Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
Intervention1: HBCR-011805 is an easy-to-apply, non-greasy gentle and effective soothing balm specially formulated with a blend of natural oils of Eucalyptus, Frankincense, Rosemary and Ocimum for bab
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1)Ã? Ã? Ã? Age: 3 months to 5 years (both inclusive) at the time of consent. 2)Ã? Ã? Ã? Ã? Subject with acute cold symptoms having signs and symptoms as listed below but not limited to this -Ã? Ã? Ã? Ã? Nasal congestion/blockage, -Ã? Ã? Ã? Ã? Itchy nose, -Ã? Ã? Ã? Ã? Sneezing, -Ã? Ã? Ã? Ã? Runny nose. 3)Ã? Ã? Ã? Ã? Overall Good health of the child subject is determined by medical examination and history evaluated by Investigator. 4)Ã? Ã? Ã? Ã? Subjectââ?¬•s mother/legal guardian, preferably willing to give a voluntary written informed consent i.e. parental informed consent and agree to complete study activities and come for regular follow up with the subject. 5)Ã? Ã? Ã? Ã? Subjectââ?¬•s mother/legal guardian for their child is preferably willing to abide by and comply with the study protocol. 6)Ã? Ã? Ã? Ã? Subject should not participate in any other clinical study during participation in the current study. 7)Ã? Ã? Ã? Ã? Subject with normal vital parameters -Ã? Ã? Ã? Ã? Respiratory rate in resting condition should be less than 40/minutes -Ã? Ã? Ã? Ã? Temperature: Normal forehead temperature less than 100 Ã?°F( 37.5 Ã?°C)
Exclusion criteria
Exclusion criteria: 1)� Subjects with a known history or present condition of an allergic response to any other vapour rub, balm, or its components or ingredients as in the test product. 2)� Subjects requiring medical treatment for the indicated symptoms 3)� Subjects requiring incubators/ventilators or C-PAP. 4)� Subjects having a history or present condition of upper respiratory diseases, or any allergies. 5)� Subjects having a history or present condition of COPD. 6)� Subjects having a history | or present condition of any pre-existing systemic disease necessitating long term medications and other dermatological problems. 7) Subjects who have participated in a similar clinical investigation in the past four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the effect of the HBCR-011805 in terms of relief in acute cold clinical symptoms of nasal congestion/blockage, itchy nose, sneezing, and runny nose by the paediatrician or paediatrician trained evaluator - Reoccurrence of clinical symptoms will be considered when subjects starts showing similar clinical symptoms again, it will be derived from the subject diary and/or telephonic | in-person evaluation. Timepoint: Before product application and at clinic at 10 mins, 30 mins, 1 hour, 2 hours and 3 hours post-application at clinic on Day 1, Day 2 (telephonic follow-up by study staff) and Day 7 if cold symptoms continue | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the childââ?¬â?¢s skin will be assessed by local intolerance evaluation [erythema, dryness, oedema, urticaria, pruritus, allergic reactions and any other of HBCR-011805 and incidence of adverse event: Either self-reported by mother/guardian of children or assessed by the Pediatrician or Study PhysicinTimepoint: on Day 1, 7 and throughout the study period;2. To assess the effect of the HBCR-011805 in terms of improvement in acute cold clinical symptoms at a clinic on Day 1 using VAS (Visual Analog Score) upon the subjectââ?¬â?¢s response received from Mother/legal guardianTimepoint: Baseline before application and at 1 min, 2 mins, 5 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, 3 hours post-application and in-between the mentioned time points at a clinic on Day 1;3. To assess the effect of the HBCR-011805 in terms of local intolerance mildness, gentleness, non-irritability, skin erythema/redness, dryness, rashes, itching by the pediatrician or pediatrician trained evaluator scoringTimepoint: Before application and at 3 hours post-application on Day 1, and on Day 7;4. To assess the subjectââ?¬â?¢s and motherââ?¬â?¢s experience for: - Mild and Gentle on childââ?¬â?¢s skin - Calms, soothes and relaxes - Starts easing discomfort from the 1st use - Relief from nasal discomfort from the 1st use - Helps promote easy breathing - Helps sleep better - For restful and peaceful all-night sleep - Easeââ?¬â?¢s discomfort associated with nasal congestion or stuffy nose - Non-greasy/ Non sticky/ Non-Staining - Likeness of calming and soothing aroma feeling on effectiveness - Overall satisfaction of the product Using ââ?¬Ë?Subjective Product Perception Assessmentââ?¬â?¢ for subject after HBCR-011805 useTimepoint: on Day 1, 2 & 7 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed