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Evaluating the safety of Liv.52 DS SF Syrup in healthy volunteers

Safety, tolerability and sensory evaluation of Liv.52 DS SF Syrup in healthy volunteers

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046468
Enrollment
24
Registered
2022-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Himalaya Wellness Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 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 5.Pediatric subjects who have not participated in this kind of trial in the past 4 weeks. 6.Parents/ Guardians/ Caregivers of the pediatric subjects willing to sign informed consent/assent (as applicable) and follow the study procedure.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Occurrence of any adverse or serious adverse events during the study period.Timepoint: 7 days

Secondary

MeasureTime frame
Overall compliance to the study medicationTimepoint: 7 days

Countries

India

Contacts

Public ContactKavitha Rangaiah

Himalaya Wellness Company

dr.sooryanarayan.h@himalayawellness.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026