An open labeled, randomized, comparative study to evaluate the Effectiveness of GanjhuVirTM a herbal antiviral in Cases of Dengue Fever with Thrombocytopenia
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in mean platelet count
研究概览
简要总结
It is an open labeled, randomized,comparative study to evaluate the Effectivenessof GanjhuVirTM a herbal antiviral in Cases of Dengue Fever withThrombocytopenia. he study will be conducted asper computer generated randomization list, subject will either be randomized todrug group or control group in 1:1ratio. Subjects will be advised to take given medication in a dose of 5 mlthrice daily orally after meals with water for 05 days. The primary objectivesof the study will be to assess change in mean platelet count. The secondaryobjectives will be to assess for overall improvement, percentage ofparticipants with adverse events, vitals, tolerability of study drugs andchanges in myalgia recovery from baseline to 5 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or Female Subject aged between 18 and 60 years 2.Diagnosis confirmed as DF Grade
- •3.Platelet count is below 100,000 and above 30,000 per µL 4.ALT/SGPT level less than 165 U/L 5.Subject willingly giving written informed consent.
排除标准
- •1.Patient diagnosed with DHF Grade 3 or 4 2.Platelet levels are less than 30,000 per µL 3.Patient is either pregnant or lactating 4.Has received blood products or blood transfusion during the current hospital stay Or during last one month 5.Is the patient diagnosed with ITP, Leukaemia or Hemophilia 6.Serum Creatinine is more than 1.4 mg/dl (if female) or 1.5mg/dl (if male) 7.Patient has participated in another trial within past one month 8.Patient with positive HIV infection 9.The investigator can exclude patient at his/her discretion depending upon the condition of the patient.
结局指标
主要结局
Change in mean platelet count
时间窗: Screening visit, Visit 1 Day1,Visit 2 Day3, Visit 3 Day5
次要结局
- Change in global assessment for overall improvement(Percentage of participants with adverse events)