Determining the effect of Elaeagnus angustifolia stone on the severity of menopausal osteoarthritis pain
Design
Clinical trial with control and placebo group, with parallel, double-blind, randomized, phase 3 groups on 160 patients.
Settings and conduct
This study was performed on outpatients referred to the clinic of Sabzevar Emdad Hospital. Patients in the control group received the usual drug treatment with capsules containing medicinal starch (placebo), which was similar in shape and color to the capsules of the intervention group, twice a day for 8 weeks. Patients in the intervention group were treated with 200 mg capsules of Elaeagnus angustifolia stone powder twice a day in addition to the usual medications for at least 8 weeks. Patients' pain intensity was assessed before, 4 weeks and 8 weeks after receiving the drug or placebo. Patients and researchers do not know which patient will be in which group (intervention or placebo).
Participants/Inclusion and exclusion criteria
inclusion Criteria: Menopausal patients aged 40-80 who have osteoarthritis according to the clinical and radiological criteria of the American College of Rheumatology.
In active movements of the knee, they experience pain (at least 40 mm according to the VAS standard) and have back pain.
Exclusion Criteria: Diseases of the spine or factors that lead to aggravation of knee pain.
Intervention groups
Elaeagnus angustifolia stone group, Elaeagnus angustifolia fruit powder, placebo and routin drug control group
Main outcome variables
osteoarthritis pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180122038472N1
Registration date:2020-07-22, 1399/05/01
Registration timing:retrospective
Last update:2020-07-22, 1399/05/01
Update count:0
Registration date
2020-07-22, 1399/05/01
Registrant information
Name
roya akbarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8353
Email address
akbarzader@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-07, 1396/06/16
Expected recruitment end date
2018-09-20, 1397/06/29
Actual recruitment start date
2017-09-07, 1396/06/16
Actual recruitment end date
2019-01-14, 1397/10/24
Trial completion date
2019-01-14, 1397/10/24
Scientific title
The effect of the Elaeagnus angustifolia stone on osteoarthritis pain severity in postmenopausal women
Public title
Sanjad's effect on osteoporotic pain in menopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal patients aged 40-80 years. who have osteoarthritis according to the clinical and radiological criteria of the American College of Rheumatology.
In active movements of the knee, they experience pain (40 mm from the criterion of 100 mm VAS) and have back pain.
Back pain
Exclusion criteria:
Musculoskeletal disorders
uncontrolled hypertension
receiving steroids
diabetes
Body mass index greater than or equal to 30
Hysterectomy and ovarectomy
class 3 and 4 heart disease
hyperthyroidism
Age
From 40 years old to 80 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
160
Actual sample size reached:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are placed in one of the two groups by simple randomization method with the help of random number table, receive a special code and receive the intervention of the same group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the researcher are kept blind. Coding is done. Medication and placebo are similar capsules that are in the same container.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Bolvar ُSohadaye Hastehie
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2017-03-14, 1395/12/24
Ethics committee reference number
IR.MEDSAB.REC.1395.150
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
severity of pain
Timepoint
Before research, after 4 and 8 weeks
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients referred to the clinic of Sabzevar Emdad Hospital with inclusion criteria were selected. In the daily intervention group, two 200 mg capsules containing Elm kernel prepared by Barij Essence Pharmaceutical Company were given at Kashan University, Kashan School of Pharmacy for 8 weeks. The patient's pain was measured before the intervention, during and at the end of the study with VAS scale (100 mm).
Category
Placebo
2
Description
Control group: two capsules containing starch (similar in shape and color to Elaeagnus angustifolia stone capsules), prepared by Barij Essence Pharmaceutical Company at Kashan University, Kashan University of Pharmacy, were given for 8 weeks. The patient's pain was measured before the intervention, during and at the end of the study with VAS scale.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Emdad Hospital
Full name of responsible person
Nasin Fazel
Street address
Sabzevar Emdad Hospital, Razi Street, Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 58 4464 0115
Email
shohreh1368@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
, Sabzevar University of Medical Sciences, Shohadaye Hasehie Bolvar, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8319
Email
drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Roya Akbarzadeh
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sabzevar University of Medical Sciences, Shohadaye Hastehei Bolvar, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8328
Email
roakbarzadeh53@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Nasrin Fazel
Position
Faculty Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Sabzevar University of Medical Sciences, Shohadaye Hastehie Bolvar, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8317
Email
shohreh1368@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Roya Akbarzadeh
Position
Faculty Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sabzevar University of Medical Sciences, Shohadaye Hastehie Bolvar, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 58 4401 8328
Email
roakbarzadeh53@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