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Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis — SMILE  

Knee Osteoarthritis Clinical Trial

Official title:
Double Blind, Placebo Controlled Trial to Evaluate the Effects of a Nutraceutical Containing High-Molecular-Weight Hyaluronic Acid (HA) and Acetyl-11-Keto-Beta-Boswellic Acid (AKBA) in Patients Affected by Knee Osteoarthritis

Clinical Trial Summary

Double blind, placebo controlled trial to evaluate the effects of a nutraceutical containing high-molecular-weight hyaluronic acid (HA) and acetyl-11-keto-beta-boswellicacid (AKBA) in patients affected by knee osteoarthritis.

Clinical Trial Description

The primary objective of the trial is to assess the feasibility of implementing Ultrasonography and Range of Motion (ROM) as objective measurements to correlate the improvement of the knee mobility with the pain reduction of the affected knee in the patients assuming nutraceutical containing hyaluronic acid (HA).

The secondary objectives of the trial are:

- to assess the feasibility of implementing Actigraphy as objective measurements to correlate the improvement of the knee mobility with the pain reduction (optional).

- to evaluate the enrollment rate in one month.

The explorative objectives of the trial are:

• Preliminary data on efficacy of the tested product. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03612986
Study type Interventional
Source River Pharma S.r.l.
Contact
Status Completed
Phase N/A
Start date August 22, 2018
Completion date July 26, 2019
View Details
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