A multicenter, safety, effectiveness and in-use tolerability study of test formulation HBCR-011805 on children from 3 months to 5 years with acute cold symptoms such as (nasal congestion, blockage, itchy nose, sneezing, runny nose)
- Conditions
- Health Condition 1: J00- Acute nasopharyngitis [common cold]
- Registration Number
- CTRI/2022/07/043669
- Lead Sponsor
- Himalaya Wellness Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 101
1)� � � Age: 3 months to 5 years (both inclusive) at the time of consent.
2)� � � � Subject with acute cold symptoms having signs and symptoms as listed below but not limited to this
-� � � � Nasal congestion/blockage,
-� � � � Itchy nose,
-� � � � Sneezing,
-� � � � Runny nose.
3)� � � � 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)� � � � Subject should not participate in any other clinical study during participation in the current study.
7)� � � � Subject with normal vital parameters
-� � � � Respiratory rate in resting condition should be less than 40/minutes
-� � � � Temperature: Normal forehead temperature less than 100 �°F( 37.5 �°C)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>- 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. <br/ ><br>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 Outcome Measures
Name Time Method