Subject: In-Practice Usage and Performance (IPUP) Study of CHERICOF-12;
Study code: IPUP/CHERICOF-12/Physician/Stanlife division/April 2023
Upper respiratory tract infection (URI) represents the most common acute illness evaluated in the outpatient setting. Symptom-based therapy represents the mainstay of URI treatment in immunocompetent patients. The effectiveness of a treatment depends on both the efficacy of a medication and patient adherence to the therapeutic regimen.
Customization of medication regimens to reduce the frequency of administration, and/or reduce the number of different medications, and/or to replace with combination products can be useful.
Stanlife division of Sun Pharma had launched Indian’s first long acting cough formula, under the brand name “CHERICOF-12”, (Each 5 ml of Chericof-12 Contains-Dextromethorphan Polistirex equivalent to Dextromethorphan Hydrobromide IP 30 mg, Chlorpheniramine Polistirex equivalent to Chlorpheniramine Maleate IP 4 mg in a flavoured syrupy base q.s. ) is indicated for the temporary relief of cough, due to throat irritation, sneezing and running nose with every 12 hourly dosing.
Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to-day practice of individual medical practitioners. For this purpose, we have planned to conduct a cross sectional study to assess the real-life performance of ‘CHERICOF-12 in patient’s requiring relief from cough, due to throat irritation, sneezing and running nose.
We invite you to participate in this study. All you need to do is to report on a standard form your experience with ‘CHERICOF-12’ in patients in whom you prescribed this product in the normal course of your practice. Thus, this is not an experimental study because the product was prescribed and purchased as you and your patient’s would normally do..
If you agree to participate, you will need to copy the relevant information from the suggested number of patient’s case papers, and investigational reports, if any (which we call source documents), on to the standard case report forms (which we call CRF).
A monitor will assist you in verifying the CRF with the source documents to ensure that the CRF signed by you are free from errors or omissions. Let us assure you that the CRF will not contain the patients’ names, so as to ensure confidentiality.
If any adverse events (AE) had occurred during ‘CHERICOF-12’ therapy, you will be expected to report them to the monitor or to me immediately on the AE reporting form.
As you will be spending some extra time to keep, copy and verify these patient’s records, we offer to pay you by cheque a professional fee of Rs. {{$contractAmount}}/- .
We trust you and we are partners in promoting safe and effective drug therapy. In that spirit, we hope you will consent to participate in this study. If you do, please sign and return the enclosed reply along with your visiting card for accuracy of records.
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