NCT03202901

Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers

Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers: a Pilot, Randomised, Parallel and Double Blind Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Technological Centre of Nutrition and Health, Spain · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

Join pain is a common cause of consultation in primary health care in the adult population. Indeed, people who suffer knee pain, mostly due to osteoarthritis, require analgesic treatment, often with some secondary effects. Therefore, the research to find a natural and efficient product to reduce knee pain in a short period of time, facilitating recovery after exercise and without side effects have an interest both for industry and for the general population. B-turmactive is an extract of Curcuma longa mixing two fractions in a single product: a) soluble fraction free-curcuminoids but rich in polysaccharides and b) curcuminoids fraction with cyclodextrin. Both fractions plus vitamin C are B-turmactive. Previous preclinical studies suggest that B-turmactive could exert an acute effect in healthy people that suffer mild or moderate knee pain and, furthermore could reduce inflammation process. Therefore, the goal of this study is to assess the short (acute) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain

Conditions

• Knee Injuries
• Inflammation Knees

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-19
• Primary completion: 2017-12-19
• Completion: 2017-12-19
• First posted: 2017-06-29
• Last updated: 2022-03-02

Locations

1 site across 1 country: Spain