The effect of chamomile (Matricaria recutita L.) on serum levels of tumor necrosis factor-α (TNF-α), interlukin-1β and matrix metalloproteinase-3 (MMP3) in rheumatoid arthritis women patients: a randomized controlled clinical trial
Forty four adult female patients with rheumatoid arthritis (RA), diagnosed in accordance with criteria suggested by 2010 American College of Rheumatology (ACR) criterion, with remission to moderate disease activity score will be recruited in the study. Although patients receiving inconstant drug prescription for 3 weeks before and during the intervention, subjects suffering from inflammatory or metabolic disorders and those with pregnancy or lactation will be excluded. The participants will be assigned into treatment group (22subject) and control group (22subject) using permuted-blocks randomization and will receive two glasses of chamomile and placebo herbal tea for 6 weeks. To determine the effects of chamomile on patient’s clinical status, disease activity score (DAS-28) will be calculated before and after the intervention for each group. Inflammatory biomarkers such as interlukin-1β, TNF-α (tumor necrosis factor-α) and MMP-3 (matrix metalloproteinase 3) will be measured with ELISA method in serum samples collected before and after the study (6weeks). Finally, to manage effects of any confounder variable, anthropometric indicators, physical activity level and mental anxiety status will be measured and a three-day food record will be kept in two period, in onset and end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010111335N4
Registration date:2015-01-28, 1393/11/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-28, 1393/11/08
Registrant information
Name
Saeed Pirouzpanah
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133575803
Email address
pirouzpanahs@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chamomile (Matricaria recutita L.) on serum levels of tumor necrosis factor-α (TNF-α), interlukin-1β and matrix metalloproteinase-3 (MMP3) in rheumatoid arthritis women patients: a randomized controlled clinical trial
Public title
The effect of chamomile (Matricaria recutita L.) on serum levels of tumor necrosis factor-α (TNF-α), interlukin-1β and matrix metalloproteinase-3 (MMP3) in rheumatoid arthritis women patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Subjects diagnosed with rheumatoid arthritis, based on American College of Rheumatology (ACR-2010) criteria; 2) Patients with moderate and less rheumatoid arthritis score (DAS-28<5.1); 3) Stable medication for at least 3 weeks prior to the intervention and during that; 4) Willing to participate in the study and giving written consent ; 5) Ages between 20 and 65; 6) Have a body mass index (BMI) less than 30 and more than 18.5
Exclusion criteria: 1) Pregnant and lactating women; 2) Patients with cardiovascular, lung, hepatic, kidney and blood diseases; 3) Having chronic inflammatory diseases such as Sjogern, Sicca, Multiple sclerosis, Lupus Erythematosus and Hashimoto’s diseases; 4) Patients with gastroduodenal ulcer; 5) Patients with a high sensibility to the experimental drugs; 6) Patients participating in another study just 3 weeks before the intervention; 7) Taking any vitamin, mineral or omega 3 supplement 3 months before the intervention.
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Regard to compliance criterion, subjects will receive similar packets and teabags (shape, size, color were similar) containing chamomile and placebo. For being sure that diet pattern had no change during the study, patients were asked to fill 3 days 24-hours food record before and after the intervention. Patients were requested to continue to their usual life style and diet pattern during run-out period. Although physical activity and drug usage will be questioned in 3 weeks intervals and at the end of study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Tabriz University of Medical Science
Street address
Golbad Street, Tabriz, Eastern Azarbaijan, Islamic Republic Of Iran
The case group will receive two glasses of chamomile tea, containing 3 grams chamomile (plus 3 grams bran) brewed in 150 ml of water every day for six consecutive weeks. Chamomile flowers will be dried with a standard method and away from the light and in an instant time interval. Plant species will be confirmed by herbarium. Tea packing will be done in the tea company. All the patients will receive the supplements on the onset of the study and will be monitored for consumption continuation and any possible adverse effects by telephone calls. In addition consumption check lists were collected every 3 weeks during the study. Before the intervention of study, a run out period was planned for flavonoid rich foods such as black tea (less than 2 cups with 240ml volume), onion, and green leafy vegetables seven days before the intervention and during the study. Investigator and patients were blinded about grouping the participants into placebo or intervention group. Tea bags were distributed to participants with similar packing which was coded by producer factory. Subjects were requested to follow their usual diet and physical activity plan of their life.
Category
Treatment - Other
2
Description
The control group as placebo will receive two tea bags containing 3 grams of wheat bran as placebo every day for six consecutive weeks. The placebo packing will be done in the tea company. All the patients will receive the placebos on the onset of the study and will be monitored for consumption continuation and any possible adverse effects by telephone interviews.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Atiye Specialized Rheumatology Center
Full name of responsible person
Mehrzad Hajaliloo
Street address
Atiye building, Golgasht tee, Azadi Street, Tabriz, Eastern-Azarbaijan, Iran
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
Dr. Bahram Pourghasem
Street address
Golbad Street, Tabriz, Eastern-Azarbaijan, Islamic Republic of Iran
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
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences