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Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain

NCT ID: NCT05597189

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2023-07-31

Brief Summary

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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

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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

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Supplementation Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Botanical extracts high dose

Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast.

Group Type EXPERIMENTAL

Experimental product

Intervention Type DIETARY_SUPPLEMENT

Botanical extract

Botanical extracts low dose

Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast.

Group Type EXPERIMENTAL

Experimental product

Intervention Type DIETARY_SUPPLEMENT

Botanical extract

Control group

Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast.

Group Type PLACEBO_COMPARATOR

Control product consumption

Intervention Type OTHER

Product with identical characteristics to the experimental product.

Interventions

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Experimental product

Botanical extract

Intervention Type DIETARY_SUPPLEMENT

Control product consumption

Product with identical characteristics to the experimental product.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women between 20 and 65 years of age.
* The subjects must have localized myofascial pain in the back area (cervical, dorsal and lumbar), with an evolution time of at least 3 months.
* The pain must present an initial score of at least 30 mm in the pain evaluation by means of the VAS scale.
* The pain must be episodic.
* BMI 18.5 - 29.9 kg/m2.
* Subjects should not be treated with narcotic drugs or steroidal anti-inflammatory drugs. steroidal anti-inflammatory drugs or immunosuppressants.

Exclusion Criteria

* Severe or terminal illnesses.
* Subjects with pain associated with trauma.
* Subjects with pain associated with chronic conditions (rheumatoid arthritis, herniated discs, ankylosing herniated disc, ankylosing spondylitis, etc.).
* Subjects with known allergy to any of the components of the investigational product. the investigational product.
* Subjects undergoing physiotherapy treatment during the course of the study. development of the study.
* Pregnant or lactating women.
* Inability to understand the informed consent.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Francisco Javier López Román

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University of Murcia

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UCAMCFE-00028

Identifier Type: -

Identifier Source: org_study_id