Single Blind, Placebo Control Phase III Study of Insty Granules to Evaluate its Efficacy and Safety

Abstract

Aims and objectives: Cold symptoms are well recognized as sore throat, nasal congestion and clogging, sneezing, coughing, headache and fatigue. This clinical trial was conducted to evaluate the efficacy and safety of Insty granules, at Taj Medical Complex Hamdard Hospital.

Introduction: Up to 499.99 million incidents of acute upper respiratory tract infection (i.e. the common cold) are estimated in the United States each year, with a cost associated with 39.99 billion dollars yearly. The common cold is one of the leading causes of work or school absenteeism and is responsible for an estimated 110 million doctor visits and 6 million emergency visits each year in the United States.

Method: This was a single blind, placebo control phase III clinical trial. Total 662 patients were enrolled in the study, in which 331 receive the Insty granules and 331 receive the placebo.The age range of patients was 19 years to above 50 years. The sample paired t-test was applied to evaluate the significant level.  

Results: Insty granules was very effective in the treatment of cold and flu symptoms.

Conclusion: The Instygranules was safe and well tolerated in all patients and none of the patient reported any side effect.