A clincial study of a herbal supplementation in pain mangement.

Phase 3

Not yet recruiting

• Conditions: Pain, unspecified,

• Registration Number: CTRI/2025/06/089567
• Lead Sponsor: Akay Natural Ingredients Pvt. Ltd

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 inthe study after signing a written informed consent. After the informed consentprocess, demographic details , medical history and medications will be obtained. Subjects found eligible for studyparticipation will be randomized into one of the treatment arms as perrandomization schedule for a treatment period of 14 days. The study will beconducted in 4 visits. The efficacy assessments will include painintensity, functional capacity,  disability indices and quality of life.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-24
• Study Start: 2025-07-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

BGS Global Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

BGS Global Institute of Medical Sciences

🇮🇳Bangalore, KARNATAKA, India

Dr Harshith CS

Principal investigator

8792516793

drharshithcs.research@gmail.com