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Clinical Trials/CTRI/2023/07/054999
CTRI/2023/07/054999
Not yet recruiting
Phase 1

Clinical Study To Evaluate The Efficacy And Safety Of HSGM-122104 Inchildren - NI

Himalaya Wellness Company0 sites0 target enrollmentTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Himalaya Wellness Company
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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).

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.

Outcomes

Primary Outcomes

Not specified

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