Investigating the clinical effects of a herbal formulation in relieving inflammation and joint pains in patients with osteoarthritis
Design
In this study, 60 patients with osteoarthritis that referred to the Imam Reza clinic will be selected based on the inclusion criteria and randomly divided into intervention and control groups. Each participant will be assigned a unique code.
Settings and conduct
This study, which will be carried out at the Imam Reza clinic in Kermanshah city, is double blinded and investigators and patients will be kept blinded to taking medication or placebo. At the beginning of the study, pain and joints stiffness in both groups will be recorded in a checklist
Participants/Inclusion and exclusion criteria
Inclusion criteria : Over 50 years old; No change in medication and treatment regimen in the last three months.
Exclusion criteria: Pregnant women; women who intend to be pregnant; and lactating women; Addicted people (natural, synthetic or alcoholic drugs)
Intervention groups
The intervention group will receive the herbal medicine every night in the form of a topical cream in an approximate amount of two grams by rub on knee joint for one month.
The control group, will receive the placebo every night in the form of a topical cream in an approximate amount of two grams by rub on knee joint for one month.
Main outcome variables
Joint pain; joints stiffness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131219015870N2
Registration date:2018-01-07, 1396/10/17
Registration timing:prospective
Last update:2018-01-07, 1396/10/17
Update count:0
Registration date
2018-01-07, 1396/10/17
Registrant information
Name
Amir Kiani
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6482
Email address
akiani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
kermanshah University of Medical Sciences(KUMS)
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical effects of a herbal formulation in relieving inflammation and joint pains in patients with osteoarthritis
Public title
Clinical effects of a herbal formulation in relieving inflammation and joint pains
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Average age over 50 years
During the last three months, the type and regimen of the medication and treatment used for the patient have not changed.
Patients who have injected hyaluronic acid
Exclusion criteria:
Patients who have other diseases or use other medications
Pregnant women, women who intend to have a pregnancy and breast-feeding women
Addicted people (natural, synthetic or alcoholic drugs)
Patients who will get another illness during treatment or be forced to use another drug
Age
From 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the investigator and patients will be kept blind to taking medication or placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
KUMS.REC.1395.505
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
Primary outcomes
1
Description
joint pain
Timepoint
At the beginning of the study and the end of the study (one month later)
Method of measurement
Using the The Western Ontario and McMaster Universities Osteoarthritis questionnaire (WOMAC)
2
Description
Dryness of the joint
Timepoint
At the beginning of the study and the end of the study (one month later)
Method of measurement
Using the The Western Ontario and McMaster Universities Osteoarthritis questionnaire (WOMAC)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive the herbal medicine every night in the form of a topical cream in an approximate amount of two grams by rub on knee joint for one month
Category
Treatment - Drugs
2
Description
The control group, will receive the placebo every night in the form of a topical cream in an approximate amount of two grams by rub on knee joint for one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
KUMS
Full name of responsible person
Amir kiani
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
akiani@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Kermanshah University of Medical Sciences
Full name of responsible person
Elham Choolaki
Position
Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Fax
Email
elhamchoolaki@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Kiani
Position
Faculty Member of Medical University
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Shahid Shiroodi Blvd., Faculty of Pharmacy
City
Kermansha
Province
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6489
Fax
+98 83 3427 6493
Email
akiani@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Elham Choolaki
Position
Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Fax
+98 83 3427 6493
Email
elhamchoolaki@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
En Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
En In a 15-day period, the documents will be sent e-mail