Evaluation of Renalka SF syrup in healthy people

Phase 1

• Registration Number: CTRI/2022/03/041236
• Lead Sponsor: Himalaya Wellness Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 < 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

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of any adverse or serious adverse events during the study period and any change in the lab parameters like CBC & liver function testTimepoint: 7 days

Secondary Outcome Measures

Name	Time	Method
Overall compliance of the subject to the study medicationTimepoint: 7 days