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Effects of artichoke leaf extract supplementation on oxidative stress status, inflammatory markers and clinical symptoms in patients with knee osteoarthritis

Protocol summary

Study aim
This study aimed to investigate the effect of artichoke leaf extract supplementation on oxidative stress status, inflammatory markers and clinical symptoms in patients with knee osteoarthritis
Design
This study is a two-arm parallel group randomized trial, conducted on 46 patients with knee osteoarthritis.
Settings and conduct
This randomized double blind placebo controlled trial will be performed in Zabol city. Participants will be randomly allocated to intervention and control groups.Participants and the principal investigator will be blinded to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness and ability to collaborate on project, aged 40-70 years from both sex, confirmation of bilateral primary knee osteoarthritis, body mass index between 25-35 kg/m2, Consumption of glucoseamine, chondrotin sulphate supplements and acetaminophene as anti-pain drug Exclusion criteria: Alcohol consumption; smoking; pregnant and lactating women; having an active synovitis; affected by cardiovascular disease, renal failure, diabetes mellitus, liver dysfunction, cancer; consumption of Furosemide, Probenecid, Sulphonamides, Methotrexate; Consumption of fish oil supplement or other antioxidant supplements currently or within 3 months before intervention; history of allergy to artichoke family plants and their products
Intervention groups
Subjects in the intervention group will receive four pills of artichoke leaf extract (each containing 450 mg, totaling 1800 mg daily), and placebo group will receive four placebo pills (containing corn flour) for 12 weeks.
Main outcome variables
Main outcome variables: Clinical symptoms including pain, joint stiffness and disability; Inflammatory markers including interleukin 1β (IL-1β), IL-6, and TNF-α; Oxidative markers including malondialdehyde (MDA), total antioxidant capacity (TAC), and total oxidant capacity (TOS).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250515065755N1
Registration date: 2025-05-29, 1404/03/08
Registration timing: prospective

Last update: 2025-05-29, 1404/03/08
Update count: 0
Registration date
2025-05-29, 1404/03/08
Registrant information
Name
Farshad Amirkhizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3223 2107
Email address
amirkhizi@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-23, 1404/05/01
Expected recruitment end date
2026-07-23, 1405/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of artichoke leaf extract supplementation on oxidative stress status, inflammatory markers and clinical symptoms in patients with knee osteoarthritis
Public title
Effects of artichoke leaf extract in knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness and ability to collaborate on project aged 40-70 years from both sex Confirmation of bilateral primary knee osteoarthritis Body mass index between 25-35 kg/m2 Consumption of glucoseamine, chondroitin sulfate supplements and acetaminophen as anti-pain drug
Exclusion criteria:
Alcohol consumption Smoking Pregnant and lactating women Secondary osteoarthritis Having an active synovitis Having a history of knee injection within 6 months before intervention Neurological disorder that affects movement, muscle control and balance Affected by cardiovascular disease, renal failure, diabetes mellitus, liver dysfunction, cancer; affected by infectious or inflammatory disease or recent surgery Consumption of Furosemide, Probenecid, Anticoagulants, Anticonvulsant drugs, Sulphonamides, Methotrexate, Lithium salts and muscle relaxants currently or within 3 months before intervention Consumption of fish oil supplement or other antioxidant supplements currently or within 3 months before intervention History of allergy to artichoke family plants and their products
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly assigned to study groups using a block randomization procedure of size 4 and will be stratified by sex, age, and BMI. The Random Allocation Software (RAS) will be used by the study statistician to generate a random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both participants and the principal investigator will be blinded to the study groups. To ensure that researchers and participants remain unaware of the type of supplement being administered, both the supplement and placebo will be placed in identical containers labeled with the appropriate code by an individual who is not the investigator, following a predetermined coding system.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zabol University of Medical Sciences
Street address
Shahid Bagheri Ave, Shahid Rajaei St
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Approval date
2025-03-04, 1403/12/14
Ethics committee reference number
IR.ZBMU.REC.1403.152

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Pain
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
WOMAC questionnaire

2

Description
Joint stiffness
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
WOMAC questionnaire

3

Description
Disability
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
WOMAC questionnaire

4

Description
Oxidative markers
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Total antioxidant capacity (TAC) by using spectrophotometry, MDA by using thiobarbituric acid, Total oxidant capacity by using ELISA kit

5

Description
Inflammatory markers
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Serum levels of TNF-α، IL-1β and IL-6 by using ELISA kits

Secondary outcomes

1

Description
Anthropometric measurements
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Weight and Height by using Seca scale and stadiometer respectively, waist circumference by using tape measure, Body mass index (BMI) will be calculated as weight in kilograms divided by the square of height in meters

2

Description
Energy and macro-nutrients intake
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
3-day 24 hours food recall

Intervention groups

1

Description
Intervention group: 1800 mg artichoke leaf extract as 4 tablets per day for 12 weeks
Category
Treatment - Other

2

Description
Control group: 1800 mg placebo containing corn starch as 4 tablets per day for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Farshad Amirkhizi
Street address
Kilometer 3 Zabol Road - Zahedan
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2190
Email
amirkhizi@zbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Bahman Fouladi
Street address
Shahid Rajaee Ave., Shahid Rajaee St.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 0768
Email
fouladi@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Farshad Amirkhizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Bagheri Ave., Shahid Rajaee St.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2190
Email
amirkhizi@zbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Farshad Amirkhizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Bagheri Av., Shahid Rajaee St.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2190
Email
amirkhizi@zbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Farshad Amirkhizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Bagheri Ave., Shahid Bagheri St.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2190
Email
amirkhizi@zbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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