NCT05597189

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

November 27, 2023

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

October 24, 2022

Last Update Submit

November 23, 2023

Conditions

SupplementationBack Pain

Keywords

botanical extracts

Outcome Measures

Primary Outcomes (1)

  • Change in Pain from baseline at 12 weeks

    Visual analog scale from 0 to 10. The higher the value, the more pain.

    The evolution of pain after consumption during 12 weeks will be measured.

Secondary Outcomes (16)

  • Change in concomitant analgesic medication

    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

    Day 1, at 4, 8 and 12 weeks later

  • Evaluation of back pain: Cornell

    Day 1, at 4, 8 and 12 weeks later

  • Level of functionality: Roland Morris test

    Day 1, at 4, 8 and 12 weeks later

  • Quality of life questionnaire

    Day 1, at 4, 8 and 12 weeks later

  • +11 more secondary outcomes

Study Arms (3)

Botanical extracts high dose

EXPERIMENTAL

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

Dietary Supplement: Experimental product

Botanical extracts low dose

EXPERIMENTAL

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

Dietary Supplement: Experimental product

Control group

PLACEBO COMPARATOR

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

Other: Control product consumption

Interventions

Experimental productDIETARY_SUPPLEMENT

Botanical extract

Botanical extracts high doseBotanical extracts low dose
Control product consumptionOTHER

Product with identical characteristics to the experimental product.

Control group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 27, 2022

Study Start

September 26, 2022

Primary Completion

June 26, 2023

Study Completion

July 31, 2023

Last Updated

November 27, 2023

Record last verified: 2022-09

Locations

ES(1)