A Prospective, Randomized, Assessor-Blinded, Real-world Study to Evaluate the effectiveness and safety of advanced Formulation of FDC of Paracetamol IP 500 mg, Phenylephrine Hydrochloride IP 10 mg, and Chlorpheniramine Maleate IP 2 mg in Adults with Common Cold.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline in modified Jackson’s score
研究概览
简要总结
This is a prospective, randomized, assessor-blinded, real-world study designed to evaluate the effectiveness and safety of an advanced formulation FDC of Paracetamol IP 500 mg, Phenylephrine Hydrochloride IP 10 mg, and Chlorpheniramine Maleate IP 2 mg in adults with common cold. The study will enroll adults aged 18 to 60 years with a Modified Jackson’s Score of >6 at screening and symptoms of common cold of recent onset, lasting more than 6 hours and less than 72 hours. Eligible participants will be randomized at baseline (Day 0) to receive either the test product (advanced formulation) FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg, and Chlorpheniramine Maleate 2 mg tablet, or the reference product (conventional formulation) FDC of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg, and Chlorpheniramine Maleate 2 mg tablet. The primary objective is to compare the efficacy of the advanced formulation versus the conventional formulation FDC, with the primary endpoint being the change from baseline in Modified Jackson’s Score on Day 3 and Day 5. Secondary objectives include comparing safety between the two formulations, assessing time to first noticeable relief, evaluating patient satisfaction on Day 3 and Day 5, and recording the incidence of adverse events (AEs) and serious adverse events (SAEs) related to the study drug.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18 to 60 years 2.Patients with Modified Jacksons Score of greater than 6 at screening.
- •3.Patients with symptoms of common cold of recent onset, for more than 6 hours and less than 72 hours.
- •4.Willing to use effective contraception during the study period (if applicable).
- •5.Willing and able to provide written informed consent.
排除标准
- •1.Allergy to any study medication 2.History of asthma, sinusitis, or chronic respiratory disorders 3.Recent use of cold or allergy medications (less than 24 hours) 4.Participation in another clinical trial within the past 30 days.
- •5.Any condition that, in the investigators judgment, may compromise safety, compliance, or study integrity.
结局指标
主要结局
Change from baseline in modified Jackson’s score
时间窗: At Day 3 and 5
次要结局
- Patient Satisfaction Score(At Day 3 and 5.)
- Time to first noticeable relief after using study Drug(Day 0 to Day 5)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the study drug(Day 0 to Day 5)
研究者
Dr Jayesh Sanmukhani
Clinexcel Research