Rheumatoid Arthritis.
Conditions
Interventions
Intervention 1: 15 ml of the study preparation (olive oil and fig as oral suspension), bd, 16 weeks
along with standards treatment (DMARDs). Intervention 2: Control: standard treatment of RA (DMARDs).
Treatment - Drugs
15 ml of the study preparation (olive oil and fig as oral suspension), bd, 16 weeks
along with standards treatment (DMARDs)
Control: standard treatment of RA (DMARDs)
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
19 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: male and female patients with active RA who has a DAS-28 of minimum 2.6; age over 18 years old; patients on standard DMARDS therapy and adjunctive agents; not receiving biologic DMARDS in the past 6 months. Exclusion criteria: patients with concurrent rheumatoid diseases or gout; patients with uncontrolled Diabetes Mellitus; patients with a major change in their ordinary diet; patients receiving other traditional medicine therapies during study period; i. pregnancy; patients with a history of continuous fig and olive oil consumption in the last 3 months; history of inter-articular injection of corticosteroids in the last 3 months as well as during the study period; any kind of addiction or drug abuse; occurrence of severe adverse reactions due to intervention; patient unwillingness to fulfill the study; patient non-compliance on regular use of the study medicine defined as >20% non-adherence in taking the study drug.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28-ESR. Timepoint: at the begining of study (baseline) and every 4 weeks for 16 weeks. Method of measurement: Number of tender joints, Number of swellen joints, ESR values, patient self-assessment of the disease. These data will be entered the specific formula to calculate the DAS28-ESR.;Urine color (as a traditional medicine outcome). Timepoint: at the begining of study (baseline) and every 4 weeks for 16 weeks. Method of measurement: qualitative observation of the urine color using traditional medicine criteria.;Urine viscosity. Timepoint: at the begining of study (baseline) and every 4 weeks for 16 weeks. Method of measurement: observation of the urine based on the traditional medicine criteria.;Joints Pain. Timepoint: at the begining of study (baseline) and every 4 weeks for 16 weeks. Method of measurement: number of paifull joints and its severity using VAS scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| FBS. Timepoint: at the begining of study (baseline) and every 4 weeks for 16 weeks. Method of measurement: lab test.;Lipid profile. Timepoint: at the begining of study (baseline) and every 4 weeks for 16 weeks. Method of measurement: lab test.;Change in the use of NSAIDs (dose or frequency). Timepoint: during 16 weeks of study. Method of measurement: self-report and doctor's order.;Change in the use of corticosteroids. Timepoint: during 16 weeks ofstudy period. Method of measurement: self-report and doctor's order.;Possible adverse reaction of diarrhea. Timepoint: monitoring over the study period. Method of measurement: self-report and medical history of patient taken every 4 weeks. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Mohammad Reza Shams Ardekani
Faculty of traditional Medicine, Tehran Uni. Med. Sci.
Outcome results
None listed