CTRI/2023/06/053738招募中3 期
A Double-Blind Randomized, Placebo-Controlled, Two-Arm, Parallel-Group, Clinical Study to Evaluate the Safety & Efficacy of Caripap PE (Carica papaya Leaf Extract plus Cucurbita pepo Seed Extract) Compared to Placebo in the Management of Chemotherapy Induced Thrombocytopenia in Patients with Solid Tumors
Med Manor Organics Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Subjects of both genders aged between 18 to 75 years.
- •2.Subjects undergoing chemotherapy for non hematological malignancies.
- •3.Willing and able to sign written informed consent
排除标准
- •1.Present or past history of acute pro-myelocytic leukemia (APML), immune thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic-uremic syndrome (HUS).
- •2.Recent history of major surgery (within 2 weeks of study entry).
- •3.Currently taking, or participating in a study involving, platelet substitutes, platelet growth factors, or pharmacologic agents intended to enhance or decrease platelet hemostatic function.
- •4.Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
- •5.Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- •6.Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP.
- •7.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).
- •8.Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- •9.Subjects with known diagnosis of autoimmune diseases, established in the medical history and / or laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- •10.Subjects who are deemed unsuitable for the study by the investigator.
- •11.Subjects with palpable splenomegaly =16 cm below subcostal margin.
- •12.Female subjects who are pregnant or breastfeeding. Women of childbearing potential are required to have a urine pregnancy test or serum ß-HCG performed within 3 days prior to first study drug dose. A female subject of childbearing potential is a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy; or 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.
- •13.Subjects who had previously enrolled in this study.
研究者
相似试验
进行中（未招募）
不适用
Study to evaluate the effects of BMS-813160 on protein loss in the urine of subjects with type 2 diabetes and diabetic kidney diseaseDiabetic kidney diseaseMedDRA version: 18.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-005093-54-FRBristol-Myers Squibb International Corporation120
进行中（未招募）
不适用
Study to evaluate the effects of BMS-813160 on protein loss in the urine of subjects with type 2 diabetes and diabetic kidney diseaseEUCTR2012-005093-54-DKBristol-Myers Squibb International Corporation120
进行中（未招募）
不适用
ot applicableEUCTR2010-022976-29-ATFlexion Therapeutics, Inc.128
进行中（未招募）
不适用
ot applicableTreatment of Pain in osteoarthritis of the kneeEUCTR2010-022976-29-GBFlexion Therapeutics, Inc.128
已完成
不适用
A Randomised, Double-Blind, Placebo-Controlled, Two-Sequence, Two-Period, Crossover Study to Evaluate the Effect of SMP-028 on Oral Contraceptive Pharmacokinetics in Healthy Female Subjectschronic inflammation of the lungs10006436asthmaNL-OMON34656Dainippon Sumitomo Pharma Europe Ltd.30