Health Condition 1: R05- Cough
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. 2. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy will be assessed by changes in cough severity from baseline to EOS using Cough VAS & Clinical Symptom Evaluation Questionnaire. Determination proportion of participants showing improvement within 3 days & those achieving complete relief. Time to onset of symptomatic relief after the first dose will be recorded. Changes in sputum characteristics from baseline to Day 3 and EOS will be evaluated using Sputum Evaluation Scale. Participant feedback on product experience and effectiveness. Timepoint: Day 1, Day 3 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints Incidence of AE during the Study period. Timepoint: Day 1, Day 3 and Day 14 | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed