CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/06/089567 [Registered on: 25/06/2025] Trial Registered Prospectively

Last Modified On:

24/06/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Nutraceutical

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

A clincial study of a herbal supplementation in pain mangement.

Scientific Title of Study

A Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Herbal Supplementation (FBQP-AK-24) in Pain Management.

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
LCBS-AK-171 Version 1.0 dated 19 May 2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Harshith C S
Designation	Assistant Proessor
Affiliation	BGS Global Institute of Medical Sciences
Address	OPD No.03, Ground Floor, Department of General Medicine, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri Bangalore KARNATAKA 560060 India
Phone	8792516793
Fax
Email	drharshithcs.research@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 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, 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, Cochin 683561 Kerala, India

Primary Sponsor

Name	Akay Natural Ingredients Pvt. Ltd
Address	Malaidamthuruthu P. O Ernakulam, Cochin 683561 Kerala, India
Type of Sponsor	Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Harshith CS	BGS Global Institute of Medical Sciences	OPD No.03, Ground Floor, Department of General Medicine, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri Bangalore KARNATAKA	8792516793 drharshithcs.research@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, BGS Global Institute of Medical Sciences	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: R52\|\|Pain, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	FBQP-AK-24	Oral administration of single dose of FBQP-AK-24 once a day for 14 days
Comparator Agent	Placebo	Oral administration of single dose of Placebo once a day for 14 days

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1.Subjects with non-specific pain in the neck, hip, shoulder, or low back persisting for at least 6 weeks 2.Subjects with moderate pain intensity (NRS greater or equal to 4) at baseline 3.Subjects with functional impairment in any of the/more than one of the condition-speindices 4.Subjects who agree to maintain their usual dietary habits and level of exercise 5.Subjects willing to refrain from taking during the study 6.Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days 7.Females of childbearing age, agree to use approved birth control methods during the study, and have negative UPT at screening 8.Subjects willing and able to give informed consent and comply with the study procedures 9.Subjects willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study

ExclusionCriteria

Details

1.Subjects diagnosed with specific causes of pain 2.Subjects who have undergone recent surgery or trauma related to the affected area 3.Subjects who have used corticosteroids, narcotics, or other anti-inflammatory treatments within 2 weeks before enrolment 4.Subjects with a history of hypersensitivity to Boswellia or PEA 5.Subjects with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection 6.Subjects suffering from a metabolic disorder and or from severe chronic disease or from a disease found to be inconsistent with the conduct of the study by the investigator 7.Subjects with a psychiatric diagnosis including generalized anxiety or depression 8.Subjects with sleep disturbances and/or are taking sleep aid medication 9.Subjects with uncontrolled hypertension at screening.10.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications 11.Subjects with a history of drug and /or alcohol abuse at the time of enrolment 12.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period 13.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry 14.Any additional conditions that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Mean change in short term effect of FBQP-AK-2024 in pain intensity by Numeric Rating Scale (NRS)	Baseline, Day 7,Day 14

Secondary Outcome

Outcome	TimePoints
Mean change in functional capacity	Baseline, Day 7,Day 14
Mean change in quality of life	Baseline, Day 7,Day 14
Safety of FBQP-AK-2024	Baseline and Day 14

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
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

Phase 3/ Phase 4

Date of First Enrollment (India)

07/07/2025

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="3"
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 randomized, double-blind, placebo-controlled, parallel group, clinical interventional study. Adult healthy males or females, meeting all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent. After the informed consent process, demographic details , medical history and medications will be obtained. Subjects found eligible for study participation will be randomized into one of the treatment arms as per randomization schedule for a treatment period of 14 days. The study will be conducted in 4 visits. The efficacy assessments will include pain intensity, functional capacity, disability indices and quality of life.