The effect of chamomile (Matricaria recutita L.) on serum levels of tumor necrosis factor-a (TNF-a), interlukin-1ß and matrix metalloproteinase-3 (MMP3) in rheumatoid arthritis women patients

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2015
INTERVENTION: 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. 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 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. Treatment ‐ Other CONDITION: Rheumatoid arthritis, unspecified Rheumatoid arthritis. ; Rheumatoid arthritis, unspecified PRIMARY OUTCOME: Intelukin 1‐ß (IL‐1ß), Tumor Necrosis Factor‐alpha(TNF‐alpha). Timepoint: At baseline and after 6 weeks of intervention. Method of measurement: ELISA. SECONDARY OUTCOME: Matrix metalloproteinase 3 (MMP‐3). Timepoint: At baseline and after 6 weeks of intervention. Method of measurement: ELISA. INCLUSION 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 interve
Epistemonikos ID: 8ca39e4b10bd4005f9d42e146610510c24952b70
First added on: Mar 24, 2022