Effect of resveratrol capsules on knee osteoarthritis symptoms and specific markers of joint breakdown
| ISRCTN | ISRCTN75392625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75392625 |
- Submission date
- 21/08/2020
- Registration date
- 09/09/2020
- Last edited
- 06/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Sulaimani-Old Campus
Sulaimani
00964
Iraq
 ORCID ID |
0000-0002-7658-9013 |
|---|---|
| Phone | +964 (0)7701562796 |
| bushra.marouf@univsul.edu.iq |
Scientific
Sulaimani-Old Campus
Sulaimani
00964
Iraq
| ORCID ID |
0000-0002-7658-9013 |
|---|---|
| Phone | +964 (0)7701562796 |
| bushra.marouf@univsul.edu.iq |
Study information
| Study design | Pilot clinical study of non-randomized non-controlled open-labelled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study acronym | APCERCA |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2019 |
| Completion date | 01/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 35-40 |
| Total final enrolment | 35 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/01/2020 |
| Date of final enrolment | 10/03/2020 |
Locations
Countries of recruitment
- Iraq
Study participating centre
46001 Sulaymaniyah
Kurdistan Region
Sulaimani
00964
Iraq
Sponsor information
University/education
Department of Pharmacology and Toxicology
College of Pharmacy
Sulaimani-Old Campus
Sulaimani
00964
Iraq
| Phone | +964 (0)7701562796 |
|---|---|
| bushra.marouf@univsul.edu.iq |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 14/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/11/2021 | 16/11/2021 | Yes | No | |
| Protocol file | 06/10/2022 | No | No |
Additional files
Editorial Notes
06/10/2022: Uploaded protocol (not peer reviewed).
16/11/2021: Publication reference added.
14/05/2021: The intention to publish date has been changed from 10/10/2020 to 14/11/2021.
07/09/2020: Trial's existence confirmed by the Ethical Committee of College of Medicine, University of Sulaimani.
