Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a botanical supplement on the prevention of non-joint pain.
Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned). The product to be consumed is a Botanical Extract. Participants will consume the product for 84 days. It should be taken half an hour before breakfast, two capsules per day. The study subjects will have to make 5 visits to the laboratory. On the first and last visit, they will have their blood drawn, their sleep quality will be evaluated and they will complete a series of questionnaires to evaluate their quality of life and type of back pain. In the rest of the visits they will only have to take the tests on paper.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
135
Botanical extract
Product with identical characteristics to the experimental product.
Catholic University of Murcia
Murcia, Spain
Change in Pain from baseline at 12 weeks
Visual analog scale from 0 to 10. The higher the value, the more pain.
Time frame: The evolution of pain after consumption during 12 weeks will be measured.
Change in concomitant analgesic medication
The change in the need for the use of analgesic medications will be evaluated
Time frame: The test will be measured at baseline and after 12 weeks of consumption. It will also be evaluated on a daily basis
Evaluation of back pain: Promis-29 test
Back pain will be measured with the Promis-29 v2.0 test. This is a 29-item test that measures the degree of pain.
Time frame: Day 1, at 4, 8 and 12 weeks later
Evaluation of back pain: Cornell
The Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) assesses musculoskeletal symptomatology in workers who perform sedentary and standing work. sedentary work and standing work.
Time frame: Day 1, at 4, 8 and 12 weeks later
Level of functionality: Roland Morris test
The Roland-Morris questionnaire is used to reliably determine the degree of physical degree of physical disability derived from non-specific low back pain.
Time frame: Day 1, at 4, 8 and 12 weeks later
Quality of life questionnaire
SF-36 test health questionnaire
Time frame: Day 1, at 4, 8 and 12 weeks later
Wellbeing / wellness
WHOQOL BREF test
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Time frame: Day 1, at 4, 8 and 12 weeks later
Depression
Beck depression. Test to measure the level of depression of the subjects
Time frame: Day 1, at 4, 8 and 12 weeks later
Anxiety questionnaire
Test STAI, to measure the level of anxiety of the subjects
Time frame: Day 1, at 4, 8 and 12 weeks later
Perceived stress
Remor, 2001. Test to measure the level of stress of the subjects
Time frame: Day 1, at 4, 8 and 12 weeks later
Sleep quality
Measured by Pittsburgh test
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Body composition
It is a control variable. Measured by bioimpedance
Time frame: The test will be measured at baseline and after 12 weeks of consumption.
Physical activity
It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT
Time frame: The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
Sleep efficiency
Measured by accelerometry, with Actigraph wGT3X-BT
Time frame: The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
C Reactive Protein (PCR)
It is a blood test that measures inflammation levels.
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks.
Interleukin 6 (IL-6)
It is a blood test that measures inflammation levels.
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks.
Liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks.