| CTRI Number |
CTRI/2022/10/046223 [Registered on: 06/10/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Clensicap |
|
Scientific Title of Study
|
An open labelled, multi-center, non-comparative, interventional, prospective
clinical study to evaluate efficacy and safety of Clenscicap in healthy participants.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLENSCICAP/LIVKIDETOX/TLS/2022/1, Version 1.0, 11th AUG 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendra B Mundhe |
| Designation |
Assistant Professor |
| Affiliation |
KVTR Ayurvedic College and Hospital Boradi |
| Address |
Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR Ayurvedic College and Hospital, Boradi, Tal. Shirpur, Dist Dhule
Dhule
MAHARASHTRA
425428
India |
| Phone |
09850378206 |
| Fax |
|
| Email |
drnbmundhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Transformative Learning Solutions Private Limited
1 G, Bharat Nagar, New Friends Colony,
New Delhi-110025
|
|
|
Primary Sponsor
|
| Name |
Transformative Learning Solutions Private Limited |
| Address |
1 G, Bharat Nagar, New Friends Colony,
New Delhi-110025
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shishir Pande |
Ayurved Seva Sangh’s Ayurved Mahavidyalaya |
Ayurved Sanshodhan Vibhag, OPD No 7A, Ground Floor, Ayurved Seva Sangh’s Ayurved Mahavidyalaya, Ganeshwadi, Panchvati, Nashik, Maharashtra – 422003
Nashik
MAHARASHTRA |
9420830818
shishir.nsk@gmail.com |
| Dr Narendrakumar B Mundhe |
KVTR Ayurved College and Hospital Ayurved College and Hospital |
Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR Ayurved College and Hospital Boradi, Tal. Shirpur, Dist Dhule, 425428
Dhule
MAHARASHTRA |
9850378206
drnbmundhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurved Seva Sanghs Ayurved Mahavidyalaya, Nashik |
Submittted/Under Review |
| Institutional Ethics Committee, KVTR Ayurved College and Hospital, Boradi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COHORT A: Healthy subjects COHORT B: Healthy subjects with mild to moderate digestive complaints |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cohort A:
Changes in clinical characteristics/symptoms of healthy kidney functions
Cohort B:
Changes in clinical characteristics/symptoms of healthy Liver functions
|
Day 0, Day 15, Day 30, Day 45 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
Day 0, Day 15, Day 30, Day 45 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open labelled, multi-center,
non-comparative, interventional, prospective clinical study to evaluate
efficacy and safety of Clenscicap in healthy participants. The study will be
carried out at 2 centers in India. Subjects will be asked to take Clensicap in
a 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 clinical
characteristics/symptoms of healthy kidney functions. Secondary objectives of
the study will be to assess changes in eGFR and Renal function tests, urine
routine and microscopic examinations, clinical symptoms (if any), quality of
life assessed on WHO QOL BREF, global assessment of overall change by
investigator and subject, global assessment of tolerability of study product by
investigator and subject, adverse events and vitals, and pre and post product
consumption safety laboratory investigations on Day 0, Day 15, Day 30, Day 45
and Day 60
Cohort B:
Primary objective of the study will be
to assess changes in clinical characteristics/symptoms of healthy Liver
functions. Secondary objectives of the study will be to assess changes in Liver-Ultra
Sonography, Liver functions, clinical symptoms (if any), clinical symptoms
related to skin (if any), energy, strength, stamina, immunity through episodes,
severity and duration of illness (infections or allergies), quality of life
assessed on WHO QOL BREF, lipid profile levels, weight and BMI, global
assessment of overall change by investigator and subject, global assessment of
tolerability of study product by investigator and subject, adverse events and
vitals, and pre and post product consumption safety laboratory investigations on
Day 0, Day 15, Day 30, Day 45 and Day 60 |