Clinical Study to Assess the Safety and Benefits of JB Bal Vita for Improving Childrens Health.

An Open-Label, Single-Center, Single-Arm Clinical Study to Evaluate the Safety and Efficacy of JB BAL Vita (Bal Poshak Rasayana) In Enhancing Children s Health. - Nil

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080066

Enrollment

Registered

2025-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: R633- Feeding difficulties

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age: Children aged 3 to 6 years, inclusive. 2.Parental Consent: Consent must be provided by the mother or legal guardian through a signed informed consent form. The parent/guardian should agree to complete study activities and attend follow-up visits. 3.Willingness to Comply: The parent/legal guardian must agree to comply with study procedures, including scheduled visits and reporting on health metrics. 4.Nutritional Concerns: The child must exhibit poor appetite or inadequate nutritional intake, evidenced by symptoms such as weakness, emaciation, or refusal to eat. 5.Study Exclusivity: The child must not participate in any other clinical studies during their involvement in this study.

Exclusion criteria

Exclusion criteria: 1. Chronic Illness or Genetic Disorders: Children with significant chronic illnesses (e.g., heartdisease, chronic respiratory conditions) or genetic disorders that could impact growthordevelopment are excluded. 2. Allergies: Any known allergy or hypersensitivity to the ingredients in JB Bal Vita (Bal PoshakRasayana). 3. Investigator s Discretion: Children deemed unsuitable for the study by the investigatororphysician due to medical or behavioral 4. Medication Use: Children using medications or supplements that may interfere withthestudyproduct or affect growth and nutritional outcomes. 5. Lack of Consent: Children whose parents or legal guardians are unwilling or unable toprovideconsent or adhere to study requirements.

Design outcomes

Primary

Measure	Time frame
Growth Metrics: Changes in BMI from baseline to end of study to assess physical growth. Assessment of age-appropriate developmental milestones to evaluate physical and cognitive development. Appetite and Nutritional Status: Changes in appetite based on caregiver reports using structured questionnaires. Assessment of food intake through caregiver feedback on meal frequency and portion size. Overall nutritional status assessed through caregiver observations and anthropometric measures.Timepoint: Day 0, Day 30, Day 60, Day 90	—

Measure

Time frame

Growth Metrics: Changes in BMI from baseline to end of study to assess physical growth. Assessment of age-appropriate developmental milestones to evaluate physical and cognitive development. Appetite and Nutritional Status: Changes in appetite based on caregiver reports using structured questionnaires. Assessment of food intake through caregiver feedback on meal frequency and portion size. Overall nutritional status assessed through caregiver observations and anthropometric measures.Timepoint: Day 0, Day 30, Day 60, Day 90

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Secondary

Measure	Time frame
Health Perception Questionnaire: Parental/Caregiver Perception: Collection of data from parents or caregivers on perceived health improvements, such as energy levels, immune health (reduction in frequency of minor illnesses), & general well-being of the child. Safety Endpoints: Adverse Events (AEs): Monitoring & recording any adverse events throughout the study to ensure the safety profile of JB Bal Vita in children aged 3 to 6 years. Tolerability: Assessment of any side effects or discomfort reported by parents or caregivers to evaluate overall tolerability. Timepoint: Day 0, Day 30, Day 60, Day 90	—

Measure

Time frame

Health Perception Questionnaire: Parental/Caregiver Perception: Collection of data from parents or caregivers on perceived health improvements, such as energy levels, immune health (reduction in frequency of minor illnesses), & general well-being of the child. Safety Endpoints: Adverse Events (AEs): Monitoring & recording any adverse events throughout the study to ensure the safety profile of JB Bal Vita in children aged 3 to 6 years. Tolerability: Assessment of any side effects or discomfort reported by parents or caregivers to evaluate overall tolerability. Timepoint: Day 0, Day 30, Day 60, Day 90

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Countries

India

Contacts

Public ContactMs Mamatha B Gokavi

Samahitha Research Solutions

satyalm@samahitha.com9739001749

Outcome results