To evaluate the safety & Efficacy of Baby shampoo in babies of 0 months to 36 months

An Open label Single Arm Clinical Study to Evaluate the Safety & Efficacy of Baby shampoo in babies of 0 months to 36 months - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054326

Enrollment

Registered

2023-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

None listed

Interventions

Intervention1: Tear Free: Route of Administration: Topical Dosage: Quantity: pea nut sized Once a day Treatment period: 14 days Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects in the age group of 0 to 36 months (inclusive of both genders, equal number of male and female subjects). 2.Subjects in general good health as determined by the investigator. 3.Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up. 4.Subjects mother/legal representative, preferably mother willing to abide by and comply with the study protocol. 5.Subjects should not participate in any other study during participation in the current study.

Exclusion criteria

Exclusion criteria: 1. Babies with scalp / skin infection, history of hypersensitivity to study products which may interfere in the study. 2. A known history or present condition of allergies that may require medical attention. 3. Chronic illness which may influence the skin condition. 4. Subjects not willing to stop the use of other shampoos during study period

Design outcomes

Primary

Measure	Time frame
1. Evaluation of the mildness & gentleness on baby’s scalp on using Baby shampoo in babies of age group 0-36 months. 2. To evaluate the prevention of tangling of hair after the use of Baby Shampoo 3. No tears, all day long tangle free hair, smooth & shiny hair,cleanses gently & easy rinsability of the shampoo. 4. To evaluate the safety of Baby Shampoo in babies of age group 0-36 months by local intolerance assessed by the investigatorTimepoint: Day 1 Day 14	—

Measure

Time frame

1. Evaluation of the mildness & gentleness on baby’s scalp on using Baby shampoo in babies of age group 0-36 months. 2. To evaluate the prevention of tangling of hair after the use of Baby Shampoo 3. No tears, all day long tangle free hair, smooth & shiny hair,cleanses gently & easy rinsability of the shampoo. 4. To evaluate the safety of Baby Shampoo in babies of age group 0-36 months by local intolerance assessed by the investigatorTimepoint: Day 1 Day 14

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Secondary

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactMeena Dalal

TrialGuna Private Limited

psragavan@gmail.com8867125414

Outcome results