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
- 2/3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cohort A:
研究概览
简要总结
It is an open labelled, multi-center,non-comparative, interventional, prospective clinical study to evaluateefficacy and safety of Clenscicap in healthy participants. The study will becarried out at 2 centers in India. Subjects will be asked to take Clensicap ina dose of 1 capsule twice daily orally after meals with water for 2 months.
Cohort A:
Primary objective of the study will be to assess changes in clinicalcharacteristics/symptoms of healthy kidney functions. Secondary objectives ofthe study will be to assess changes in eGFR and Renal function tests, urineroutine and microscopic examinations, clinical symptoms (if any), quality oflife assessed on WHO QOL BREF, global assessment of overall change byinvestigator and subject, global assessment of tolerability of study product byinvestigator and subject, adverse events and vitals, and pre and post productconsumption safety laboratory investigations on Day 0, Day 15, Day 30, Day 45and Day 60
Cohort B:
Primary objective of the study will beto assess changes in clinical characteristics/symptoms of healthy Liverfunctions. Secondary objectives of the study will be to assess changes in Liver-UltraSonography, Liver functions, clinical symptoms (if any), clinical symptomsrelated to skin (if any), energy, strength, stamina, immunity through episodes,severity and duration of illness (infections or allergies), quality of lifeassessed on WHO QOL BREF, lipid profile levels, weight and BMI, globalassessment of overall change by investigator and subject, global assessment oftolerability of study product by investigator and subject, adverse events andvitals, and pre and post product consumption safety laboratory investigations onDay 0, Day 15, Day 30, Day 45 and Day 60
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Cohort A: 1.Healthy male and females 2.Ready to provide written consent and follow all the study procedure.
- •Cohort B: 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.
- •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.
结局指标
主要结局
Cohort A:
时间窗: Day 0, Day 15, Day 30, Day 45 and Day 60
Changes in clinical characteristics/symptoms of healthy kidney functions
时间窗: Day 0, Day 15, Day 30, Day 45 and Day 60
Cohort B:
时间窗: Day 0, Day 15, Day 30, Day 45 and Day 60
Changes in clinical characteristics/symptoms of healthy Liver functions
时间窗: Day 0, Day 15, Day 30, Day 45 and Day 60
次要结局
- Cohort A:(1.Change in eGFR and Renal function tests)