Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis
NCT ID: NCT03612986
Last Updated: 2019-10-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
72 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-22
Study Completion Date
2019-07-26
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.
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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.
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.
Conditions
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Knee Osteoarthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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A: Active comparator SYALOX® 300 Plus
Active Nutraceutical containing HA and AKBA (SYALOX® 300 Plus)
1 tablet/day, oral administration
Group Type
ACTIVE_COMPARATOR
SYALOX® 300 Plus
Intervention Type
DIETARY_SUPPLEMENT
Reduction of pain and improvement of the knee mobility in patients affected by knee osteoarthritis
B: Placebo
Placebo
1 tablet/day, oral administration
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DIETARY_SUPPLEMENT
Placebo comparator. No chemical effect expected
Interventions
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SYALOX® 300 Plus
Reduction of pain and improvement of the knee mobility in patients affected by knee osteoarthritis
Intervention Type
DIETARY_SUPPLEMENT
Placebo
Placebo comparator. No chemical effect expected
Intervention Type
DIETARY_SUPPLEMENT
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.
* 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.
* 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.
Minimum Eligible Age
45 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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River Pharma S.r.l.
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Bogdan Andor, MD
Role: PRINCIPAL_INVESTIGATOR
MEDICALI'S
Locations
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Opera Contract Research Organization S.r.l.
Timișoara, Timiș County, Romania
Site Status
Countries
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Romania
References
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Related Links
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http://cogweb.ucla.edu/Discourse/Proverbs/Ashanti.html
Proverb resources: Ashanti Proverbs from Ghana
Other Identifiers
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OPRPH/0118/FS
Identifier Type: -
Identifier Source: org_study_id
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