Clinical trial NCT03612986: Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: River Pharma S.r.l.
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 72
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale (VAS) results at rest. Change is being assessed.
timeFrame: week 0, 4 and 16
measure: Knee Range of Motion (ROM) results measured by goniometer. Change is being assessed.
timeFrame: week 0, 4 and 16
Secondary outcomes:
measure: Visual Analogue Scale (VAS) results at moving. Change is being assessed.
timeFrame: week 0, 4 and 16
measure: Visual Analogue Scale (VAS) results on pressing. Change is being assessed.
timeFrame: week 0, 4 and 16
measure: Ultrasonography parameters results. Change is being assessed.
timeFrame: week 0 and 16
measure: Knee injury and Osteoarthritis Outcome Score (KOOS). Change is being assessed.
timeFrame: week 0, 4 and 16
measure: Index of Severity for Osteoarthritis of the Knee by Lequesne et al. Change is being assessed.
timeFrame: week 0, 4 and 16
measure: Knee movement results using an actimeter (accelerometer). Change is being assessed.
timeFrame: week 0 and 16
Other outcomes:
measure: Safety outcomes assessed by number of adverse events (AE)/serious adverse events (SAE)
timeFrame: day 0, week 4 and 16
measure: Safety assessment based on rescue medication (Paracetamol 500mg) administration
timeFrame: day 0, week 4 and 16
Locations:
city: Timişoara
country: Romania
facility: Opera Contract Research Organization S.r.l.
state: Timis
Study officials:
affiliation: MEDICALI'S
name: Bogdan Andor, MD
role: PRINCIPAL_INVESTIGATOR
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