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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: SYALOX® 300 Plus
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any gender and age from 45 to 70 years Symptomatic osteoarthritis (OA) of the knee with mild joint discomfort for at least 6 months prior to enrollment, following ACR criteria with history and physical examination(44). Subjects diagnosed with bilateral knee OA will be asked to specify the most affected knee at baseline, and this knee will be evaluated throughout the study period. Available confirmatory X-ray (performed within the previous 6 months) diagnosis (Kellgren/Lawrence score 2) at the evaluated knee joint(45). Subjects experienced pain for at least 15 of the 30 days prior to the start of the study. Exclusion Criteria: Subjects who have any inflammatory arthritic condition (different from the OA of the knee), fibromyalgia, multiple sclerosis or autoimmune disorder. Treatment with oral corticosteroids within 4 weeks before screening. Intra-articular injections of HA or corticosteroids in the target joint within 3 months before screening. Treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, methylsulfonylmethane, HA, diacerein) 2 weeks before the selection. HA-containing nutritional supplements or cosmetics during the month before the study. Previous surgical treatment of knee joint(s) or its necessity necessity for osteoarthritis (high tibial osteotomy, arthroplasty); complication(s) necessary for hospitalization and surgical treatment. Significant injury to the target joint within the past 6 months prior to screening (identified from medical history). Subjects following an energy-restricted diet for weight loss. Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception. Subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. Participation in an interventional clinical study in the previous 30 days. Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A: Active comparator SYALOX® 300 Plus<br>Active Nutraceutical containing HA and AKBA (SYALOX® 300 Plus) 1 tablet/day, oral administration | Dietary Supplement: SYALOX® 300 Plus<br>* Reduction of pain and improvement of the knee mobility in patients affected by knee osteoarthritis<br>|
| Placebo Comparator: B: Placebo<br>Placebo 1 tablet/day, oral administration | Dietary Supplement: Placebo<br>* Placebo comparator. No chemical effect expected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) results at rest. Change is being assessed. | Change in Visual Analogue Scale (VAS) results at rest, measured in mm | week 0, 4 and 16 | 
| Knee Range of Motion (ROM) results measured by goniometer. Change is being assessed. | Change in Range of Motion (ROM) results, measured in grades by goniometer. | week 0, 4 and 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) results at moving. Change is being assessed. | Change in Visual Analogue Scale (VAS) results at moving, measured in mm | week 0, 4 and 16 | 
| Visual Analogue Scale (VAS) results on pressing. Change is being assessed. | Change in Visual Analogue Scale (VAS) results at pressing, measured in mm | week 0, 4 and 16 | 
| Ultrasonography parameters results. Change is being assessed. | Change of presence or absence of Synovial fluid, Articular cartilage damage, Medial meniscal protrusion, Lateral meniscal protrusion, Medial osteophytes, Lateral osteophytes, Enthesopathies, Effusion is being assessed. | week 0 and 16 | 
| Knee injury and Osteoarthritis Outcome Score (KOOS). Change is being assessed. | Change in parameters of quality of life will be assessed through Knee injury and Osteoarthritis Outcome Score (KOOS). | week 0, 4 and 16 | 
| Index of Severity for Osteoarthritis of the Knee by Lequesne et al. Change is being assessed. | Change in parameters of quality of life will be assessed through Index of Severity for Osteoarthritis of the Knee by Lequesne et al. | week 0, 4 and 16 | 
| Knee movement results using an actimeter (accelerometer). Change is being assessed. | Knee movement based on acceleration results using an actimeter, device based on an accelerometer. The results will be measured in meter/second squared (m/s2) Change is being assessed. | week 0 and 16 |