A clinical trial to study the effects of combination drug in patients suffering from Dry Cough associated with sneezing and running nose or throat irritation.
- Conditions
- Health Condition 1: J069- Acute upper respiratory infection,unspecified
- Registration Number
- CTRI/2022/11/047227
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patient of either gender aged more than or equal to 6 years and ready to give written informed consent/assent to participate in the study at the time of screening
An additional written informed consent will be taken from Parent or legally acceptable representative (as applicable) in case assent is taken from patient aged more than or equal to 6 years and less than 18 years
Patient suffering from dry cough associated with sneezing and/or running nose and or throat irritation
Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (such contraception may include hormonal birth control example combined estrogen and progestogen containing [oral, intravaginal, or transdermal]
or progesterone only [oral injectable or implantable] hormonal contraception associated with inhibition of ovulation intrauterine devices intrauterine hormone releasing system OR bilateral tubal occlusion vasectomized partner or total sexual abstinence)
Patient with chronic cough that occurs due to smoking, asthma or COPD or any other reasons
Patient with clinically significant conditions including but not limited to: pulmonary (e.g. bronchitis, bronchiectasis or asthma), central nervous system (e.g. epilepsy), severe hypertension (seated systolic >= 180 mmHg, or seated diastolic >= 110 mmHg), glaucoma, ocular hypertension (IOP > 21 mmHg), severe hepatic impairment (Child Pugh Class C) and severe renal impairment (eGFR < 15 ml/min)
Patient with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose
Malabsorption
Patient with history of HIV, Hepatitis B and Hepatitis C
Patient used any medication or herbal remedies to treat cold and cough prior to screening (antibiotics in the last 14 days, antitussive or antihistamines or decongestant or herbal remedies in the last 72 hours, medicated lozenge in the last 24 hours)
Patient who have used monoamine oxidase inhibitors within 14 days prior to screening
Patient with a history of allergic response to any of the investigational product and/or its components
Patient with current diagnosis of substance abuse (as per DSM-5) or history of alcohol or drug abuse
in the past 3 months prior to screening visit
Patient who has participated in another investigational study within 30 days prior to screening of this
study or planning to participate during the study
Female patient who is pregnant and /or lactating
Patient judged unfit for this study by investigator
Investigator, study personnel, sponsor representatives and their first degree relatives
Patient operating heavy complex machinery or who intend to drive
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment includes Treatment Emergent Adverse Events (TEAEs) reported during the study <br/ ><br>Change in severity of cough as per cough severity scoreTimepoint: Baseline,Day 7
- Secondary Outcome Measures
Name Time Method Change in frequency of cough (recorded since last 24 hours) as per Likert scale <br/ ><br>Change in severity of sneezing as per Likert scale <br/ ><br>Change in severity of running nose from baseline <br/ ><br>Change in severity of throat irritation from baselineTimepoint: Baseline, Day 7