Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers
NCT03202901 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2022-03-02
Summary
The goal of this study is to assess the short (acutte) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain
Conditions
- Knee Injuries
- Inflammation Knees
Interventions
- DIETARY_SUPPLEMENT
-
B-turmactive
The treatment consists of daily administration of B-TURMACTIVE®. Treatment with B-TURMACTIVE® will last 7 days to determine the effects of the product in the short term, during which the volunteers will be visited 4 times: V0 screening: to evaluate the inclusion and exclusion criteria. V1 inclusion and randomisation (Day 1): 1st day treatment and intervention. Measure primary and secondary variables V2 (Day 3): the primary endpoint will be monitored by telephone (perception of pain). V3 (Day 7): Day 7 of treatment and final intervention. Measure primary and secondary variable
- DIETARY_SUPPLEMENT
-
Placebo
The treatment consists of daily administration of placebo capsule with identical format and harmless thant B-turmactive product. Treatment with placebo will last 7 days to determine the effects of the product in the short term, during which the volunteers will be visited 4 times: V0 screening: to evaluate the inclusion and exclusion criteria. V1 inclusion and randomisation (Day 1): 1st day treatment and intervention. Measure primary and secondary variables V2 (Day 3): the primary endpoint will be monitored by telephone (perception of pain). V3 (Day 7): Day 7 of treatment and final intervention. Measure primary and secondary variable
Sponsors & Collaborators
-
Hospital Universitari Sant Joan de Reus
collaborator OTHER -
University Rovira i Virgili
collaborator OTHER -
Technological Centre of Nutrition and Health, Spain
lead OTHER
Principal Investigators
-
Rosa M Valls, PhD · University Rovira i Virgili
-
Rosa Solà, MD, PhD · Hospital Universitari Sant Joan, Universitat Rovira i Virgili, CTNS
-
Anna Pedret, PhD · University Rovira i Virgili
-
Elisabet Llauradó, PhD · University Rovira i Virgili
-
Montse Giralt, MD, PhD · University Rovira i Virgili
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-09-19
- Primary Completion
- 2017-12-19
- Completion
- 2017-12-19
Countries
- Spain
Study Locations
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