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IRCT20201126049498N1 IRCT 2021-03-10 Shahed University effect of Melissa officinalis in treatment of patient with Rheumatoid arthritis Pilot evaluation of the anti-inflamation and analgesics effect of oral administration of Melissa officinalis in patients with Rheumatoid arthritis: a double-blind randomized crossover trial 2021-03-06 anticipated 20 Complete https://irct.ir/trial/54482 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we used Random Allocation software for randomization. The random sequence of samples was performed equally as Intervention and Placbo groups using this software. For allocation concealment, sealed envelopes were used. In this method, each of the random sequences written on a card and they is placed in the envelopes, respectively. Finally, the lid of the envelopes is glued and placed in a box, respectively. At the registration time, based on the order in which eligible participants enter the study, one of the envelopes of their choice will be opened and their assigned group will be revealed, Blinding description: Bottles of drugs and placebo were coded by an expert one in the research center. Researchers, patients, data collectors, and evaluators assess the outcome, are not aware of the contents of the package and grouping, and samples were delivered as random double-blind to the patient. Patients received the number to their referral and entered the study. The number of patients was randomly selected by computer and divided into two groups. 2 Rheumatoid arthritis disease. Intervention 1: Melissa officinalis is a perennial herbaceous plant in the mint family (Lamiaceae). Scientific research of this plant shows that it has anti-inflammatory, analgesic, and anti-depressant effects. Dried M. officinalis leaves after powdering in the mill, were administered to patients as 500 mg capsules twice a day (once every 12 hours) for 8 weeks. Intervention 2: Control group: Ready bread crumbs without any additives, were administered to patients as 500 mg capsules twice a day (once every 12 hours) for 8 weeks. Yes - There is a plan to make this available What will be shared: All impersonal data of the participants without any name; Information on the main implications and all the information obtained from the research were published in article. When: In the relevant article after its publication To whom: Everyone who has access to the published article Conditions: After publication in the journal Where to obtain: Article and Dr Azadeh Mizani as the main researcher azadeh.mizani@yahoo.com How to obtain: An email to that person Comments:
public Azadeh Mizani
Floor 2, No. 1471, North Kargar Ave, Enghelab Sq, Traditional medicine clinical trial Research Center, Shahed University
Tehran Iran (Islamic Republic of) 1417953836 +98 21 6641 8331 azadeh.mizani@yahoo.com Shahed University scientific Abdolrahman Rostamian
Imam Khomeini Hospital Complex, Qarib Avenue, the end of Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6691 1294 ar.rostamian@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patient satisfaction and signing of informed consent form Diagnosis of patients with moderate Rheumatoid Arthritis Using the Criteria of the American College of Rheumatology Patients over 18 years During the period of the disease up to 15 years DAS Score between 3-5 18 years no limit Both Lack of cooperation of patients History of Heart, kidney, liver and ... diseases Pregnancy Any kind of Immunodeficiency diseases No other autoimmune diseases M06.9 Rheumatoid arthritis, unspecified Treatment - Drugs Placebo Melissa officinalis is a perennial herbaceous plant in the mint family (Lamiaceae). Scientific research of this plant shows that it has anti-inflammatory, analgesic, and anti-depressant effects. Dried M. officinalis leaves after powdering in the mill, were administered to patients as 500 mg capsules twice a day (once every 12 hours) for 8 weeks. Control group: Ready bread crumbs without any additives, were administered to patients as 500 mg capsules twice a day (once every 12 hours) for 8 weeks. Evaluation of Disease Activity Score 28 (DAS 28). Timepoint: 2 months after and before treatment. Method of measurement: DAS Calculator software. Evaluation of ESR (Erythrocyte Sedimentation Rate. Timepoint: 2 months after and before treatment. Method of measurement: Using Westergren method. Evaluation of Rheumatoid Factor (RF). Timepoint: 2 months after and before treatment. Method of measurement: Quantitative method with diagnostic kit. Evaluation of CRP (C-Reactive Protein). Timepoint: 2 months after and before treatment. Method of measurement: Quantitative method with diagnostic kit. Evaluation of Anti ccp (Cyclic Citrirullinated Peptide). Timepoint: Before treatment. Method of measurement: ELISA method. Assay of TNF-α (Tumor necrosis factor α). Timepoint: 2 months after and before treatment. Method of measurement: ELISA method. Assay of Interleukin 17 (IL-17). Timepoint: 2 months after and before treatment. Method of measurement: ELISA method. ٍEvaluation of visual analog scale (VAS). Timepoint: 2 months after and before treatment. Method of measurement: Questionnaire. Evaluation of World Health Organization Quality of Life-BREF (WHOQOL-BREF). Timepoint: 2 months after and before treatment. Method of measurement: Questionnaire. Evaluation of Beck Depression Inventory (BDI-II). Timepoint: 2 months after and before treatment. Method of measurement: Questionnaire. Shahed University Approved 2018-10-29 Shahed University Committee for Ethics in biomedical Research Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway Tehran Tehran Iran (Islamic Republic of)