Protocol summary

Study aim
Investigating the topical effect of Joint cream (A production of Traditional Iranian Medicine) on the Outcome of Pain and Function in Patients with Knee Osteoarthritis
Design
The first group runs the usual program for the treatment of osteoarthritis (including patient education, exercise, weight loss, Using insoles, physiotherapy, and medication use). The second group, in addition to the usual program of treatment for osteoarthritis (described above), also uses topical arthritis cream (Persian medicine product). The study is a clinical trial with a controlled and randomized control group. Meanwhile, the study is not blind and is done in Phase 3. The sample size is defined as 40 pathent (20 pathent per group).
Settings and conduct
Individuals after obtaining consent to participate in this study are divided into two groups of 20 A and B by stratified balanced block randomization.Then, in both groups, two questionnaires including visual analog scale and KOOS were used to assess pain and function before and after the intervention. Also, 6MWT, Timed up and go test and 30 second chair stand tests were evaluated for performance evaluation in these patients. The patient in A group runs the usual program for the treatment of osteoarthritis (including patient education, exercise, weight loss, Using insoles, physiotherapy, and medication use).The patient in B group, in addition to the usual program of treatment for osteoarthritis (described above), also uses topical arthritis cream (Persian medicine product).The method of using the product (daily at two times in the morning and night) is merely rubbing the cream on the knee joint without massage. Both groups were reassessed 2 times, 4 and 8 weeks after the onset of the course, and both groups completed again the visual analog score and KOOs questionnaires. Both groups A and B are evaluated based on the comparison of two questionnaires before and after the intervention in terms of pain relief and increased performance. This study was carried out in Sport Medicine Clinic of Tehran University of Medical Sciences in Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
Entry requirements: Age over 40 years Having diagnostic criteria for knee osteoarthritis (defined by the American College of Rheumatology) Having grade 2 or 3 osteoarthritis according to radiological criteria Having a BMI of 20-35 Non-arrival conditions: History of rheumatoid arthritis History of knee or hip replacement surgery in the affected joint History of any lower limb surgery over the past 6 months History of intra-articular corticosteroid injection in the last 6 months History of intra-articular injection of gel and PRP in the last year The onset of opioid analgesics or oral corticosteroids over the past four weeks
Intervention groups
The first group runs the usual program for the treatment of osteoarthritis (including patient education, exercise, weight loss, Using insoles, physiotherapy, and medication use). The second group, in addition to the usual program of treatment for osteoarthritis (described above), also uses topical arthritis cream (Persian medicine product).
Main outcome variables
The Effect of Local use of Joints cream (Persian medicine product) on pain and function in patients with knee osteoarthritis.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150613022689N6
Registration date: 2018-03-19, 1396/12/28
Registration timing: prospective

Last update: 2018-03-19, 1396/12/28
Update count: 0
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Ebrahim Khadem Azghadi
Name of organization / entity
School of Traditional Medicine Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6675 4152
Email address
dr.ebrahimkhadem@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the topical effectiveness of Joint‘s cream (A production of Iranian Traditional Medicine - ITM) on pain and function in patients with Osteoarthritis of the knee.
Public title
Examining the topical effectiveness of Joint‘s cream on patients with Osteoarthritis of the knee.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 40 years Having diagnostic criteria for knee osteoarthritis (defined by the American College of Rheumatology) Having grade 2 or 3 osteoarthritis according to radiological criteria Having a BMI of 20-35
Exclusion criteria:
History of rheumatoid arthritis History of knee or hip replacement surgery in the affected joint History of any lower limb surgery over the past 6 months History of intra-articular corticosteroid injection in the last 6 months History of intra-articular injection of gel and PRP in the last year The onset of opioid analgesics or oral corticosteroids over the past four weeks
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals after obtaining consent to participate in this research are divided by method stratified balanced block randomization; Into two groups (A and B) with 20 people in every group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Tehran university of medical sciences
Street address
Sixth floor, , central building of the Tehran university of medical sciences , Ghods street , Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2336

Health conditions studied

1

Description of health condition studied
Osteoarthritis of the knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Pain
Timepoint
At the beginning of the study (before intervention), 4 and 8 weeks after the use of joint cream.
Method of measurement
Using visual analog scale and KOOS questionnaires

2

Description
Function
Timepoint
At the beginning of the study (before intervention), 4 and 8 weeks after the use of joint cream.
Method of measurement
Using visual analog scale and KOOS questionnaires

Secondary outcomes

1

Description
Localized swelling
Timepoint
At the beginning of the study (before intervention), 4 and 8 weeks after the use of joint cream.
Method of measurement
Using visual analog scale and KOOS questionnaires and 6MWT, Timed up and go test tests and 30 second chair stand test.

2

Description
Range of knee joint movements
Timepoint
At the beginning of the study (before intervention), 4 and 8 weeks after the use of joint cream.
Method of measurement
Using visual analog scale and KOOS questionnaires and 6MWT, Timed up and go test tests and 30 second chair stand test.

3

Description
Life satisfaction
Timepoint
At the beginning of the study (before intervention), 4 and 8 weeks after the use of joint cream.
Method of measurement
Using visual analog scale and KOOS questionnaires and 6MWT, Timed up and go test tests and 30 second chair stand test.

Intervention groups

1

Description
Control group: Patients in the control group perform the usual program of treatment for osteoarthritis (including patient education, exercise, weight loss, use insoles, physiotherapy, and medication use).
Category
Treatment - Other

2

Description
Intervention group: Patients in the intervention group also use topical arthritis cream (Persian medicine product) in addition to the usual program for the treatment of osteoarthritis (including patient education, exercise, weight loss, use insoles, physiotherapy and the use of medications).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports medicine clinic of Imam Khomeini hospital
Full name of responsible person
Tohid Seif Barghi
Street address
Imam Khomeini hospital complex ,the end of Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9010
Email
tohid_seif@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
dr.Sahraeian
Street address
At the beginning of Ghods Street, Keshavarz Blvd;Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
ekhadem@tums.ac.ir
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
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
Tehran University of Medical Sciences
Full name of responsible person
Ebrahim Khadem Azghadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sarparast Ave; Taleghani St, Faculty of Persian medicine; Tehran University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6675 4167
Fax
+98 21 6675 4170
Email
ekhadem@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tohid Seif Barghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports medicine clinic , Imam Khomeini hospital complex , the end of Keshavarz blvd; Tehran; Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 61190
Fax
Email
tohid_seif@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ebrahim Khadem Azghadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sarparast Ave; Taleghani St, Faculty of Persian medicine; Tehran University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6675 4167
Fax
+98 21 6675 4170
Email
ekhadem@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The total potential data can be shared after unidentifiable patients.
When the data will become available and for how long
Starting the access period is 6 months after printing the results.
To whom data/document is available
Researchers working in academic and academic institutions as well as those involved in related industries.
Under which criteria data/document could be used
For use in similar scientific studies as well as related pharmaceutical industries.
From where data/document is obtainable
Dr e.khadem Contact number: 09123054043 E-mail address: ekhadem@tums.ac.ir
What processes are involved for a request to access data/document
In agreement with the contact number or e-mail address mentioned, the announcement of the data or documentation used will be made available to the applicant.
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