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Clinical Trials/CTRI/2022/02/040337
CTRI/2022/02/040337
Not yet recruiting
Phase 1

Safety, tolerability and sensory evaluation of Cystone Syrup in healthy volunteers

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
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

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

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Adult population:
  • •1\.Healthy adult subjects of either sex aged between \>\= 18 to \<\= 50 years.
  • •2\.Subjects willing to refrain taking any other similar medication during the study period
  • •3\.Adult subjects who have not participated in this kind of trial in the past 4 weeks
  • •4\.Adult subjects willing to sign informed consent and follow the study procedure.
  • •Pediatric Population:
  • •1\.Healthy male and female pediatric subjects aged between \>\=2 years to \<\=12 years.
  • •2\.Parents/Guardians/Caregiver related to pediatric subjects \< 7 years willing to give informed consent for his/her child to participate in the study.
  • •3\.Pediatric subjects aged \> 7 years of age willing to provide oral consent for his/her participation in the study along with parents/guardians/caregiver consent (Refer protocol section 11\.4, Informed Consent Process)
  • •4\.Pediatric Subjects willing to refrain taking any other similar medication during the study period

Exclusion Criteria

  • •1\.Subjects with clinically significant serious cardiovascular, respiratory,
  • •cerebrovascular, hepatic, renal disease, endocrinal, congenital or any other disorder.
  • •2\.A known history or present condition of allergic response to the study products its components or ingredients in the investigational product.
  • •3\.Pre\-existing systemic disease necessitating long\-term medications.
  • •4\.Subjects who refused to sign informed consent.
  • •5\.Pregnant and lactating women.

Outcomes

Primary Outcomes

Not specified

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