NCT05597189

Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain

Clinical Study of Palliative / Preventive Treatment of Chronic Back Pain by Taking a Dietary Supplement Based on Botanical Extracts

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Universidad Católica San Antonio de Murcia · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Supplementation
• Back Pain

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Experimental product	Botanical extract
OTHER	Control product consumption	Product with identical characteristics to the experimental product.

Timeline

• Start date: 2022-09-26
• Primary completion: 2023-06-26
• Completion: 2023-07-31
• First posted: 2022-10-27
• Last updated: 2023-11-27

Locations

1 site across 1 country: Spain