Health Condition 1: R509- Fever, unspecified
Conditions
Interventions
Intervention1: Febrojith Tablet: Dosage form: Tablet
Dose:175mg
Duration: 7 days
Age: 2-6 (½ to 1 tablet)-Twice or three times a day
Age:6-18 (1 to 2 tablet)-Twice or three times a day
Age:18 above:2
Sponsors
The Arya Vaidya Pharmacy Coimbatore Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in fever symptoms from baseline to Day 7 or Day 14 case specific 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. 3.Changes in inflammatory markers from baseline to Day 7 or Day 14 case-specific.Timepoint: Day to Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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 | — |
Countries
India
Contacts
Public ContactDr Sindhu Sreejith
The Arya Vaidya Pharmacy (Coimbatore) Ltd
Outcome results
None listed