跳至主要内容
临床试验/CTRI/2023/07/055248
CTRI/2023/07/055248尚未招募2/3 期

A Randomized Controlled Clinical study to evaluate the antipyretic effect of Febrikid Plus Tablets in children with febrile state.

Parul Ayurveda Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Reduced in Body ache & headache

研究概览

简要总结

Feveris very primary clinical feature of most of illnesses and it is very primarysign that lead to individual for seeking the medical aid and forcing thephysician to investigate the case. Ranging from the simplestcommon cold to severe most carcinomatous situation, fever is the important signwhich can’t be ignored. Fevercauses the feeling of uneasiness and discomfort, along with loss of appetite,tastelessness, irritability as its cardinal subjective feeling.

Apartfrom this increase in body temperature is alarming physiological sign whichshould be taken in account on priority basis.

Therefore,to reduce the body temperature is the main aim of therapy while treating feveras disease or fever as symptom of other underlying disease.

Reductionin body temperature is achieved with different mean in Allopathic medicineaiming mainly as antipyretic effect. Paracetamol, Ibuprofen, mefenamic acid,diclofenac sodium are different antipyretics are in used since long time, andthis entire agent are found to be effective and safe in recommended doses.

Thoughthis agent reduces the body temperature readily, in many cases there is noeffect of antipyreticpharmacological agent on pathology of underlying diseases and hence these drugshave only role in symptomatic relief of body temperature, pain etc.

This Trial is designed to evaluate the efficacy of Ayurveda Antipyretic for Children . As to develop the ayurveda antipyretic drug which acts quickly on symptom and as well on its pathology.

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
3.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Temperature between 99- 103 oF.
  • 2.Fever of acute onset without any complications i.e. dehydration, convulsion, etc.
  • 3.Acute onset fever of 1 to 3 days.
  • 4.Patient of either sex suffering from fever of age 3-12 years.

排除标准

  • 1.Fever more than 3 days.
  • 2.Chronic fever (> 5 days) associated with poor hemodynamic and clinical outcomes.
  • 3.Any febrile condition of children requiring an immediate intervention depending of history and general condition at the point of examination as found by the investigators non inducible was be excluded from study.

结局指标

主要结局

Reduced in Body ache & headache

时间窗: At baseline | On Day 2 | Day 3 | Day 5

Reduced in Fever & Body Temerature

时间窗: At baseline | On Day 2 | Day 3 | Day 5

Improvement in appetite

时间窗: At baseline | On Day 2 | Day 3 | Day 5

次要结局

  • Improvement in Leg cramps(Improvement in Weakness)

研究者

发起方
Parul Ayurveda Hospital
申办方类型
Research institution and hospital

研究点 (1)

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