Plain English Summary
Background and study aims
Osteoarthritis is a condition that causes joints to become painful and stiff. The treatment of knee osteoarthritis still remains a challenge. There is a need not only for effective and safe treatments but also for specific and reliable biomarkers that would help to observe both the progression of the disease and treatment effectiveness. Resveratrol extracted from Polygonum cuspidatum is a natural chemical that is found in grape skin, berries and peanuts. Pre-clinical studies provided evidence on the effectiveness of resveratrol in reducing degenerative articular damage. Recently a clinical study demonstrated the effectiveness of resveratrol as an add-on treatment in alleviating pain and reduction of inflammatory biomarkers. However, there are no clinical trials to date to determine the effectiveness of resveratrol as a treatment in articular disorders particularly in knee osteoarthritis and investigating biomarkers of cartilage breakdown. The aim of this study is to investigate the effects of resveratrol (as an oral capsule) in patients with mild or moderate knee osteoarthritis on the blood levels of specific biomarkers of osteoarthritis and on the evaluation of pain.
Who can participate?
Patients with mild to moderate osteoarthritis
What does the study involve?
The study will involve a 12-week of administration of oral resveratrol (500 mg/day in a single dose). A rescue medication (500 mg of acetaminophen and up to four tablets per day) will be given to the patients for non-tolerated pain they will experience during the study period. Specific biomarkers of osteoarthritis are measured before treatment (at day 0) and after 90 days of treatment.
What are the possible benefits and risks of participating?
The expected benefit of the current study is providing a new approach from a natural source Polygonum cuspidatum for the treatment of knee OA with fewer side effects and more regeneration of the cartilage. No risks are expected unless there might be a non-remarkable result due to the short duration of the study.
Where is the study run from?
Teaching Hospitals of Sulaimani City (particularly Shar Teaching Hospital) (Iraq)
When is the study starting and how long is it expected to run for?
December 2019 to October 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Assistant Professor Dr Bushra Hassan Marouf
bushra.marouf@univsul.edu.iq
Trial website
Contact information
Type
Public
Primary contact
Dr Bushra Marouf
ORCID ID
https://orcid.org/0000-0002-7658-9013
Contact details
Sulaimani-Old Campus
Sulaimani
00964
Iraq
+964 (0)7701562796
bushra.marouf@univsul.edu.iq
Type
Scientific
Additional contact
Dr Bushra Marouf
ORCID ID
https://orcid.org/0000-0002-7658-9013
Contact details
Sulaimani-Old Campus
Sulaimani
00964
Iraq
+964 (0)7701562796
bushra.marouf@univsul.edu.iq
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
A pilot clinical study of the effect of resveratrol on the serum level of Coll 2-1 and Aggrecan biomarkers in patients with knee osteoarthritis; a non-randomized open-labelled clinical trial
Acronym
APCERCA
Study hypothesis
Stated hypothesis: use of resveratrol (500 mg/day) alone may have a significant effect on the improvement of pain and specific biomarkers (Coll 2-1 and aggrecan) in patients with knee osteoarthritis.
Ethics approval
Approved 01/09/2020, Ethical Committee of College of Medicine, University of Sulaimani (Iraq-Kurdistan Region, Sulaimani, Street 27- Zone 209, Iraq; +964 (0)53 3270924; kosar.ali@univsul.edu.iq), ref: 180
Study design
Pilot clinical study of non-randomized non-controlled open-labelled clinical trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Knee osteoarthritis
Intervention
This is a single-arm non-randomized non-controlled open labelled clinical trial. The study will be a 12-week of administration of oral resveratrol (500 mg/day in a single dose) alone in patients with mild to moderate osteoarthritis. A rescue medication (500 mg of acetaminophen and up to four tablets per day) will be given to the patients for non-tolerated pain they experience during the study period. Resveratrol is a natural phytoalexin that is found in the grape skin, berries and peanuts.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
1. Specific biomarkers of osteoarthritis (Coll 2-1 and Aggrecan) measured using enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer instructions before treatment (at day 0) and after 90 days of treatment.
2. Biomarkers of inflammation including TNF-α, IL-1β, IL-6 (measured using ELISA kit according to the manufacturer instructions) and hsCRP and the complement system (measured by spectrophotometry utilizing ready-made kits and Roche/Hitachi cobas c systems) measured at baseline at Day 0 (pre-treatment) and at day 90 (post treatment)
3. Standard haematological profile (measured utilizing the Swelab Alfa Plus system) and both liver and kidney functions markers (liver and kidney function tests), and lipid profiles measured spectrophotometrically using the clinical chemistry analyzer Cobas c 311 and ready-made kits according to the manufacturer’s recommendations for evaluating safety and tolerability of resveratrol at baseline and at the end of the treatment
Secondary outcome measures
Symptoms of osteoarthritis measured using the adopted scoring systems of visual analogue scale for pain (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) at baseline (day 0), 1, 2 and 3 months
Overall trial start date
01/12/2019
Overall trial end date
01/10/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Mild to moderate OA at both screening and baseline visits, as defined by the up-to-date revised American College of Rheumatology (ACR) criteria for diagnosis of knee OA
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
35-40
Total final enrolment
35
Participant exclusion criteria
1. Patients with a history of rheumatoid arthritis, gout, severe ischaemic heart disease, heart failure, hepatic failure, renal failure
2. Consumption of non-steroidal anti-inflammatory drugs or corticosteroid drugs within 4 weeks of study, intra-articular injection within 3 months prior to the study recruitment
3. Pregnant or desire to become pregnant, or lactating women
Recruitment start date
10/01/2020
Recruitment end date
10/03/2020
Locations
Countries of recruitment
Iraq
Trial participating centre
University of Sulaimani
College of Pharmacy with Shar Teaching Hospital
46001 Sulaymaniyah
Kurdistan Region
Sulaimani
00964
Iraq
Sponsor information
Organisation
University of Sulaimani
Sponsor details
Department of Pharmacology and Toxicology
College of Pharmacy
Sulaimani-Old Campus
Sulaimani
00964
Iraq
+964 (0)7701562796
bushra.marouf@univsul.edu.iq
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The researchers plan to publish this work in a high-impact peer-reviewed Journal indexed in Web of Science group (former Clarivate Analytics or Thomson Reuters).
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Assistant Professor Dr Bushra Hassan Marouf (bushra.marouf@univsul.edu.iq).
Intention to publish date
10/10/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
nil