CTRI/2022/04/041811
尚未招募
1 期
Safety, tolerability and sensory evaluation of Septilin Syrup in Healthy Volunteers
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
简要总结
暂无简介。
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 (Refer protocol section 11\.4, Informed Consent Process)
- •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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