Clinical study on Clensicap
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cohort A: <br/ ><br>Changes in clinical characteristics/symptoms of healthy kidney functions <br/ ><br> <br/ ><br>Cohort B: <br/ ><br> <br/ ><br>Changes in clinical characteristics/symptoms of healthy Liver functions <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Day 0, Day 15, Day 30, Day 45 and Day 60
- Secondary Outcome Measures
Name Time Method Cohort A: <br/ ><br>1.Change in eGFR and Renal function tests <br/ ><br>2.Changes in urine routine and microscopic examinations <br/ ><br>3.Changes in clinical symptoms (if any) <br/ ><br>4.Change in quality of life <br/ ><br>5.Global assessment of overall change <br/ ><br>6.Global assessment of tolerability of study product <br/ ><br>7.Adverse events and vitals. <br/ ><br>8.Safety laboratory investigations <br/ ><br>Cohort B: <br/ ><br>1.Changes Liver-Ultra Sonography, Liver functions, clinical symptoms related to skin (if any), energy, strength, stamina, weight and BMI, lipid profile levels <br/ ><br>2.Assessment of immunity through episodes, severity and duration of illness (infections or allergies) <br/ ><br>3.Change in quality of life. <br/ ><br>4.Global assessment of overall change <br/ ><br>5.Global assessment of tolerability of study product <br/ ><br>6.Adverse events and vitals. <br/ ><br>7.Safety laboratory investigations <br/ ><br>Timepoint: Day 0, Day 15, Day 30, Day 45 and Day 60