CTRI/2022/10/046223已完成2 期
An open labelled, multi-center, non-comparative, interventional, prospectiveclinical study to evaluate efficacy and safety of Clenscicap in healthy participants.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
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.Healthy male and females
- •2.Ready to provide written consent and follow all the study procedure.
- •1.Healthy male and females with mild to moderate digestive complaints
- •2.Ready to provide written consent and follow all the study procedure
排除标准
- •Cohort A:-
- •1.Subjects with known tuberculosis, Hepatitis B and C, HIV, ischemic heart disease, cancer, Kidney stone, Urinary tract infection, kidney failure, chronic liver diseases.
- •2. Subjects with any other investigational product within 1 month prior to randomization.
- •3.Subjects with diabetes mellitus and hypertension taking regular medications
- •4.Pregnant and lactating women
- •5.Subjects with significant abnormal laboratory parameters
- •6.Known hypersensitivity to any of the ingredients of CLENSCICAP
- •7.Other conditions, which in the opinion of the investigators, make subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.
- •Cohort B:-
- •1.Subjects with known tuberculosis, hepatitis B and C, HIV, ischemic heart disease, cancer, kidney failure, chronic liver diseases,
- •2.Subjects having jaundice or any other symptom of active hepatitis
- •3.Subjects with any other investigational product within 1 month prior to randomization.
- •4.Subjects with diabetes mellitus and hypertension taking regular medications
- •5.Pregnant and lactating women
- •6.Subjects with any significant abnormal laboratory parameters
- •7.Known hypersensitivity to any of the ingredients of Clensicap Capsule.
- •8.Other conditions, which in the opinion of the investigators, make subject unsuitable for enrolment or could interfere with his/her participation in, and completion of study.
研究者
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