Study the Effect of a Fig and Olive Oil Preparation on Remission Indicators of Rheumatoid Arthritis (RA) based on the Iranian Traditional Medicine and the Modern Medicine
This study is a randomized clinical trial in which effect of a combination of olive oil and fig on the remission of the signs and symptoms of patients with RA referred to the outpatient clinic of a teaching hospital (The Loghman Hakim hospital) will be investigated. Patients will be divided into two groups consisting of 29 patients in each group. The first group (control group) will continue the standard treatment of RA i.e. DMARDS and adjunctive agents, while the second group (treatment group) will receive the herbal study preparation (olive oil plus powdered fig suspension) along with the standard therapy of RA. Clinical outcomes and laboratory findings will be measured and recorded for each patient at the beginning (baseline) and every 4 weeks for 16 weeks. The study outcomes are determined based on the traditional medicine literature as well as those recommended by classical medicine guidelines. Study objective is to determine and compare the remission indicators of RA in two study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122015876N1
Registration date:2014-03-03, 1392/12/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-03, 1392/12/12
Registrant information
Name
Shahnaz Bahadori
Name of organization / entity
School of Traditional Medicine
Country
Iran (Islamic Republic of)
Phone
+98 920 301 3768
Email address
bahadorish@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Traditional Medicine, Tehran University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the Effect of a Fig and Olive Oil Preparation on Remission Indicators of Rheumatoid Arthritis (RA) based on the Iranian Traditional Medicine and the Modern Medicine
Public title
Effect of olive oil and fig on Rheumatoid Arthritis (RA)
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 19 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is designed as an add-on therapy, so that one group will receive the standard treatment and the other group will take the study drug plus standard treatment
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Faculty of Traditional Medicine, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2014-01-20, 1392/10/30
Ethics committee reference number
92-01-86-21568-103137
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Primary outcomes
1
Description
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.
2
Description
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
3
Description
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
4
Description
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 outcomes
1
Description
FBS
Timepoint
at the begining of study (baseline) and every 4 weeks for 16 weeks
Method of measurement
lab test
2
Description
lipid profile
Timepoint
at the begining of study (baseline) and every 4 weeks for 16 weeks
Method of measurement
lab test
3
Description
change in the use of NSAIDs (dose or frequency)
Timepoint
during 16 weeks of study
Method of measurement
self-report and doctor's order
4
Description
change in the use of corticosteroids
Timepoint
during 16 weeks ofstudy period
Method of measurement
self-report and doctor's order
5
Description
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
Intervention groups
1
Description
15 ml of the study preparation (olive oil and fig as oral suspension), bd, 16 weeks; along with standards treatment (DMARDs)
Category
Treatment - Drugs
2
Description
Control: standard treatment of RA (DMARDs)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Loghman Hakim Teaching Hospital
Full name of responsible person
Shahnaz Bahadori
Street address
Faculty of Traditional Medicine, Tehran Uni. Med. Sci.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Younesian
Street address
Tehran University of Medical Sciences, Qods st., Kshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of traditional Medicine, Tehran Uni. Med. Sci.
Full name of responsible person
Dr Mohammad Reza Shams Ardekani
Position
PhD of Pharmacognosy, Professor
Other areas of specialty/work
Street address
Faculty of traditional Medicine, Tehran Uni. Med. Sci.
City
Tehran
Postal code
Phone
+98 21 8899 0837
Fax
Email
ardekani@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Jamshid Salamzadeh
Position
PhD of Clinical Pharmacy - Associate Pof.
Other areas of specialty/work
Street address
School of Pharmacy, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8866 2334
Fax
+98 21 8866 2335
Email
j.salamzadeh@sbmu.ac.ir; j.salamzadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Traditional Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Shahnaz Bahadori
Position
Traditional Medicine resident (PhD candidate)
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 4447 6970
Fax
Email
bahadorish@yahoo.com; bahadorish@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)