A prospective, interventional, open-label clinical study to evaluate the safety and efficacy of Febrojith Tablet in the management of pyrexia, immunomodulatory, anti inflammatory effects
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.Changes in fever symptoms from baseline to Day 7 or Day 14 case specific
研究概览
简要总结
Fever/Jvara is a common non-specific symptom experienced by a large number of people and is associated with multiple health conditions. Ayurveda describes fever as Jwara roga. An imbalance between kapha and vata dosha leads to the development of a fever. Jvara is described in Atharvaveda as takman (Son of God Varuna), and drugs like Kustha and Anjana are given to manage this. Various Ayurveda formulations are in practice to limit the fevers of any origi as immune herbs for prevention and curation. Several of these herbs have been extensively studied for their immune-enhancing, modulating and antiviral effects.
Febrojith Tablet consists herbs like Haridra, kirathatiktha, gudoochi, Vasa, papaya leaves etc, it possess antiviral, anti-infective, anti-pyretic and enhances immunity. And will helps reduce high temperature, chills and body aches! AVP Febrojith tablets combine the goodness of natural herbs to support the body in its fight against infections.
Effectively helps reduce high body temperature
Beneficial in various types of infections
Helps relieve chills and body aches
A powerful blend of proven Ayurveda herbs
Supports immune system functions
The study will be carried out per the protocol and with principles of the Good Clinical Practice (GCP) i and any regulatory authoritys requirements
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 2 to 60 years both male and female.
- •2.Subject diagnosed with fever (moderate to high grade).
- •3.Subjects willing and able to provide informed consent voluntarily.
排除标准
- •1.Pregnant or Breast feeding.
- •2.Inability to provide voluntary consent.
- •3.Volunteers who have participated in any drug research study within past 3 months 4.Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
- •5.Any clinically significant medical history medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject impact validity of the study results or interfere with the completion of study according to the protocol.
- •6.History of cancer including solid tumors hematologic malignancies and carcinoma in situ.
- •7.Use of any anti psychotic drugs in the past.
- •8.Subjects who abuse drugs or alcohol drug screening not required.
- •9.Use of any investigational medication within 4 weeks prior to start of study drug.
结局指标
主要结局
1.Changes in fever symptoms from baseline to Day 7 or Day 14 case specific
时间窗: Day to Day 7 and Day 14
2.Changes in immune levels from baseline to Day 7 or Day 14 case specific, considering essential blood parameters such as Total Count, Differential Count, and Hb.
时间窗: Day to Day 7 and Day 14
3.Changes in inflammatory markers from baseline to Day 7 or Day 14 case-specific.
时间窗: Day to Day 7 and Day 14
次要结局
- 1.Incidence and Rate of adverse events from base line to Day 7 or Day 14 case specific.(2.To evaluate consumer acceptance as well as their response toward the product through a feedback questionnaire.)
研究者
Dr AmbrishC
Medstar Speciality Hospital