]>
IRCT20180212038705N3 IRCT 2018-07-24 Ahvaz University of Medical Sciences Effect of Grapex on patients with Rheumatoid Arthritis Effect of Grape seed (Grapex medicine) on improvement and relief of disease activity and severity in patients with Rheumatoid Arthritis 2017-12-11 anticipated 60 Complete https://irct.ir/trial/32672 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned into two groups. Assignment of patients to the study groups was done by block randomization method using four blocks, Blinding description: The patients were unaware of the drug they were receiving (Grapex or placebo). Also the experimenters did not know about type of treatment and patient grouping and thus until the end of trial the study remained double-blinded. N/A Rheumatoid arthritis. Intervention 1: Intervention group: Grapex 100 mg daily. Intervention 2: Control group: placebo 100 mg daily. 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 more information.
public Dr. Elham Rajaee
Golestan Hospital, Farvardin Ave., Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3001 elhamrj@gmail.com Ahvaz University of Medical Sciences scientific Dr. Elham Rajaee
Golestan Hospital, Farvardin Ave., Golestan
Ahvaz Iran (Islamic Republic of) 6135733118 +98 61 3374 3001 elhamrj@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Consent to participate in the study Patients with rheumatoid arthritis based on ACR 2010 criteria Moderate to severe disease activity based on Modified DAS28 score 18 years no limit Both Duration of diseases more than 5 years Concomitant use of warfarin Allergy to grapes and its components, Presence of any types of malignancy and cancer Pregnancy M06.9 Rheumatoid arthritis, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Grapex 100 mg daily Control group: placebo 100 mg daily Disease severity. Timepoint: At baseline and after treatment (8 week). Method of measurement: Modified DAS28 score. Erythrocyte sedimentation rate (ESR). Timepoint: At baseline and after treatment. Method of measurement: Western Green analysis. Swollen joint count (SJC). Timepoint: At baseline and after treatment. Method of measurement: Examination and clinical judgment of the physician. Tender joint count (TJC). Timepoint: At baseline and after treatment. Method of measurement: Examination and clinical judgment of the physician. CRP. Timepoint: At baseline and after treatment. Method of measurement: Aagglutination test. Ahvaz University of Medical Sciences Approved 2017-10-04 Ethics committee of Ahvaz Jundishapur university of medical sciences Jundishapur university of medical sciences, Golestan Blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)