| CTRI Number |
CTRI/2025/02/081268 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical study on bioavailability of FBQP-AK-24 in Healthy Human Volunteers. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, 3-Way Crossover, 3 Sequence Study to Assess the Bioavailability of Formulated Boswellia-PEA (FBQP-AK-24) in Comparison with Normal Unformulated Boswellia-PEA (UFBQP-AK-24) Supplementation in Healthy Volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-BA-145, Version 1.0 dated 18 Jul 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.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
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
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, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Akay Natural Ingredients Pvt. Ltd,Malaidamthuruthu P.O Ernakulam, Kerala 683561, India |
|
|
Primary Sponsor
|
| Name |
Akay Natural Ingredients Pvt. Ltd |
| Address |
Malaidamthuruthu P.O Ernakulam, Kerala 683561, 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 Siju C Thomas |
Akay Natural Ingredients Pvt. Ltd |
Department of Research and Development,Room No:2, 1st Floor, R&D Building, Malaidamthuruthu P. O.
Ernakulam
KERALA |
944742049
drsijuthomas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Balaji Independent 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 |
| Intervention |
FBQP-AK-24 |
250 mg capsule,single-dose oral administration of FBQP-AK-24 for a duration of one day. |
| Intervention |
FBQP-AK-24 |
500 mg capsule,single-dose oral administration of FBQP-AK-24 for a duration of one day. |
| Comparator Agent |
UFBQP-AK-24 |
500 mg capsule,single-dose oral administration of UFBQP-AK-24 for a duration of one day. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 2.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study 3. Subjects having body mass index (BMI) in between 19-26 kg/m2.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have consumed either Boswellia or PEA containing food/supplement 7 days prior to screening 2.Pregnant or lactating women 3.Subjects with known hypersensitivity to the investigational products 4.Subjects who have participated in any clinical trial in the past 1 month 5.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study 6. 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 |
| To estimate the concentrations of formulated Boswellia-PEA (FBQP-AK-24) in comparison with normal unformulated Boswellia-PEA (UFBQP-AK-24) supplementation |
Baseline, Day 9, Day 17 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetics parameters of FBQP-AK-24 in comparison with UFBQP-AK-24 supplementation |
Baseline, Day 9, Day 17 |
| Safety and tolerability of FBQP-AK-24 in comparison with UFBQP-AK-24 supplementation. |
Baseline, Day 9, Day 17 |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
10/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a comparative,
randomized, 3-way crossover, 3-sequence study to compare the bioavailability of
formulated Boswellia-PEA
(FBQP-AK-24) in comparison with normal unformulated Boswellia-PEA (UFBQP-AK-24) supplementation.
A group of 15 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 3-treatment sequences on Visit 2, followed by treatment
sequences 2 and 3 on subsequent visits (Visit 3 and 4). There will be 2 washout periods in betweeen the 3 dosing days. |