| CTRI Number |
CTRI/2022/02/039882 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
30/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative Bioavailability study in Healthy Subjects |
|
Scientific Title of Study
|
A randomized, single-dose, double-blind, active-control comparative, 2-way crossover, 2 sequence study to assess the bioavailability of curcuminoids formulations, Vicumin in comparison with Acumin supplementation in healthy volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayashree S Seeri |
| Designation |
Principal Investigator |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of Community Medicine,BGS Global Institute of Medical Sciences #67, BGS health and Education city, Uttarahalli road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9482164779 |
| Fax |
|
| Email |
drjayashree.ct@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs Pvt Ltd,Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Pvt Ltd |
| Address |
Vidya Building,N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayashree S Seeri |
BGS Global Institute of Medical sciences |
Department of community medicine, 2nd Floor, #67, BGS health and Education city, Uttarahalli road, Kengeri
Bangalore
KARNATAKA |
9482164779
drjayashree.ct@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BGS Global Institute of Medical Scineces Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Normal Hematological and Biochemical Parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Acumin |
Single Day Oral application of single dose of 500mg Acumin |
| Intervention |
Vicumin |
Single Day Oral application of single dose of 500mg Vicumin |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who are willing to give their written informed consent and comply with the protocol requirements.
2.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
3.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have consumed curcumin (turmeric) containing food 2 days prior to screening
2.Subjects having symptoms of viral infection, including COVID-19 infection
3.Pregnant or lactating women.
4.Subjects with known hypersensitivity to the investigational products.
5.Subjects who have participated in any clinical trial in the past 1 month.
6.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.
7.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the bioavailability of curcuminoids formulation, Vicumin in comparison with Acumin |
Day 1(Period 1), Day 11(Period 2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of Curcuminioids formulations Vicumin and Acumin |
Day 1(Period 1), Day 11(Period 2) |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None Yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, single-dose, double-blind,
active-control comparative, 2-way crossover, 2-sequence study to compare
the of curcuminoids formulations,
Vicumin in
comparison with Acumin supplementation in healthy volunteers. A group of 16 healthy
volunteers willing to give a written informed consent will be screened on Visit
1 to confirm the eligibility. Subjects fulfilling the eligibility criteria will
be randomized into 1 of 2-treatment sequences on Visit 2. On the morning of Day
1, in each period, subjects will receive a single oral dose of their assigned
formulation as per randomization scheme. A total of 8 blood samples will be
collected in each of the two study periods. 10 days of
washout period will be maintained between the study periods. |