Clinical trial on Fever patinets
- Conditions
- Health Condition 1: R509- Fever, unspecified
- Registration Number
- CTRI/2024/01/061763
- Lead Sponsor
- The Arya Vaidya Pharmacy Coimbatore Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
4.Patient is willing and able to comply with all trial requirements.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Changes in fever symptoms from baseline to Day 7 or Day 14 case specific <br/ ><br>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. <br/ ><br>3.Changes in inflammatory markers from baseline to Day 7 or Day 14 case-specific.Timepoint: Day to Day 7 and Day 14
- Secondary Outcome Measures
Name Time Method 1.Incidence and Rate of adverse events from base line to Day 7 or Day 14 case specific. <br/ ><br>2.To evaluate consumer acceptance as well as their response toward the product through a feedback questionnaire. <br/ ><br>3.To evaluate general well being after medication (such as quality of sleep, craving for food, bowel movements, taste, digestion, and the ability to perform normal activities)Timepoint: Day 0 Day 7 and Day 14