Clinical study on Clensicap

Phase 2/3

Completed

Conditions: COHORT A: Healthy subjects COHORT B: Healthy subjects with mild to moderate digestive complaints

Registration Number: CTRI/2022/10/046223

Lead Sponsor: Transformative Learning Solutions Private Limited

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohort A:	Day 0, Day 15, Day 30, Day 45 and Day 60
Changes in clinical characteristics/symptoms of healthy kidney functions	Day 0, Day 15, Day 30, Day 45 and Day 60
Cohort B:	Day 0, Day 15, Day 30, Day 45 and Day 60
Changes in clinical characteristics/symptoms of healthy Liver functions	Day 0, Day 15, Day 30, Day 45 and Day 60

Secondary Outcome Measures

Name	Time	Method
Cohort A:	1.Change in eGFR and Renal function tests

Trial Locations

Locations (2): Ayurved Seva Sanghâ€™s Ayurved Mahavidyalaya
🇮🇳
Nashik, MAHARASHTRA, India
KVTR Ayurved College and Hospital Ayurved College and Hospital
🇮🇳
Dhule, MAHARASHTRA, India
Ayurved Seva Sanghâ€™s Ayurved Mahavidyalaya
🇮🇳Nashik, MAHARASHTRA, India
Dr Shishir Pande
Principal investigator
9420830818
shishir.nsk@gmail.com