None listed
Conditions
Interventions
Intervention1: Clenscicap capsule: Cohort A and B:
Subjects will be asked to take Clensicap in a dose of 1 capsule twice daily orally after meals with water for 2 months
Control Intervention1: NIL: N
Sponsors
Transformative Learning Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort A: Changes in clinical characteristics/symptoms of healthy kidney functions Cohort B: Changes in clinical characteristics/symptoms of healthy Liver functions Timepoint: Day 0, Day 15, Day 30, Day 45 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort A: 1. Change in eGFR and Renal function tests 2. Changes in urine routine and microscopic examinations 3. Changes in clinical symptoms (if any) 4. Change in quality of life 5. Global assessment of overall change 6. Global assessment of tolerability of study product 7. Adverse events and vitals. 8. Safety laboratory investigations Cohort B: 1. Changes Liver-Ultra Sonography, Liver functions, clinical symptoms related to skin (if any), energy, strength, stamina, weight and BMI, lipid profile levels 2. Assessment of immunity through episodes, severity and duration of illness (infections or allergies) 3. Change in quality of life. 4. Global assessment of overall change 5. Global assessment of tolerability of study product 6. Adverse events and vitals. 7. Safety laboratory investigations Timepoint: Day 0, Day 15, Day 30, Day 45 and Day 60 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed