跳至主要内容
临床试验/CTRI/2019/11/021993
CTRI/2019/11/021993招募中1 期

Randomized control trial to assess the efficacy and safety of NRL/2019/5PNK withmicronutrient fortification to promote growth, health and wellbeing in children. - NI

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试验速览

阶段
1 期
状态
招募中
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

  • Children Aged 06 - 11 years inclusive (both gender)
  • Consent: Understanding of the study and willingness to participate as evidenced by subjectâ??s
  • parents and/or legal guardianâ??s voluntary written informed consent.
  • Compliance: Understands and is willing, able and likely to comply with all study procedures
  • and restrictions.

排除标准

  • 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
  • Subject has a current illness requiring hospitalization
  • Subject has a gastrointestinal infection and/or acute diarrhea at the time of inclusion in the
  • 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
  • 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)
  • 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
  • Subject has a history of diabetes mellitus (as per history and documentation in the medical
  • Subject has been on antibiotic therapy within the last one month before start of the study
  • (before study Day 1)
  • 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)
  • 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

发起方
etsurf Communications Pvt Ltd

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