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

Akay Natural Ingredients Pvt. Ltd1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2025年7月7日最近更新: 2025年6月24日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方
入组人数: 120
试验地点: 1
主要终点: Mean change in short term effect of FBQP-AK-2024 in pain intensity by Numeric Rating Scale (NRS)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.

结局指标

主要结局

Mean change in short term effect of FBQP-AK-2024 in pain intensity by Numeric Rating Scale (NRS)

时间窗: Baseline, Day 7,Day 14

次要结局

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)

研究者

发起方

Akay Natural Ingredients Pvt. Ltd

申办方类型

Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients]

研究点 (1)

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