CTRI/2020/11/029254尚未招募2/3 期
An Open Label, Single Arm, Pilot Clinical study To Evaluate The Efficacy and Safety of HPLT031707 SYRUP in Cases of Thrombocytopenia due to varied etiology in Pediatric Population.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Increase in platelet counts as compared to baseline
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female pediatric subjects between the age group of ≥2 years to ≤ 12 years
- •Paediatric subjects who are diagnosed with thrombocytopenia (platelet count between 50000 cells/mm3 to 1 Lakh cells/mm3) due to any of the following conditions: i Infection conditions which are associated with mild to moderate thrombocytopenia viz., associated with dengue fever, malaria, typhoid ii Any other chronic conditions which require transient increase in platelet counts (like injection, tooth extract or injury) to avoid any possible bleeding). • Acute Immune thrombocytopenic purpura (ITP) • Post-Viral infections/ Post Immunization such as Hepatitis C, B, H1N1 and MMR. iii Exposure to certain medications or toxins: Other than drugs/ toxins causing drug-induced hypoplasia of the bone marrow • Sedatives and anticonvulsant agents (carbamazepine, phenytoin, valproic acid) • Analgesic agents (acetaminophen, diclofenac, naproxen) • Diuretic agents – chlorothiazide • Heparins (Unfractionated heparin, low-molecular-weight heparin) • Cinchona alkaloids (quinine, quinidine) • Platelet inhibitors (abciximab, eptifibatide, tirofiban) • Antirheumatic agents (Gold salts, D-penicillamine) • Antimicrobial agents (linezolid, rifampin, sulfonamides, vancomycin) • Histamine-receptor antagonists.
- •cimetidine
- •Parents/Guardians/Caregiver related to paediatric subject willing to give written informed consent for his/her child to participate in the study
- •Paediatric subject aged > 7 years of age willing to provide oral assent for his/her participation in the study.
- •Paediatric subjects who have not participated in this kind of trial in the past 4 weeks.
排除标准
- •Paediatric subjects with platelet count <50000/μL or more than 1 Lakh cells/mm
- •Paediatric subjects weighing <10 Kgs and >45Kgs.
- •Paediatric subjects with any febrile condition with temperature >103 0F and with a history of any febrile seizures
- •Paediatric subjects presenting with haemorrhagic phenomena at Day 1 (screening/baseline) e.g. evidence of petechiae, ecchymoses, bleeding from the oral mucosa, gastrointestinal tract (hematemesis or melaena.), injection sites or other locations.
- •Paediatric subjects diagnosed with any haemorrhagic phenomenon or shock as assessed by hypotension, hypovolemia and dehydration
- •Paediatric subjects with the history of juvenile diabetes mellitus treated with medication.
- •Paediatric subjects with a history of established hematological disorders including leukemia and hemophilia.
- •Paediatric subjects with a history of established malignancy, which requires cytotoxic chemotherapy.
- •Paediatric subjects who have received blood products or blood/platelet transfusion within one month of screening.
- •Paediatric subjects who are hypersensitive to any of the ingredients of the study medication.
结局指标
主要结局
Increase in platelet counts as compared to baseline
时间窗: Day-1 to Day-7
次要结局
- 1. Time taken to achieve a platelet count of 1.5 Lakh cells/mm3(2. Overall compliance of the subject to the study medication)
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
2 期
Role of HPLT031707 SYRUP in low platelet count among children due to varied etiology.CTRI/2020/11/029254The Himalaya Drug Company
已完成
不适用
A pilot study to evaluate the safety and advantages of CurQfen on brain function in middle aged to elderly people.CTRI/2018/03/012393Akay Flavours and Aromatics Private Limited6
已完成
不适用
A clinical study to assess the effect of a herbal product named Glysikot granules in patients with Type 2 Diabetes MelitusCTRI/2012/11/003123Clinfound Clinical Research Services P Ltd50
已完成
不适用
Scientific Evaluation of an Ayurveda medicine in tablet form in Diabetic patientsCTRI/2013/08/003868Clinfound Clinical Research Services Pvt Ltd
进行中（未招募）
不适用
A clinical study of DIADROPSZ, an ayurvedic product in treatment of Type 2 Diabetes MelitusCTRI/2017/03/008057Clinfound Clinical Research Services PvtLtd50