跳至主要内容
临床试验/CTRI/2024/02/063022
CTRI/2024/02/063022尚未招募Unknown

A clinical study on efficacy of fevogrit in treatment of fever A single arm open label observational study

Patanjlai Research Foundation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月1日最近更新:

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

发起方
Patanjlai Research Foundation
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr C B Dhanraj

Patanjali Ayurved Hospital Patnjali Yogpeeth (Trust)

研究点 (1)

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