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IRCT20210630051742N1 IRCT 2021-11-13 Mashhad University of Medical Sciences The effect of sea buckthorn on clinical symptoms of rheumatoid arthritis A clinical trial of comparing the effect of sea buckthorn extract with placebo on clinical symptoms of patients with rheumatoid arthritis 2021-12-22 anticipated 30 Complete https://irct.ir/trial/57318 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization: A simple randomization method that uses a table of random numbers or computer methods to place people in the control or intervention group. Unit of randomization: Individual Tools used in randomization: Table of random numbers by using of randomization.com. allocation concealment: Sealed envelops, Blinding description: In this Triple-blind study, capsules will be similar, and neither patients nor researchers nor analyzers know the type of capsule (Placebo/Sea buckthorn) received. 3 Rheumatoid arthritis. Intervention 1: Intervention group: 500 milligram capsule of sea buckthorn extract, once daily, up to 90 days, manufactured in School of Persian and complementary medicine of Mashhad university of medical sciences. Intervention 2: Control group: Placebo capsule, once daily, up to 90 days, manufactured in School of Persian and complementary medicine of Mashhad university of medical sciences. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Roshanak Salari
Azadi square, university campus, School of Persian and complementary medicine
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 8930 Salarir@mums.ac.ir Mashhad University of Medical Sciences scientific Dr.Roshanak Salari
Azadi square, university campus, School of Persian and complementary medicine
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 8930 salarir@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Newly diagnosed patient based on ACR/EULAER criteria for rheumatoid arthritis. Patient who has received no medication for rheumatoid arthritis until now. Disease severity should be between 2.5 to 5.5 based on DAS criteria. 18 years 50 years Both Patient MI history Patient has hyperlipidemia Patient has liver or kidney impaired function. Patient has any neoplasm Patient has psychiatric diseases. There is active infection in patient's body. Patient takes vitamin/mineral supplements. Patient takes medications like thyroid hormones, Anti hypertensives, contraceptives, diuretics and beta-blockers. Patient drinks alcohol or smokes. Patient has any allergy to sea buckthorn. Patient is pregnant or breastfeeds. Disease severity is above 5.5 based on DAS criteria. M05 Rheumatoid arthritis with rheumatoid factor Treatment - Drugs Placebo Intervention group: 500 milligram capsule of sea buckthorn extract, once daily, up to 90 days, manufactured in School of Persian and complementary medicine of Mashhad university of medical sciences Control group: Placebo capsule, once daily, up to 90 days, manufactured in School of Persian and complementary medicine of Mashhad university of medical sciences Severity of pain. Timepoint: before intervention and 30, 45, 90 days after intervention. Method of measurement: visual analog scale. Number of tender joints. Timepoint: before intervention and 30, 45, 90 days after intervention. Method of measurement: Disease Activity Score Calculator for Rheumatoid Arthritis. Number of swollen joints. Timepoint: before intervention and 30, 45, 90 days after intervention. Method of measurement: Disease Activity Score Calculator for Rheumatoid Arthritis. ESR. Timepoint: Before intervention and 90 days after intervention. Method of measurement: Blood test. Mashhad University of Medical Sciences Approved 2021-06-19 Ethics committee of Mashhad University of Medical Sciences Khorasan Razavi, Mashhad, Doctora intersection, Ghorashi building Mashhad Razavi Khorasan Iran (Islamic Republic of)