CTRI/2013/08/003919已完成未知
AN OPEN LABEL, MULTICENTER, CONTROLLED CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF DNT -53 IN PATIENTS WITH LOW PLATELET COUNT.
OmMedi PharmaceuticalsPvtLtd0 个研究点目标入组 72 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 72
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
- •Patients with the age group of 18 to 60 Years
- •Willing to Sign on informed consent accordance with GCP and local legislation
- •Patients with low Platelet count (Lower Limit- Greater than or equal to 80,000 per micro liter).
- •Patient suffering from severe infectious disease in which the platelet count is generally lower.
- •Patient suffering with diseases like Malaria, Vitamin B12 (or) folate deficiency, certain viral & bacterial infections, in which the platelet count is below normal range.
排除标准
- •Patient not willing to comply with the study procedure.
- •Patients having the platelet count less than 80,000 per micro liter.
- •Pregnant or Lactating women
- •Other serious medical illness likely to interfere with study participation
- •Significant psychiatric illness, senility, dementia or substance abuse
- •Drug abuse within the 3 months prior to informed consent that would interfere with trial participation
- •Participation in another trial within 3 months prior to informed consent
- •Dehydration by clinical judgment of the investigator
- •Any contraindication to blood sampling.
- •Severe reduction in kidney function OR removal of a kidney OR kidney transplant.
- •Severe asthma that is poorly controlled with medication.
- •HIV Positive serology.
- •Certain medications that may interfere with the study medication (these will be identified by the study Investigator).
研究者
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