Health Condition 1: J060- Acute laryngopharyngitis
Conditions
Interventions
Intervention1: Placebo syrup: 1 tablespoonful three time in a day for 7 days
Control Intervention1: Co-Ex syrup: 1 tablespoonful three time in a day for 7 days
Sponsors
BHARGAVA PHYTOLAB PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male & Female Volunteers, with age >= 12 years 2.Score greater than or equal to 3 points on the cough severity score 3.Subjects who have not participated in a similar investigation in the past four weeks. 4.Subjects able to provide informed consent. 5.Subject is willing and able to comply with all trial requirements
Exclusion criteria
Exclusion criteria: 1.Pregnancy or risk of pregnancy. 2.Lactation mother 3.Fever above 38º C. 4.Subjects who are on ACE inhibitor drugs 5.Subjects having GERD 6.Subjects with bacterial infections of the upper respiratory tract. 7.Any pathology or past medical condition that can interfere with this protocol 8.Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders 9.Severe neurological or psychological disorders or a history of alcohol or drug abuse. 10.History of allergic reaction to the medications used in the study 11.Use of other investigational drugs within 30 days prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Significant relief from cough using Severity cough score from baseline to visit 3. 2. Significant Reduction in cough using Severity cough score from baseline to EOT 3. Duration of RTIâ??s as assessed from subject diary Timepoint: Baseline, Day 3, Day 5, Day 7 and day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment for safety and tolerability of cough syrup will be evaluated on the basis of subjective symptoms and opinions expressed by the subjects. 2.Changes in total IgG, IgM &IgE from baseline to EOT. 3.Assessment of safety investigational product: 4.Adverse event 5.Biomarker of systemic safety a.Hematological â?? Haemogram b.Hepatic - SGOT, SGPT Timepoint: Baseline, Day 3, Day 5, Day 7 and day 14 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed