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IRCT2015010111335N4 IRCT 2015-01-28 Vice Chancellor for Research, Tabriz University of Medical Sciences 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 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 2014-12-01 anticipated 44 Complete https://irct.ir/trial/11601 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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. N/A Rheumatoid arthritis. Intervention 1: 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. Intervention 2: 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.
public Dr. Saeed Pirouzpanah
Attar Neyshaboori Street, Golgasht Street, Tabriz, Eastern-Azarbaijan, iran
Tabriz Iran (Islamic Republic of) +98 41 3335 7580 pirouzpanahs@tbzmed.ac.ir Faculty of Nutrition, Tabriz University of Medical Sciences scientific Dr. Soltan-Ali Mahboob and Dr. Saeed Pirouzpanah
Attar Neyshaboori Street, Golgasht Street, Tabriz, Eastern-Azarbaijan, iran
Tabriz Iran (Islamic Republic of) Iran +98 41 3335 7580 Dr_mahboob@hotmail.com; Pirouzpanahs@tbzmed.ac.ir Faculty of Nutrition, Tabriz University of Medical Sciences Iran (Islamic Republic of) 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. 20 years 65 years Female M06.9 Rheumatoid arthritis, unspecified Treatment - Other Placebo 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. 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. Intelukin 1-β (IL-1ß), Tumor Necrosis Factor-alpha(TNF-alpha). Timepoint: At baseline and after 6 weeks of intervention. Method of measurement: ELISA. Matrix metalloproteinase 3 (MMP-3). Timepoint: At baseline and after 6 weeks of intervention. Method of measurement: ELISA. Vice Chancellor for Research, Tabriz University of Medical Sciences Approved 2014-09-06 Ethics Committee, Tabriz University of Medical Science Golbad Street, Tabriz, Eastern Azarbaijan, Islamic Republic Of Iran Tabriz Iran (Islamic Republic of)