| CTRI Number |
CTRI/2022/10/046222 [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 OptimaLiv Capsule |
|
Scientific Title of Study
|
An open labelled, multi-center, non-comparative, interventional, prospective
clinical study to evaluate efficacy and safety of OptimaLiv Capsule in healthy participants.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OPTIMALIV/LIVDETOX/TLS/2022/1, Version 1.0, 10th AUG 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chetan Neelnath Mhaske |
| Designation |
Director |
| Affiliation |
Dr. Mhaske Hospital and Research Centre |
| Address |
Dr. Mhaske Hospital and Research Centre, Department of Surgery, OPD no. 1, ground floor, Jiyaji Mention
Building, next to Old Post Office, Gadital, Hadapsar,
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9923010890 |
| Fax |
|
| Email |
seemhaske@yahoo.co.in |
|
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 D G Dipankar |
Dr. D.Y. Patil College of Ayurved and Research Center |
Department of Kayachkitsa, Ground floor, OPD No 5, Dr. D.Y. Patil College of Ayurved and Research Center, Pimpri, Pune
Pune
MAHARASHTRA |
9156473172
snehadipayurved@gmail.com |
| Dr Chetan Neelnath Mhaske |
Dr. Mhaske Hospital and Research Centre |
Department of Surgery,
OPD no. 1, ground floor, Jiyaji Mention
Building, Next to Old Post Office, Gadital, Hadapsar,
Pune- 411028
Email -
Contact. No.-
Pune
MAHARASHTRA |
9923010890
seemhaske@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Dr. Mhaske Hospital and Research Centre, Pune |
Approved |
| Institutional Ethics Committee, Dr. D.Y. Patil College of Ayurved and Research Center, Pimpri, Pune |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mild to moderate digestive complaints |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
OptimaLIV capsule |
Subjects will be asked to take OptimaLiv in a dose of 1 capsule twice daily orally after meals with water for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy males and females with mild to moderate digestive complaints (Healthy individuals will be defined as those who are not taking any medications and do not require continuous medical care and monitoring)
2. Ready to provide written consent and follow all the study procedure
|
|
| ExclusionCriteria |
| Details |
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 OptimaLIV Capsules
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 the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in clinical characteristics/symptoms of healthy Liver functions through assessment of digestion related symptoms |
Day 0, Day 15, Day 30, Day 45 and Day 60. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in Liver-Ultra Sonography
2. Change in Liver functions
3. Changes in clinical symptoms (if any)
4. Changes in clinical symptoms related to skin (if any)
5. Changes in energy, strength, stamina
6. Assessment of immunity through episodes, severity and duration of illness (infections or allergies)
7. Change in quality of life assessed on WHO QOL BREF
8. Change in lipid profile levels
9. Change in Weight and BMI
10. Global assessment of overall change by investigator and subject
11. Global assessment of tolerability of study product by assessing ADRs, vitals and clinical symptoms
12. Assessment of adverse events
13. Changes in pre and post product consumption safety laboratory investigations
|
Day 0, Day 15, Day 30, Day 45 and Day 60. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 OptimaLiv
Capsule in healthy participants. The study will be carried out at two centers in
India. Subjects will be asked to take OptimaLiv in a dose of 1 capsule twice
daily orally after meals with water for 2 months. The primary objective of the
study will be to assess changes in clinical characteristics/symptoms of healthy
Liver functions through assessment of digestion related symptoms. The secondary
objectives of the study will be to assess changes in Liver-Ultra Sonography, changes
in liver functions, changes in clinical symptoms (if any), changes in clinical
symptoms related to skin (if any), changes in energy, strength, stamina, assessment
of immunity through episodes, severity and duration of illness (infections or
allergies), changes in quality of life assessed on WHO QOL BREF, changes in
lipid profile levels, changes in Weight and BMI, global assessment of overall
change by investigator and subject, global assessment of tolerability of study
product by assessing ADRs, vitals and clinical symptoms, assessment of adverse
events and changes in pre and post product consumption safety laboratory
investigations on Day 0, Day 15, Day 30, Day 45 and Day 60. |