A clinical study to asses the Safety, Tolerability and In-use efficacy study of test product

Phase 1

• Registration Number: CTRI/2022/06/043185
• Lead Sponsor: Himalaya wellness company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 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 45 years.

2.Subjects willing to refrain taking any other similar products 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.

Children and target Population:

1.Healthy male and female subjects aged between 3 months to 12 years depends on the stages.

2.Subjects with nasal congestion, stuffy nose, discomfort in breathing due to nasal congestion.

3.Parents/Guardians/Caregiver related to subjects < 7 years willing to give informed consent for his/her child to participate in the study.

4.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)

5.Subjects not using similar products during the study period.

6.Subjects willing to refrain taking any other similar products during the study period

7.Subjects who have not participated in this kind of trial in the past 4 weeks.

8.Parents/ Guardians/ Caregivers of the 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