A clinical study on efficacy of fevogrit in treatment of fever A single arm open label observational study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reduction in fever in the first four hours after the first dose of fevogrit
研究概览
简要总结
This study will be observational, prospective and open label to evaluate the changes in temperature of the patient who will be taking Fevogrit as prescribed by Ayurvedic practitioner. Eligible patient based on the inclusion criteria, will be assessed for their time without fever (<37.2°C) in the first four hours after the first dose of Fevogrit and the time of first occurrence of normal temperature (fever clearance), time without fever over 24 hours of enrolment.The primary outcome measure in this study will be the reduction in body temperature after treatment. It will be initially measured and compared on hourly basis and later at progressively larger intervals. The body temperature will be measured orally by means of a standard doctor’s thermometer in 0F at the start of the treatment and on hourly basis during the first 4 h. It will be taken at 4 h intervals during the next 8 h, at 6 h intervals during the subsequent 12 h and at 12 h intervals for the next 2 days. In addition to the temperature measurement, the patients and their attendants will be given elaborate instructions to measure the patients’ body temperature and record the same in a patient diary card for fever supplied to them
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Both gender with age limit 18 to 60 years Body temperature more than 99°F (37.2°C) Willing to participate and give consent for the study.
排除标准
- •Subject on antipyretic, antibiotic, and steroidal medication within the previous 8-12 hours Any acute or chronic condition that would limit the ability of the patient to participate in the study (Renal, Cardiac disease, Liver disease, or hematologic disorders, bronchial asthma, peptic ulcer disease, and frequent vomiting) Any condition the investigator identifies that can confound the participants ability to properly participate in the study Pregnancy or lactation, intention to pregnancy Known case of Hypothyroidism & Endocrine disease condition.
结局指标
主要结局
Reduction in fever in the first four hours after the first dose of fevogrit
时间窗: Baseline 1hr 2hr 3hr 4hr 8hr | Day 2 | Day 3
次要结局
- First occurrence of normal temperature
研究者
Dr C B Dhanraj
Patanjali Ayurved Hospital Patnjali Yogpeeth (Trust)
