An Open Label, Prospective, Multicentric, Clinical Study to Evaluate the Efficacy and Safety of HCXK 052501 in Pediatric Population with Productive Cough
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
研究概览
简要总结
Title: An Open Label, Prospective, Multicentric, Clinical Study to Evaluate the Efficacy and Safety of HCXK-052501 in Pediatric Population with Productive Cough
Participants: 50
Duration:14 days (Per participants treatment duration)
Product: HCXK-052501 2.5ml for Group 1 and 5ml for Group 2
Visits: Baseline, Day 3 Day 14
Objectives:To evaluate the efficacy and safety of HCXK-052501 in the participants with Productive Cough.
Endpoints: Efficacy Endpoints
•Reduction in cough severity from baseline to EOS using cough visual analogue scale as evaluated by Investigator.
•Percentage of participants showing improvement from cough and related symptoms within 3 days of treatment using cough VAS and clinical symptom evaluation questionnaire as evaluated by Investigator.
•Percentage of participants showing complete relief from cough using cough VAS and clinical symptom evaluation questionnaire as evaluated by Investigator.
•Reduction in cough related symptoms from baseline to EOS using clinical symptom evaluation questionnaire as evaluated by Investigator.
•Time required for onset of action in symptomatic relief from cough symptoms after administration of first dose.
•Change in sputum characteristics using sputum evaluation scale from baseline to day 3 and EOS.
•Assessment of product experience and effectiveness feedback by participants
Safety Endpoints
•Incidence of adverse events during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants who meet all the following criteria will be included in the study: 1.Participants presenting with persistent productive cough due to varied etiology (infective, non-infective, allergic etc.) for less than 3 days duration.
- •2.Participants presenting with one or more of the following symptoms associated with productive cough: sputum, wheezing, chest congestion, fatigue or awakening from night coughs, shortness of breath, difficulty in talking because of respiratory discomfort.
- •3.Participants of either gender aged between more than or equal to 2 to less than or equal to 12 years.
- •4.Participants with mild to moderate cough severity score of 11mm to 70mm on a validated cough visual analogue scale.
- •5.Participants who agree to refrain from using any other similar medication during the study period (e.g., cough syrups, expectorants, antitussives).
- •6.Participants who have not participated in any other clinical trial within the past 3 months of screening.
- •7.Participants/parents who willingly sign informed consent form/oral assent (as applicable) and follow the study procedure as per age group mentioned below: i.Parents/Guardians/Caregiver related to pediatric participants more than or equal to 2 to less than or equal to 7 years willing to give informed consent for his/her child to participate in the study.
- •ii.Participants aged more than or equal to 7 to less than or equal to 12 years of age willing to provide oral assent for his/her participation in the study along with parents/guardians/caregiver consent.
排除标准
- •Participants who meet any one of the following criteria will be excluded from the study: 1.Participants suffering from accompanying illnesses such as bronchiolitis, crepitation in lungs, pneumonia, pleuritis, septic infections, asthma, COPD, fever more than 101 degree F and other chronic respiratory disorders including upper respiratory tract infections with complications.
- •Participants who have received antihistamines, cough suppressants, bronchodilators, mucolytics, expectorants, antibiotics or any other herbal medicines for the control of URTI symptoms 3 days prior to enrollment.
- •3.Participants who are using nebulizer 1 week prior to enrollment to the study.
- •4.Participants with known clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, gastrointestinal, autoimmune, endocrinal, congenital or any other systemic disorder that may interfere with the study conduct and outcome in the opinion of the Investigator.
- •(Participants with any chronic medical condition under control to be also excluded).
- •5.Participants with known history of GI disorders like GERD, Gastritis, abdominal pain, diarrhea, indigestion, or any other discomfort (as assessed by GSRS score more than 2 for any one of the 15 questions to be excluded).
- •6.Any other conditions (physical, psychological or social) that can interfere with the participants’ compliance to the study in the opinion of the Investigator.
- •7.A known history or present condition of allergic response to any of the ingredients present in the investigational product.
- •8.Pre-existing systemic disease necessitating long-term medications.
- •9.Genetic and endocrinal disorders.
- •10.Any history of seasonal or perennial allergic rhinitis.
- •11.Participants/parents whose refused to sign informed consent.
研究者
Dr K N Harsha
Sri Laxmi Hospital