf Extract + Tinospora Cardifolia Extract) in the Cancer Patients With Thrombocytopenia Induced by Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Increase in the platelet counts from baseline levels to the end of therapy.
研究概览
简要总结
Single blind, randomized, multicentric placebo controlled study to evaluate the efficacy of Study product in patient with Chemotherapy induced thrombocytopenia. The Study is divided into [screening visit (visit 1) > baseline and treatment allocation visit (visit 2) >blood collection (visit 3); treatment compliance visit (visit 4) > blood collection (visit 5) >blood collection (visit 6)>end of study visit (visit 7)].
详细描述
UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract), is an orally administered dietary supplement for management of thrombocytopenia. Manufactured bySanat Products Ltd.
Throughout study, it will be designated as product A to maintain study blindness at subject end.
Placebo Throughout study, it will be designated as product B to maintain study blindness at subject end.
Single blind, randomized, multicentric placebo controlled study to evaluate the efficacy of Study product in patient with Chemotherapy induced thrombocytopenia. The Study is divided into [screening visit (visit 1) > baseline and treatment allocation visit (visit 2) >blood collection (visit 3); treatment compliance visit (visit 4) > blood collection (visit 5) >blood collection (visit 6)>end of study visit (visit 7)].
Dose regimen After meeting the inclusion criteria subject will take 4 units daily (2 in morning and 2 in evening) for 10 days. Patients will be called on Day5th, 10th and 15thfor the Complete blood count (Central lab).
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
- Single (Participant)
盲法说明
Single Blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 18-55 years.
- •Subjects must sign with date an informed consent prior to any evaluation and participation in the trial.
- •Patients who were confirmed solid tumour and received at least one cycle of chemotherapy prior to screening visit.
- •Patients with a platelet counts between > 20000 and < 150,000/ml at the time of screening.
排除标准
- •Planning to receive any type of surgery.
- •Pregnant or lactating women.
- •Patients with platelet count less than 20000/ml.
- •Patients with thrombocytopenia presenting with active bleeding.
- •Patients who have received blood or blood product transfusion during the current illness or during past one week.
- •Patients with thrombocytopenia purpura (ITP) leukemia, hemophilia or bleeding diathesis.
- •Participation in another trial with another investigational product
研究组 & 干预措施
A
UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract
Take 4 units daily (2 in morning and 2 in evening) for 10 days
干预措施: UPLAT (Dietary Supplement)
B
Placebo
Take 4 units daily (2 in morning and 2 in evening) for 10 days
干预措施: Placebo (Other)
结局指标
主要结局
Increase in the platelet counts from baseline levels to the end of therapy.
时间窗: Day 15
Increase in the platelet counts from baseline levels to the end of therapy.
次要结局
未报告次要终点