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

Knee Osteoarthritis Clinical Trial

— SMILE  

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 Details — Status: Completed

Administrative data

• NCT number: NCT03612986
• Other study ID #: OPRPH/0118/FS
• Status: Completed
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: July 26, 2019

Study information

• Verified date: September 2019
• Source: River Pharma S.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 26, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• SYALOX® 300 Plus
Reduction of pain and improvement of the knee mobility in patients affected by knee osteoarthritis
• Placebo
Placebo comparator. No chemical effect expected

Locations

Country	Name	City	State
Romania	Opera Contract Research Organization S.r.l.	Timisoara	Timis

Sponsors (1)

Lead Sponsor	Collaborator
River Pharma S.r.l.

Country where clinical trial is conducted

Romania, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

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

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