Health Condition 1: R52- Pain, unspecified
Conditions
Interventions
Intervention1: FBQP-AK-24: Oral administration of single dose of FBQP-AK-24 once a day for 14 days
Control Intervention1: Placebo: Oral administration of single dose of Placebo once a day for 14 days
Sponsors
Akay Natural Ingredients Pvt. Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in short term effect of FBQP-AK-2024 in pain intensity by Numeric Rating Scale (NRS)Timepoint: Baseline, Day 7,Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in functional capacityTimepoint: Baseline, Day 7,Day 14;Mean change in quality of lifeTimepoint: Baseline, Day 7,Day 14;Safety of FBQP-AK-2024Timepoint: Baseline and Day 14 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed