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

NCT03612986 | Completed

• 1 other identifier: OPRPH/0118/FS
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Visual Analogue Scale (VAS) results at moving. Change is being assessed.

  week 0, 4 and 16

• Visual Analogue Scale (VAS) results on pressing. Change is being assessed.

  week 0, 4 and 16

• Ultrasonography parameters results. Change is being assessed.

  week 0 and 16

• Knee injury and Osteoarthritis Outcome Score (KOOS). Change is being assessed.

  week 0, 4 and 16

• Index of Severity for Osteoarthritis of the Knee by Lequesne et al. Change is being assessed.

  week 0, 4 and 16

Other Outcomes (2)

• Safety outcomes assessed by number of adverse events (AE)/serious adverse events (SAE)

  day 0, week 4 and 16

• Safety assessment based on rescue medication (Paracetamol 500mg) administration

  day 0, week 4 and 16

Study Arms (2)

A: Active comparator SYALOX® 300 Plus

ACTIVE COMPARATOR

Active Nutraceutical containing HA and AKBA (SYALOX® 300 Plus) 1 tablet/day, oral administration

Dietary Supplement: SYALOX® 300 Plus

B: Placebo

PLACEBO COMPARATOR

Placebo 1 tablet/day, oral administration

Dietary Supplement: Placebo

Interventions

SYALOX® 300 Plus DIETARY_SUPPLEMENT

Reduction of pain and improvement of the knee mobility in patients affected by knee osteoarthritis

A: Active comparator SYALOX® 300 Plus

Placebo DIETARY_SUPPLEMENT

Placebo comparator. No chemical effect expected

B: Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• River Pharma S.r.l.: lead

Study Sites (1)

Opera Contract Research Organization S.r.l.

Timișoara, Timiș County, 300209, Romania

Location

Related Publications (37)

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Related Links

• Proverb resources: Ashanti Proverbs from Ghana

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Bogdan Andor, MD

  MEDICALI'S

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 2, 2018
• Study Start: August 22, 2018
• Primary Completion: April 10, 2019
• Study Completion: July 26, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-09

Locations

RO (1)