Condition category
Musculoskeletal Diseases
Date applied
21/08/2020
Date assigned
09/09/2020
Last edited
09/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

07/09/2020: Trial's existence confirmed by the Ethical Committee of College of Medicine, University of Sulaimani.