CTRI/2023/07/054999尚未招募1 期
Clinical Study To Evaluate The Efficacy And Safety Of HSGM-122104 Inchildren - NI
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
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
- •Inclusion CriteriaGroup I:
- •1.Healthy adult subjects of either sex aged between >= 18 years.
- •2.Subjects willing to refrain taking any other similar medication during the study period
- •3.Adult subjects who have not participated in any kind of clinical trial in the past 4 weeks.
- •4.Adult subjects who are willing to sign informed consent and follow the study procedure.
- •Group II, III and IV:
- •1.Target male and female subjects aged between >=12 to <=18 years in Group II, >=6 to <=12 years in Group III and >=3 to <=5 years in Group IV.
- •2.Subjects with mild to moderate respiratory infection with Score of 1 to 7 as per Investigator assessment scale in Appendix I will be included.
- •3.Parents/Guardians/Caregiver related to subjects, willing to give informed consent for his/her child to participate in the study.
- •4.Subjects aged 12-18 years of age willing to provide assent consent for his/her participation in the study along with parents/guardians/caregiver consent Subjects aged 7-12 years with oral consent along with parents/guardian/caregiver consent. Subject aged 3 to 7 years would require their parents/guardian/caregiver consent. (Refer protocol section 11.4, Informed Consent Process).
- •5.Pediatric Subjects willing to refrain taking any other similar medication during the study period
- •6.Pediatric subjects who have not participated in any kind clinical of trial in the past 4 weeks.
- •7.Parents/guardians/caregivers of the pediatric subjects willing to
- •sign informed consent/assent (as applicable) and follow the study procedure.
排除标准
- •Exclusion Criteria1.Subjects with clinically significant serious cardiovascular, respiratory, cerebrovascular, hepatic, renal disease, endocrinal, congenital or any other disorder.
- •2.Subjects with severe respiratory infection as per Visual Analogue Scale (VAS) Score of > 7 in Investigator assessment scale Appendix
- •I will be excluded.
- •3.A known history or present condition of allergic response to the study products its components or ingredients in the investigational product.
- •4.Pre-existing systemic disease necessitating long-term medications.
- •5.Pregnant and lactating women.
研究者
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