A RANDOMIZED, OPEN LABEL, PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CLEVIRA IN FEVER OF VIRAL ORIGIN
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Assessment of efficacy parameters namely platelet count, haematocrit, prothrombin time, bleeding time, clotting time – baseline & on each day from day 1 to day 3 and on days 5 & 7 (For 24 subjects who suffer from viral fever with thrombocytopenia)
研究概览
简要总结
| Participants will be randomized into 4 groups with 12 patients in each group. |
· Group 1 – Patients diagnosed as viral fever with thrombocytopenia will receive treatment as per the Ayurvedhic physician advice .
· Group 2 - Patients diagnosed as viral fever with thrombocytopenia will receive treatment as per the Ayurvedhic physician advice. In addition tablet CLEVIRA will be given twice daily for 7 days.
· Group 3 – Patients diagnosed as viral fever other than fever with thrombocytopenia will receive treatment as per the Ayurvedhic physician advice .
· Group 4 - Patients diagnosed as viral fever other than fever with thrombocytopenia will receive treatment as per the Ayurvedhic physician advice. In addition tablet CLEVIRA will be given twice daily for 7 days.
| Assessment of efficacy parameters namely platelet count, haematocrit, prothrombin time, bleeding time, clotting time – baseline & on each day from day 1 to day 3 and on days 5 & 7 (For 24 subjects who suffer from viral fever with thrombocytopenia).Assessment of clinical parameters namely temperature, fever score, arthralgia,myalgia, headache and loss of appetite - baseline and on days 2,4 & 7. (Forall 48 subjects). Adverse events and quality of life will be monitored throughout the study period. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Proper written informed consent obtained from the patient before any procedure performed.
- •Males and females between the age of 18-75 years with an oral temperature of more than 38.0°C (100.4°F).
- •with or without associated rash, body pain and joint pain, severe headache especially behind the eyes, nausea and vomiting.
- •Patients having Viral fever with thrombocytopenia, with a platelet count between 80,000 /micro litre to100,000/micro litre.
- •Subjects with stable vitals like pulse and blood pressure 5.
排除标准
- •Patients with Dengue hemorrhagic fever grade III and IV
- •Patients with platelet count less than 80,000/micro litre.
- •Pregnant or lactating women
- •Patients who have received blood or blood products transfusion during the current illness
- •Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia
- •Patients who have a serum ALT level 3 times higher than the upper limit of the normal range (>165 U/L),
- •Impaired renal function with serum creatinine > 1.5 mg/dl (males) and > 1.4 mg/dl (females),
- •Hypersensitivity to any of the components of the formulation,
- •The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
结局指标
主要结局
Assessment of efficacy parameters namely platelet count, haematocrit, prothrombin time, bleeding time, clotting time – baseline & on each day from day 1 to day 3 and on days 5 & 7 (For 24 subjects who suffer from viral fever with thrombocytopenia)
时间窗: Day 1 to 7
Assessment of clinical parameters namely temperature, fever score, arthralgia, myalgia, headache and loss of appetite - baseline and on days 2,4 & 7. (For all 48 subjects)
时间窗: Day 1 to 7
次要结局
- To monitor for any adverse events during the study period and assess the quality of life using a pre-and post-feedback questionnaire(day 1 to 7)