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A clinical study to check the Safety, Tolerability and Sensory Evaluation of Baby foods ââ?¬â?? wheat variant

Safety, Tolerability and Sensory Evaluation of Baby foods ââ?¬â?? wheat in Healthy Volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044832
Enrollment
144
Registered
2022-08-23
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 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 babies Population: 1. Healthy male and female subjects aged between 6months to 12 years depends on the groups. 2. Parents/Guardians/Caregiver related to subjects 3. 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. Subjects not using similar products during the study period. 5. Subjects willing to refrain taking any other similar products during the study period 6. Subjects who have not participated in this kind of trial in the past 4 weeks. 7. Parents/ Guardians/ Caregivers of the 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
1. Safety, Tolerability, and sensory evaluation of Baby foods - wheat variant in study population 2. The study evaluate the incidence of adverse events in study population. the study is conducted in 3 groups, Group A: 18-50years, Group B: 2-12 years and Group C: 6months to 24 months babiesTimepoint: Baseline/ Day 1 Day 7 (end of week 1)—

Secondary

MeasureTime frame
1. Overall compliance to the test productTimepoint: Baseline Day 1 Day 7—

Countries

India

Contacts

Public ContactDr Soorya Narayan H

Himalaya wellness company

dr.swathi.b@himalayawellness.com9838969888

Outcome results

None listed

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