To Evaluate The Efficacy And Safety Of HSGM-122104 Inchildren in (Healthy Human Volunteers)

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Inclusion CriteriaGroup I:

1.Healthy adult subjects of either sex aged between >= 18 years.

2.Subjects willing to refrain taking any other similar medication during the study period

3.Adult subjects who have not participated in any kind of clinical trial in the past 4 weeks.

4.Adult subjects who are willing to sign informed consent and follow the study procedure.

Group II, III and IV:

1.Target male and female subjects aged between >=12 to <=18 years in Group II, >=6 to <=12 years in Group III and >=3 to <=5 years in Group IV.

2.Subjects with mild to moderate respiratory infection with Score of 1 to 7 as per Investigator assessment scale in Appendix I will be included.

3.Parents/Guardians/Caregiver related to subjects, willing to give informed consent for his/her child to participate in the study.

4.Subjects aged 12-18 years of age willing to provide assent consent for his/her participation in the study along with parents/guardians/caregiver consent Subjects aged 7-12 years with oral consent along with parents/guardian/caregiver consent. Subject aged 3 to 7 years would require their parents/guardian/caregiver consent. (Refer protocol section 11.4, Informed Consent Process).

5.Pediatric Subjects willing to refrain taking any other similar medication during the study period

6.Pediatric subjects who have not participated in any kind clinical of trial in the past 4 weeks.

7.Parents/guardians/caregivers of the pediatric subjects willing to

sign informed consent/assent (as applicable) and follow the study procedure.

Exclusion Criteria

Exclusion Criteria1.Subjects with clinically significant serious cardiovascular, respiratory, cerebrovascular, hepatic, renal disease, endocrinal, congenital or any other disorder.

2.Subjects with severe respiratory infection as per Visual Analogue Scale (VAS) Score of > 7 in Investigator assessment scale Appendix

I will be excluded.

3.A known history or present condition of allergic response to the study products its components or ingredients in the investigational product.

4.Pre-existing systemic disease necessitating long-term medications.

5.Pregnant and lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and efficacy evaluation of HSGM-122104 in healthy and target volunteers by subjective questionnaire and investigator assessment and monitoring of adverse events <br/ ><br>volunteers by subjective questionnaire and investigator assessment and monitoring of adverse events <br/ ><br>Timepoint: Safety and efficacy evaluation of HSGM-122104 in healthy and target volunteers by subjective questionnaire and investigator assessment and monitoring of adverse events at EOS - 7 days <br/ ><br>volunteers by subjective questionnaire and investigator assessment and monitoring of adverse events at the end of 7 days <br/ ><br>

Secondary Outcome Measures