CTRI/2021/02/031390
Completed
Phase 4
An active post marketing surveillance to evaluate the safety and efficacy of a fixed-dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 4 mg tablet in symptomatic treatment of common cold in adults.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zuventus Healthcare Limited
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients of either gender of age between \>\=18 years to 60 years.
- •2\.Patients with symptoms of common cold of recent onset, for more than 6 hours and less than 72 hours.
- •3\.Patients willing to give written informed consent.
Exclusion Criteria
- •1\.Hypersensitivity to any of the ingredients of the formulation.
- •2\.Patients taking a monoamine oxidase inhibitor (MAOI), or barbiturates
- •3\.Pregnancy or breastfeeding women.
- •4\.Patients with hepatocellular insufficiency and in patients with hepatic failure or active liver disease.
- •5\.Patients who took an Antihistamine, Analgesic or Decongestant 1 day prior to study enrollment.
- •6\.Patients otherwise judged to be inappropriate for inclusion in the study by the investigator
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
A post-marketing study of the marketed product Maxtra® P syrup for the evaluation of safety and effects in children having common cold.Health Condition 1: J00- Acute nasopharyngitis [common cold]CTRI/2021/02/031189Zuventus Healthcare Limited200
Completed
Phase 4
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of basic Fibroblast Growth Factor Compared to Placebo in Combination with NBUVB for the Treatment of VitiligoIRCT20201104049265N1Imen Vaccine Alborz88
Recruiting
Phase 4
A post marketing study to evaluate safety and effectiveness of Remogliflozin and Remogliflozin-Metformin Combination in treatment of Diabetes patientsHealth Condition 1: E119- Type 2 diabetes mellitus without complicationsCTRI/2019/11/022062Glenmark Pharmaceuticals Ltd
Active, not recruiting
Phase 4
A Clinical trial to evaluate the safety of measles & Rubella vaccine in healthy child having the age of 9 to 12 monthsCTRI/2022/10/046225Zydus Lifesciences Limited
Completed
Phase 4
A Study to assess the safety of Vildagliptin Tablets 100 mg available in market.Health Condition 1: E119- Type 2 diabetes mellitus without complicationsCTRI/2023/07/055146Eris Lifesciences Ltd.205