Ignite Creation Date:
2024-05-06 @ 2:04 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04207021
Status:
UNKNOWN
Last Update Posted:
2019-12-20
First Post:
2019-12-13
Brief Title:
Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in Osteoarthritis
Sponsor:
KOS Care SRL - Istituto di Riabilitazione Santo Stefano
Organization:
KOS Care SRL - Istituto di Riabilitazione Santo Stefano
Study Overview
Official Title:
Evaluation of the Effectiveness of Curcumin-based Food Supplement in Reducing Pain and Inflammatory Component in People With Osteoarthritis
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FENOXI-1900
Brief Summary:
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
Inclusionexclusion criteria Inclusion criteria
Presence of osteoarthritis of the knee Traditional American College of Rheumatology criteria which are based on the presence of pain knee pain plus at least three of the following characteristics will be used for the diagnosis of osteoarthritis of the knee
Age 50 years
Stiffness in the morning 30 minutes
Presence of articular rusting
Painfulness of the bones
Tumefaction of the bones
Absence of palpable heat Knee pain in this study is defined as having experienced at least moderate pain in the most affected knee a score of 30 mm or more on an analog visual scale - VAS - as assessed by the patient for at least 25 of the previous 30 days
Exclusion criteria
pregnancy and breastfeeding
other specific contraindicationsintolerances to the compound
intake of other supplements
treatment with anti-inflammatory or pain-relieving drugs for other clinical conditions at the time of enrolment
Participation in other clinical studies All participants will be allowed to use analgesics eg paracetamol to control pain when needed The patient will however be required to avoid suspend the use of analgesics at least 12 hours before the baseline visit and subsequent checkups
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
Inclusionexclusion criteria Inclusion criteria
Presence of osteoarthritis of the knee Traditional American College of Rheumatology criteria which are based on the presence of pain knee pain plus at least three of the following characteristics will be used for the diagnosis of osteoarthritis of the knee
Age 50 years
Stiffness in the morning 30 minutes
Presence of articular rusting
Painfulness of the bones
Tumefaction of the bones
Absence of palpable heat Knee pain in this study is defined as having experienced at least moderate pain in the most affected knee a score of 30 mm or more on an analog visual scale - VAS - as assessed by the patient for at least 25 of the previous 30 days
Exclusion criteria
pregnancy and breastfeeding
other specific contraindicationsintolerances to the compound
intake of other supplements
treatment with anti-inflammatory or pain-relieving drugs for other clinical conditions at the time of enrolment
Participation in other clinical studies All participants will be allowed to use analgesics eg paracetamol to control pain when needed The patient will however be required to avoid suspend the use of analgesics at least 12 hours before the baseline visit and subsequent checkups
Detailed Description:
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 2day 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 patients 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 shoestouches
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 2day 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
In addition
Before enrolment all potentially eligible patients should receive full information about the study
In order to be enrolled patients must give their consent to the processing of personal data in anonymous and aggregate form in accordance with the GDPR European Regulation 6792016 on the Protection of Personal Data
the patient must be informed that his or her data may be examined by authorised personnel or members of the competent ethics committee and by officials of the competent regulatory authorities
Patient information and consent forms are included in the documentation attached to the request for approval by the Regional Ethics Committee
References
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 199134505-14
Arellano FM The withdrawal of rofecoxib Pharmacoepidemiology and Drug Safety 2005143213-217
Bannuru RR Osani MC Al-Eid F Wang C E Efficacy of curcumin and Boswellia for knee osteoarthritis Systematic review and meta-analysis Semin Arthritis Rheum 2018 Dec483416-429
Cavicchia PP Steck SE Hurley TG Hussey JR Ma Y Ockene IS Hébert JR A New Dietary Inflammatory Index Predicts Interval Changes in Serum High-Sensitivity C-Reactive Protein1-3 The Journal of Nutrition 2009 13912 2365-72
de Koning EJ Timmermans EJ van Schoor NM Stubbs B van den Kommer TN Dennison EM Limongi F Castell MV Edwards MH Queipo R Cooper C Siviero P van der Pas S Pedersen NL Sánchez-Martínez M Deeg DJH Denkinger MD EPOSA Group Within-Person Pain Variability and Mental Health in Older Adults With Osteoarthritis An Analysis Across 6 European Cohorts J Pain 2018 Jun196690-698
Felson DT Lawrence RC Hochberg MC et al Osteoarthritis new insights-part 2 treatment approaches Annals of Internal Medicine 20001339726-737
Herman CJ Allen P Hunt WC Prasad A Brady TJ Use of complementary therapies among primary care clinic patients with arthritis Preventing Chronic Disease 200411-15
Herold G Innere Medizin Köln Gerd Verlag 2007 614-615 Jordan KM Arden NK Doherty M et al EULAR recommendations 2003 an evidence based approach to the management of knee osteoarthritis report of a Task Force of the Standing Committee for International Clinical Studies including Therapeutic Trials ESCISIT Annals of the Rheumatic Diseases 2003621145-1155
Liu X Machado GC Eyles JP Ravi V Hunter DJ Dietary supplements for treating osteoarthritis a systematic review and meta-analysis Br J Sports Med 2018 Feb523167-175
Mobasheri A Henrotin Y Comment on Efficacy of Curcumin and Boswellia for knee osteoarthritis Systematic review and meta-analysis Semin Arthritis Rheum 2018 Apr 11
Moskowitz RW Abramson SB Berenbaum F Coxibs and NSAIDs-clearing the air Osteoarthritis and Cartilage 2005137545-547 PubMed National Institute of Arthritis and Musculosceletal and Skin Diseases Handout on Health Osteoarthritis May 2016 Available at httpwwwniamsnihgovHealth_InfoOsteoarthritisdefaultasp
Oliviero F Scanu A Zamudio-Cuevas Y Punzi L Spinella P Anti-inflammatory effects of polyphenols in arthritis J Sci Food Agric 2018 Mar9851653-1659
Sangha O Epidemiology of rheumatic diseases Rheumatology 200039supplement 23-12 PubMed World Health Organization Department of Reproductive Health and Research WHORHR and Johns Hopkins Bloomberg School of Public HealthCenter for Communication Programs CCP Knowledge for Health Project Family Planning A Global Handbook for Providers 2018 update Baltimore and Geneva CCP and WHO 2018
Zhang G Cao J Yang E Liang B Ding J Liang J Xu J Curcumin improves age-related and surgically induced osteoarthritis by promoting autophagy in mice Biosci Rep 2018 Jul 2384
Zhao P Cheng J Geng J Yang M Zhang Y Zhang Q Wang Y Lu B Curcumin protects rabbit articular chondrocytes against sodium nitroprusside-induced apoptosis in vitro Eur J Pharmacol 2018 Jun 5828146-153
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 2day 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 patients 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 shoestouches
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 2day 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
In addition
Before enrolment all potentially eligible patients should receive full information about the study
In order to be enrolled patients must give their consent to the processing of personal data in anonymous and aggregate form in accordance with the GDPR European Regulation 6792016 on the Protection of Personal Data
the patient must be informed that his or her data may be examined by authorised personnel or members of the competent ethics committee and by officials of the competent regulatory authorities
Patient information and consent forms are included in the documentation attached to the request for approval by the Regional Ethics Committee
References
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 199134505-14
Arellano FM The withdrawal of rofecoxib Pharmacoepidemiology and Drug Safety 2005143213-217
Bannuru RR Osani MC Al-Eid F Wang C E Efficacy of curcumin and Boswellia for knee osteoarthritis Systematic review and meta-analysis Semin Arthritis Rheum 2018 Dec483416-429
Cavicchia PP Steck SE Hurley TG Hussey JR Ma Y Ockene IS Hébert JR A New Dietary Inflammatory Index Predicts Interval Changes in Serum High-Sensitivity C-Reactive Protein1-3 The Journal of Nutrition 2009 13912 2365-72
de Koning EJ Timmermans EJ van Schoor NM Stubbs B van den Kommer TN Dennison EM Limongi F Castell MV Edwards MH Queipo R Cooper C Siviero P van der Pas S Pedersen NL Sánchez-Martínez M Deeg DJH Denkinger MD EPOSA Group Within-Person Pain Variability and Mental Health in Older Adults With Osteoarthritis An Analysis Across 6 European Cohorts J Pain 2018 Jun196690-698
Felson DT Lawrence RC Hochberg MC et al Osteoarthritis new insights-part 2 treatment approaches Annals of Internal Medicine 20001339726-737
Herman CJ Allen P Hunt WC Prasad A Brady TJ Use of complementary therapies among primary care clinic patients with arthritis Preventing Chronic Disease 200411-15
Herold G Innere Medizin Köln Gerd Verlag 2007 614-615 Jordan KM Arden NK Doherty M et al EULAR recommendations 2003 an evidence based approach to the management of knee osteoarthritis report of a Task Force of the Standing Committee for International Clinical Studies including Therapeutic Trials ESCISIT Annals of the Rheumatic Diseases 2003621145-1155
Liu X Machado GC Eyles JP Ravi V Hunter DJ Dietary supplements for treating osteoarthritis a systematic review and meta-analysis Br J Sports Med 2018 Feb523167-175
Mobasheri A Henrotin Y Comment on Efficacy of Curcumin and Boswellia for knee osteoarthritis Systematic review and meta-analysis Semin Arthritis Rheum 2018 Apr 11
Moskowitz RW Abramson SB Berenbaum F Coxibs and NSAIDs-clearing the air Osteoarthritis and Cartilage 2005137545-547 PubMed National Institute of Arthritis and Musculosceletal and Skin Diseases Handout on Health Osteoarthritis May 2016 Available at httpwwwniamsnihgovHealth_InfoOsteoarthritisdefaultasp
Oliviero F Scanu A Zamudio-Cuevas Y Punzi L Spinella P Anti-inflammatory effects of polyphenols in arthritis J Sci Food Agric 2018 Mar9851653-1659
Sangha O Epidemiology of rheumatic diseases Rheumatology 200039supplement 23-12 PubMed World Health Organization Department of Reproductive Health and Research WHORHR and Johns Hopkins Bloomberg School of Public HealthCenter for Communication Programs CCP Knowledge for Health Project Family Planning A Global Handbook for Providers 2018 update Baltimore and Geneva CCP and WHO 2018
Zhang G Cao J Yang E Liang B Ding J Liang J Xu J Curcumin improves age-related and surgically induced osteoarthritis by promoting autophagy in mice Biosci Rep 2018 Jul 2384
Zhao P Cheng J Geng J Yang M Zhang Y Zhang Q Wang Y Lu B Curcumin protects rabbit articular chondrocytes against sodium nitroprusside-induced apoptosis in vitro Eur J Pharmacol 2018 Jun 5828146-153
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None