CTRI/2020/07/026402
Completed
Phase 4
A Prospective, Interventional, Multicenter, Post marketing Clinical Study of fixed dose combination of FLUCOLD TABLET (Paracetamol 500 mg + Phenylephrine HCL 10 mg + Chlorpheniramine maleate 2 mg) Uncoated tablet of Wallace Pharmaceutical Pvt. Ltd., in the Treatment of common cold and flu syndrome in adult population.
Wallace Pharmaceuticals Pvt Ltd0 sites199 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Sponsor
- Wallace Pharmaceuticals Pvt Ltd
- Enrollment
- 199
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or Female having the age of 18 to 55 years.
- •2\.Presented symptoms of recent onset, for more than 6 hours and less than 72 hours, characterizing one of the following conditions:
- •The common cold, which consists of at least 2 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, the latter being of moderate to severe intensity through a symptom severity scale of 4 points
- •3\. Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
Exclusion Criteria
- •1\.Patients who are not willing to give written informed consent.
- •2\.Any known hypersensitivity to the study products.
- •3\.Pregnant and lactating women.
- •4\.Any history of seasonal or perennial allergic rhinitis.
- •5\.Patients who have taken treatment for the presenting symptom within 7 days of screening.
- •6\.Any history of drug abuse /chronic alcoholism
- •7\.Use of monoamine oxidase inhibitors or barbiturates
- •8\.Use of Vitamin C/ascorbic acid or taking supplements or fruits rich in vitamin C.
Outcomes
Primary Outcomes
Not specified
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