Study of the effect of Grape seed (Grapex) on improvement and relief of disease activity and severity in patients with Rheumatoid Arthritis
Design
This is a controlled double-blind clinical trial study conducted on 60 patients with Rheumatoid arthritis. Patients (N= 30 per group) were randomly treated with Grapex or placebo for 8 weeks.
Settings and conduct
This clinical trial study was conducted on 60 rheumatoid arthritis patients with moderate to severe disease activity referring to Golestan Hospital in Ahvaz in 2017-18. Patients were randomly treated with Grapex (100 mg daily) or placebo (100 mg daily) for 8 weeks. The disease activity and severity was evaluated base on Modified DAS28 score.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 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; Exclusion criteria: Duration of diseases more than 5 years, concomitant use of warfarin, allergy to grapes and its components, presence of any type of malignancy and cancer, pregnancy.
Intervention groups
Treatment with Grapex (100 mg) or placebo
Main outcome variables
Activity and severity of disease, ESR and CRP, tender joint count (TJC), swollen joint count (SJC)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180212038705N3
Registration date:2018-07-24, 1397/05/02
Registration timing:retrospective
Last update:2018-07-24, 1397/05/02
Update count:0
Registration date
2018-07-24, 1397/05/02
Registrant information
Name
Fariba Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 2242
Email address
heidari.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
2017-12-16, 1396/09/25
Actual recruitment end date
2018-03-11, 1396/12/20
Trial completion date
empty
Scientific title
Effect of Grape seed (Grapex medicine) on improvement and relief of disease activity and severity in patients with Rheumatoid Arthritis
Public title
Effect of Grapex on patients with Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur university of medical sciences
Street address
Jundishapur university of medical sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-10-04, 1396/07/12
Ethics committee reference number
IR.AJUMS.REC.1396.893
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Disease severity
Timepoint
At baseline and after treatment (8 week)
Method of measurement
Modified DAS28 score
2
Description
Erythrocyte sedimentation rate (ESR)
Timepoint
At baseline and after treatment
Method of measurement
Western Green analysis
3
Description
Swollen joint count (SJC)
Timepoint
At baseline and after treatment
Method of measurement
Examination and clinical judgment of the physician
4
Description
Tender joint count (TJC)
Timepoint
At baseline and after treatment
Method of measurement
Examination and clinical judgment of the physician
5
Description
CRP
Timepoint
At baseline and after treatment
Method of measurement
Aagglutination test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Grapex 100 mg daily
Category
Treatment - Drugs
2
Description
Control group: placebo 100 mg daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Elham Rajaee
Street address
Golestan Hospital, Farvardin Ave., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
elhamrj@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
Jundishapur University of Medical Sciences, Golestan Bldv.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
badavim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Elham Rajaee
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Golestan Hospital, Farvardin Ave., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
elhamrj@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Elham Rajaee
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Golestan Hospital, Farvardin Ave., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
elhamrj@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ddaruish Mokaramian
Position
Internal Medicine Residency
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Jundishapur University of Medical Sciences, Golestan Bldv.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3013
Email
daruishmokaramian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available