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.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Growth Metrics:
研究概览
简要总结
Brief Summary:
Childhood is a critical period for growth and development, where proper nutrition plays a vital role in a child’s health. However, many children face challenges such as poor appetite and undernutrition, leading to growth delays and an increased risk of infections. JB Bal Vita (Bal Poshak Rasayana) is a nutritional supplement designed to support children’s overall health, growth, and immune function. Based on traditional Ayurvedic principles, it includes ingredients that may enhance appetite, support digestion, and improve nutritional status. The product is aimed at children aged 3 to 6 years and is administered as a daily sachet. This study will evaluate the safety and efficacy of JB Bal Vita in improving health markers like growth, appetite, and nutrition in children with poor dietary intake and general weakness.
Purpose of the Study:
The purpose of this clinical study is to confirm the safety and effectiveness of JB Bal Vita in improving health markers such as growth, appetite, and overall nutritional status in children. By conducting this clinical trial, we aim to provide empirical evidence to support the product’s claims and ensure its adherence to modern clinical standards. This study will help establish JB Bal Vita as a safe and effective nutritional supplement, offering a natural solution for improving children’s health and addressing issues related to poor appetite and undernutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
- •Allergies: Any known allergy or hypersensitivity to the ingredients in JB Bal Vita (Bal PoshakRasayana).
- •Investigator’s Discretion: Children deemed unsuitable for the study by the investigatororphysician due to medical or behavioral
- •Medication Use: Children using medications or supplements that may interfere withthestudyproduct or affect growth and nutritional outcomes.
- •Lack of Consent: Children whose parents or legal guardians are unwilling or unable toprovideconsent or adhere to study requirements.
结局指标
主要结局
Growth Metrics:
时间窗: Day 0, Day 30, Day 60, Day 90
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.
时间窗: Day 0, Day 30, Day 60, Day 90
Appetite and Nutritional Status:
时间窗: Day 0, Day 30, Day 60, Day 90
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.
时间窗: Day 0, Day 30, Day 60, Day 90
次要结局
- Health Perception Questionnaire:(• Parental/Caregiver Perception: Collection of data from parents or caregivers on perceived)
研究者
Dr JamunaBA
RVS Ayurvedic Medical College Hospital and Research Centre