Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in Osteoarthritis (FENOXI-1900)
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|ClinicalTrials.gov Identifier: NCT04207021|
Recruitment Status : Not yet recruiting
First Posted : December 20, 2019
Last Update Posted : December 20, 2019
|First Submitted Date ICMJE||December 13, 2019|
|First Posted Date ICMJE||December 20, 2019|
|Last Update Posted Date||December 20, 2019|
|Estimated Study Start Date ICMJE||December 18, 2019|
|Estimated Primary Completion Date||April 30, 2020 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||- variation in the level of joint function measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 0, 6 weeks ]
WOMAC scale is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The test questions are scored on a 0-4 scale, corresponding to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up; higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in Osteoarthritis|
|Official Title ICMJE||Evaluation of the Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in People With Osteoarthritis|
INTRODUCTION The treatment of OA is mostly symptomatic and includes the use of analgesics, NSAIDs, exercise and even surgery. However, the use of long-term NSAIDs is associated with potentially serious side effects. As a result, the use of alternative and complementary therapies (CAM), such as nutritional therapies in patients with OA, is extremely frequent.
The objective of this study will be to evaluate the effectiveness of a dietary supplement based on curcumin, polydatin and beta-caryophyllene, on the reduction of pain and inflammatory component in individuals with knee OA.
MATERIAL AND METHOD Study design Intervention study with two parallel arms, randomized, double-blind, placebo-controlled.
Study population Participants in the study will be recruited at the Santo Stefano Rehabilitation Institute. The first group will be treated with curcumin-based supplement for 6 weeks; the second group will be treated with placebo for 6 weeks.
Inclusion/exclusion criteria Inclusion criteria
INTRODUCTION Gonarthrosis is the most common disorder of the musculoskeletal system, with an age-related prevalence varying between 12-55%. The treatment of OA is mostly symptomatic and includes the use of analgesics, NSAIDs, exercise and even surgery. However, the use of long-term NSAIDs is associated with potentially serious side effects, with a high risk of hospitalization and death. As a result, the use of alternative and complementary therapies (CAM), such as nutritional therapies in patients with OA, is extremely frequent.
The objective of this study will be to evaluate the effectiveness of a dietary supplement based on curcumin, polydatin and beta-caryophyllene (FENOXIDOL™-Mivell), on the reduction of pain and inflammatory component in individuals with knee OA.
MATERIAL AND METHOD Study design Intervention study with two parallel arms, randomized, double-blind, placebo-controlled to assess the effectiveness of the dietary supplement in reducing perceived pain, will also be evaluated secondarily the improvement of joint function, changes in serum levels of PCR, inflammatory cytokines (TNF-alpha and IL-6) and nitrates / nitrites at the level of saliva and any change in the use of painkillers when needed.
Intervention Intervention group: the study involves the intake of two capsules per day, one capsule to be taken before breakfast and one before dinner for a period of 6 weeks.
The FENOXIDOL™ supplement and its placebo (visually identical capsules, but without active ingredients) will be supplied by the company Mivell Srls participating in the PrIntAge project. For the composition of the placebo, see the declaration attached to this document by Mivell Srls.
FENOXIDOL™ is a natural anti-inflammatory supplement designed to counteract, without any known side effects, acute and chronic inflammatory phenomena, especially those associated with joints, muscles and bones. The product has been formulated using naturally derived extracts in the quantities shown in the table below.
PHENOXIDOL CAPSULE COMPOSITION active substances for 1 capsule for 2 capsules Bio Curcumin 200 mg 400 mg Polydatin 50 mg 100 mg Beta-Caryophyllene 24 mg 48 mg
It should be noted that the product FENOXIDOL™ and its components have not been associated to date with any side effects, the active ingredients of the formula are all listed in Annex 1 of the Italian Ministry Decree of 10 August 2018 governing the use in food supplements of herbal substances and preparations as updated by Decree 9 January 2019.
It should also be noted that the FENOXIDOL™ product has no Gluten Free certification.
Placebo group: the study involves taking two capsules per day of placebo, one capsule before breakfast and one before dinner for a period of 6 weeks.
The placebo will consist of capsules with no active ingredients containing cellulose, fatty acid magnesium salts, and silicon dioxide.
All participants will be allowed to use anti-inflammatory drugs (ibuprofen up to 400 mg per 2/day) to control pain, if needed. The patient will, however, be required to avoid / suspend the use of anti-inflammatory at least 12 hours before the visit to baseline and subsequent checkups and to record the use.
Treatment, randomisation and blinding kits Mivell Srls will prepare patient kits containing treatment capsules in proportion to the time of administration and sample size considered and will send them by courier to the Pharmacy of the Istituto di Riabilitazione Santo Stefano. In order to carry out the double-blind study, these kits will be assigned, by Mivell Srls, identification codes based on the randomization lists generated by a statistical software. Blinding will be maintained for the entire duration of the study, until the analysis of the data and, possibly, interrupted only at the time of highlighting potential adverse winds in the participants.
The patient's compliance with the treatment will be calculated on the basis of the percentage of residual doses at the end of the study and on the basis of the compilation of a diary.
Biological samples and data collection Data will be collected on age, gender, educational level, BMI, employment, physical activity at work and in leisure time (IPAQ Questionnaire), tobacco habits, presence of comorbidity, type of diet (food frequency questionnaire related to the last week, with particular regard to the intake of substances with anti-inflammatory / antioxidant power, eg: seeds and dried fruit, dark chocolate, bananas, avocado, soya products, leafy vegetables, fish, garlic, curry, rosemary, ginger, saffron, (see Cavicchia, 2009), use of drugs (with particular regard to the frequency of taking painkillers and anti-inflammatory drugs in the previous six weeks) and supplements. The following will also be evaluated: duration of the disease, presence of osteoporosis, orthopaedic-neurological comorbidity, trauma, type of work, obligatory postures, use of special shoes/touches.
The objective examination will allow the evaluation of the degree of joint impairment, the completion of the WOMAC questionnaire, the pVAS scale (Visual Analogue Scale for pain), knee height from the ground, A diary of the frequency of use of pain control drugs (ibuprofen up to 400mg 2/day), to be completed by the patient or care-giver, will also be delivered.
The volume of blood collected will be 5 ml, as part of the blood sample performed for chemical and clinical tests provided for in normal clinical practice.
Blood sample testing will be performed immediately after collection at GSS Laboratories, using standard methods.
The concentration of nitrites and nitrates, IL-1 beta, IL-6 and TNF-alpha will be evaluated at the salivary level. Salivary collection will be done by means of Salivets. Dosages of nitrite and nitrate, IL-6 and TNF-alpha will be conducted on morning saliva sample. Salivary samples will be processed at the Laboratory of Molecular Biology of the Hygiene Section of the Department of Biomedical Sciences and Public Health - Polytechnic University of Marche, with delivery within the day or refrigerated for a maximum of 4 days before transport from GSS premises to the analysis laboratory.
Adverse reactions There are currently no adverse reactions associated with taking FENOXIDOL™ as a dietary supplement. However, in this study, all adverse reactions reported spontaneously by the patient or detected by the investigator will be reported on the Case Report Form (CRF).
ETHICAL AND LEGAL ASPECTS The procedures in the study regarding conduct, conduct and documentation have been prepared to ensure compliance with the ethical principles set out in the Helsinki Declaration and its revisions. The design of the research also included guidelines for Good Clinical Practice (GCP).
The study will be conducted taking into account regulatory requirements and legal requirements and the study will be initiated following the obtaining of the evaluation and approval of the study by the Regional Ethics Committee and the completion of administrative requirements provided by the institution where the study is conducted.
Altman R, Alarcón G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991;34:505-14.
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|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||June 30, 2020|
|Estimated Primary Completion Date||April 30, 2020 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||50 Years to 100 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT04207021|
|Other Study ID Numbers ICMJE||FENOXI-19|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||KOS Care SRL - Istituto di Riabilitazione Santo Stefano|
|Study Sponsor ICMJE||KOS Care SRL - Istituto di Riabilitazione Santo Stefano|
|Collaborators ICMJE||Not Provided|
|PRS Account||KOS Care SRL - Istituto di Riabilitazione Santo Stefano|
|Verification Date||December 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP