Effect of Arctium lappa root (Burdock) tea consumption on serum levels of oxidative stress markers, inflammatory markers, lipid profile and clinical symptoms in patient with knee osteoarthritis
The purpose of this study was to investigate the effects of Arctium lappa root (Burdock) tea consumption on serum levels of oxidative stress markers, inflammatory markers, lipid profile , clinical symptoms and nutritional status in patient with knee osteoarthritis. Inclusion criteria: age 50-70years old; primary bilateral knee osteoarthritis based on ACR criteria; ability to consume arctium lappa tea . Exclusion criteria: grade IV osteoarthritis; secondary OA; active synovitis; knee surgery or intra-articular injection; neuromuscular diseases; diabetes; metabolic diseases; cardiovascular diseases; hepatic diseases; smoking; alcohol and MI. A total of 42 patients(both of gender) grade 1-3 osteoarthritis, aged 50 to 70 years old, were randomly assigned into intervention or control group. The patients in both groups received physiotherapy (20 an-hour sessions for both knees) as well as Acetaminophen 500 mg twice a day and Glucosamine one tablet daily for 6 weeks. The patients in the intervention group received, as well, 6 grams of Arctium lappa root (Burdock) tea daily for 6 weeks. The inflammatory markers including IL-6 and hs-CRP as well as lipid profile, clinical signs , anti-oxidative status , anthropometric and dietary intake assessments were measured before and after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305274105N13
Registration date:2013-06-29, 1392/04/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-29, 1392/04/08
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Arctium lappa root (Burdock) tea consumption on serum levels of oxidative stress markers, inflammatory markers, lipid profile and clinical symptoms in patient with knee osteoarthritis
Public title
Effect of Arctium lappa root (Burdock) tea consumption on serum levels of oxidative stress markers, inflammatory markers, lipid profile and clinical symptoms in patient with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 50-70years old; primary bilateral knee osteoarthritis based on ACR criteria; ability to consume arctium lappa tea . Exclusion criteria: grade IV osteoarthritis; secondary OA; active synovitis; knee surgery or intra-articular injection; neuromuscular diseases; diabetes; metabolic diseases; cardiovascular diseases; hepatic diseases; smoking; alcohol and MI.
Age
From 50 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tabriz University of Medical Sciences
Street address
Attare Neyshaburi St, Tabriz, East Azarbijan, Iran
Analogue scale for weight and weight(Kg)/Square Height for body mass index
Intervention groups
1
Description
Arctium lappa root (Burdock) tea daily, for 6 weeks as well as physiotherapy (20 an-hour sessions for both knees), Acetaminophen 500mg twice a day, and Glucosamine one tablet daily for 6 weeks
Category
Treatment - Other
2
Description
control: Physiotherapy (20 an-hour sessions for both knees) as well as Acetaminophen 500mg twice a day and Glucosamine one tablet daily for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaa hospital, Tabriz university of medical science
Full name of responsible person
Dr Eftekhar Sadat
Street address
Golshahr St.Tabriz, East Azarbijan
City
Tabriz
2
Recruitment center
Name of recruitment center
Shahid Madani hospital, Tabriz university of medical science
Full name of responsible person
Dr Eftekhar Sadat
Street address
Daneshgah st.Tabriz, East Azarbijan
City
Tabriz
3
Recruitment center
Name of recruitment center
Faculty of Rehabilitation, Tabriz university of medical science
Full name of responsible person
Dr. Mir Ali Eteraf Oskouei, PhD, PT Dr. Mir Ali Eteraf Oskouei, PhD, PT
Street address
Faculty of Rehabilitation,Tavanir St.,ValiAsr Ave, Tabriz , East Azarbayjan
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Seyed Kazem Shakouri
Street address
Golbad Street, Tabriz, East Azarbayjan
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Maghsumi Noroozabad
Position
MSc student in nutrition sciences
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street
City
Tabriz
Postal code
Phone
00
Fax
Email
l.maghsumi55@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila Maghsumi Noroozabad
Position
MSc student in nutrition sciences
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street
City
Tabriz
Postal code
Phone
00
Fax
Email
l.maghsumi55@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)