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

September 30, 2019 updated by: River Pharma S.r.l.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timişoara, Timis, Romania, 300209
        • Opera Contract Research Organization S.r.l.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: Active comparator SYALOX® 300 Plus

Active Nutraceutical containing HA and AKBA (SYALOX® 300 Plus)

1 tablet/day, oral administration
Dietary supplement: SYALOX® 300 Plus
Reduction of pain and improvement of the knee mobility in patients affected by knee osteoarthritis
Placebo Comparator: B: Placebo

Placebo

1 tablet/day, oral administration
Dietary supplement: Placebo
Placebo comparator. No chemical effect expected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) results at rest. Change is being assessed.
Time Frame: week 0, 4 and 16
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.
Time Frame: week 0, 4 and 16
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.
Time Frame: week 0, 4 and 16
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.
Time Frame: week 0, 4 and 16
Change in Visual Analogue Scale (VAS) results at pressing, measured in mm
week 0, 4 and 16
Ultrasonography parameters results. Change is being assessed.
Time Frame: week 0 and 16
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.
Time Frame: week 0, 4 and 16
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.
Time Frame: week 0, 4 and 16
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.
Time Frame: week 0 and 16
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety outcomes assessed by number of adverse events (AE)/serious adverse events (SAE)
Time Frame: day 0, week 4 and 16
Adverse events (AE)/serious adverse events (SAE) (number of events occured, related to the investigational product administration)
day 0, week 4 and 16
Safety assessment based on rescue medication (Paracetamol 500mg) administration
Time Frame: day 0, week 4 and 16
Safety assessed by the number of rescue medication tablets administered daily.
day 0, week 4 and 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

River Pharma S.r.l.

Investigators

  • Principal Investigator: Bogdan Andor, MD, MEDICALI'S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2018

Primary Completion (Actual)

April 10, 2019

Study Completion (Actual)

July 26, 2019

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPRPH/0118/FS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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