The effect of topical ointment containing Berberis vulgaris' extract versus placebo on the severity of morning stiffness and range of motion in rheumatoid arthritis patients: a double-blind randomized clinical trial
To assess the effect of a topical ointment containing Berberis vulgaris' extract versus placebo on the severity of morning stiffness and range of motion in rheumatoid arthritis patients
Design
This is a double-blind randomized clinical trial, phase II, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible rheumatoid arthritis patients who will refer to Shahid Beheshti Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 60 years,
Rheumatoid arthritis
Exclusion criteria:
Using narcotic substance or alcohol
Intervention groups
Intervention group:
Routine treatment plus using Eucerin-based ointment containing hydroalcoholic Berberis vulgaris' extract at 10% concentration, manufactured by the laboratory of the School of Pharmacy, Hamadan University of Medical Sciences, twice daily for 15 days
Control group:
Routine treatment plus using Eucerin-based ointment without any additional medication, manufactured by the laboratory of the School of Pharmacy, Hamadan University of Medical Sciences, twice daily for 15 days
Main outcome variables
Primary outcome:
The severity of morning stiffness of the joint, the range of motion of the joint
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N310
Registration date:2019-10-18, 1398/07/26
Registration timing:prospective
Last update:2019-10-18, 1398/07/26
Update count:0
Registration date
2019-10-18, 1398/07/26
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical ointment containing Berberis vulgaris' extract versus placebo on the severity of morning stiffness and range of motion in rheumatoid arthritis patients: a double-blind randomized clinical trial
Public title
The effect of topical ointment containing Berberis vulgaris' extract versus placebo on the severity morning stiffness and range of motion in rheumatoid arthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 60 years,
Rheumatoid arthritis
Exclusion criteria:
Using narcotic substance or alcohol
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-08-10, 1398/05/19
Ethics committee reference number
IR.UMSHA.REC.1398.425
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
The severity of morning stiffness of the joint
Timepoint
Before the intervention and 15 days after that
Method of measurement
By Visual Analog Scale (VAS)
2
Description
The range of motion of the joint
Timepoint
Before the intervention and 15 days after that
Method of measurement
By physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus using Eucerin-based ointment containing hydroalcoholic Berberis vulgaris' extract at 10% concentration, manufactured by the laboratory of the School of Pharmacy, Hamadan University of Medical Sciences, twice daily for 15 days
Category
Treatment - Drugs
2
Description
Control group: Routine treatment plus using Eucerin-based ointment without any additional medication, manufactured by the laboratory of the School of Pharmacy, Hamadan University of Medical Sciences, twice daily for 15 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan City
Full name of responsible person
Fatemeh Soleimani
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
Coleimany.neda@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Soleimani
Position
Student of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
Coleimany.neda@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Khodayar Oshvandi
Position
PhD in Nursery
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
oshvandi2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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