CTRI/2022/08/044931尚未招募2 期
Randomized control trial to assess the efficacy and safety of Manna Go Grain Supplement to promote growth, immunity and wellbeing in children. - Nil
Southern Health Foods Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Children Aged 06 - 12 years inclusive (both gender)
- •2. Healthy individual with no signs and symptoms of malnutrition
- •3. Subjectââ?¬•s parents understand and is willing, able and likely to comply with all study procedures and restrictions.
排除标准
- •1. Subject has a known allergy or intolerance to the study product or ingredients or is on a special diet and cannot consume the study product
- •2. Subject has a current illness requiring hospitalization
- •3. Subject has a gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study
- •4. Subject is currently taking medication that could affect absorption/metabolism of study product or weight of the child. Exception: Topical/ocular steroids will be permitted during the study
- •5. Subject is diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma. (As per history and documentation in the medical records)
- •6. Subject has active tuberculosis, acute hepatitis B or C or HIV, malignancy (as per history and documentation in the medical records) as per discretion of investigation
- •7. Subject has a history of diabetes mellitus (as per history and documentation in the medical records)
- •8. Subject has been on antibiotic therapy within the last one month before start of the study (before study Day 1)
- •9. Subject has dysphagia, aspiration risk, and difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product. (As per history and documentation in the medical records)
- •10. Subject has a clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product) as diagnosed by the investigator.
研究者
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