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临床试验/CTRI/2022/02/040414
CTRI/2022/02/040414
尚未招募
1 期

Safety, tolerability and sensory evaluation of Diakof Linctus in healthy volunteers

Himalaya Wellness Company0 个研究点目标入组 0 人待定
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概览

阶段
1 期
干预措施
未指定
疾病 / 适应症
未指定
发起方
Himalaya Wellness Company
状态
尚未招募
最后更新
4年前
概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
4年前
研究类型
Interventional

研究者

入排标准

入选标准

  • •Adult population:
  • •1\.Healthy adult subjects of either sex aged between \>\= 18 to \<\= 50 years.
  • •2\.Subjects willing to refrain taking any other similar medication during the study period
  • •3\.Adult subjects who have not participated in this kind of trial in the past 4 weeks
  • •4\.Adult subjects willing to sign informed consent and follow the study procedure.
  • •Pediatric Population:
  • •1\.Healthy male and female pediatric subjects aged between \>\=2 years to \<\=12 years.
  • •2\.Parents/Guardians/Caregiver related to pediatric subjects \< 7 years willing to give informed consent for his/her child to participate in the study.
  • •3\.Pediatric subjects aged \> 7 years of age willing to provide oral consent for his/her participation in the study along with parents/guardians/caregiver consent
  • •4\.Pediatric Subjects willing to refrain taking any other similar medication during the study period

排除标准

  • •1\.Subjects with clinically significant serious cardiovascular, respiratory,
  • •cerebrovascular, hepatic, renal disease, endocrinal, congenital or any other disorder.
  • •2\.A known history or present condition of allergic response to the study products its components or ingredients in the investigational product.
  • •3\.Pre\-existing systemic disease necessitating long\-term medications.
  • •4\.Subjects who refused to sign informed consent.
  • •5\.Pregnant and lactating women.

结局指标

主要结局

未指定

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