The aim of this study is to evaluate the therapeutic efficacy of traditional medicine product "Linum usitatissimum" seed oil in patients with knee osteoarthritis. First, patients with osteoarthritis of the knee, according to the inclusion criteria approved by orthopedic specialist are recruited. Then the patients are informed about the project and presence of case and control groups and after obtaining the consent; they will be enrolled into the project. Then patients allocated randomly with random block into the two treatment and placebo groups then they receive encoded drug (drug or placebo) and consume it according to the instructions. Patient and physician have no information about the drop content (double-blind randomized clinical trial). After filling the form and questionnaire by the patient, X-rays of the knee is requested (if there is no x-ray in the past 6 months) along with the necessary tests to find patients with severe kidney or liver problems for exclusion criteria, such as CBC, BUN, Cr, AST, ALT. During this period, patients can use up to 3 Tablet of Diclofenac 50mg per day. The "Linum usitatissimum" seed oil will be used topically for a period of 6 weeks every 8 hour with the dosage of 20 drops without massage.The placebo group will receive paraffin oil with same fashion. Patients will be visited at weeks 0, 3 and 6 and fill in the questionnaire at weeks 0, 6.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020726407N1
Registration date:2016-09-15, 1395/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-15, 1395/06/25
Registrant information
Name
Nematollah Masoudi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
nmasoudi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Traditional Medicine and Materia Medica Research Center (TMRC), Shahid Beheshti University of Medical Sciences (Tehran - Iran)
Expected recruitment start date
2016-07-20, 1395/04/30
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of "Linum usitatissimum" Seed topical oil, on Clinical Sign of Knee Osteoarthritis Compared with Placebo, A Double Blind Clinical Trial
Public title
Effect of flaxseed oil on clinical sign of Knee Arthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient between 40 to 70 yaers age with BMI less than 35 that fill clinical and radiologic criteria of ACR and have Kellgren-Lawrence Grading Scale III / II / I, with VAS over than 4 cm; Clinical and radiological criteria of ACR include: knee pain, osteophyte in radiography, plus at least 1 of 3 below criteria: age more than 50 years old; morning stiffness less than 30 minutes; crepitation of knee. Exclusion criteria: Acute arthritis, osteoarthritis due to rheumatologic disease such as RA and gout, infective arthritis, metabolic arthritis, traumatic, uncontrolled diabetes, known case of cardiac or hepatic disease, cancer; History of knee replacement surgery; Fibromyalgia, radiculopathy and neuropathy; Those who are unable to tolerate and complete the study or treatment and follow-up; As well as those who use more than 3 tablets Diclofenac 50mg daily or need other oral or injection form of pain control, are excluded; At the same time, patients with Glucosamine, Chondroitin sulfate, and muscle relaxants use; sensitivity to medicinal plants; History of receiving oral or topical steroids during the 14 days prior to the study; Corticosteroids injection in the period of 30 days before study; pregnancy, hepatorenal active disease, gastritis, addiction to alcohol and narcotic drugs, skin disease of knee, those receiving antidepressant for chronic pain, Also, people who have mild and intermittent pain that only require non-pharmacological recommendations; New forms of therapies such as hydrotherapy, physiotherapy, start to interfere with the study.
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Shahid Beheshti University of Medical Sciences (IR.SBMU.REC
Street address
Office of Research Management, Shahid Beheshti University of Medical Sciences, side of Taleghani Hospital, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
ایران
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.SBMU.REC.1395.2
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis
Primary outcomes
1
Description
pain
Timepoint
At the beginning of intervention and 6 weeks after the beginning of intervention
Method of measurement
KOOS Pain and VAS
Secondary outcomes
1
Description
Knee discomfort
Timepoint
At the beginning of intervention and 6 weeks after the beginning of intervention
Method of measurement
KOOS Scoring
2
Description
Stiffness
Timepoint
At the beginning of intervention and 6 weeks after the beginning of intervention
Method of measurement
KOOS Scoring
3
Description
Activities and daily living
Timepoint
At the beginning of intervention and 6 weeks after the beginning of intervention
Method of measurement
KOOS Scoring
4
Description
Sport and recreation function
Timepoint
At the beginning of intervention and 6 weeks after the beginning of intervention
Method of measurement
KOOS Scoring
5
Description
Quality of life
Timepoint
At the beginning of intervention and 6 weeks after the beginning of intervention
Method of measurement
KOOS Scoring and SF26 WHO
Intervention groups
1
Description
Intervention group: Linum usitatissimum seed topical oil 20 drops every 8 hours without massage for 6 weeks, in case of pain, up to 3 tablets of diclofenac 50 mg is permitted
Category
Treatment - Drugs
2
Description
Control group: placebo; paraffin oil with the same method and order of intervention groups and for 6 weeks, in case of pain, up to 3 tablets of diclofenac 50 mg is permitted
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Shariat Panahi Clinic
Full name of responsible person
Mohammad Kazem Emami meybodi
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Orthopedic Clinic of Bagheiyatallah Hospital
Full name of responsible person
Nematollah Masoudi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Traditional Medicine College of Shahid Beheshti University of Medical S
Full name of responsible person
Dr Mahmood Mosadegh
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
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,Traditional Medicine College of Shahid Beheshti University of Medical S
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
College of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nematollah Masoudi
Position
Ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 2521
Fax
Email
nmasoudi@sbmu.ac.ir; salman.farsy@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Traditional Medicine College of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahmood Khodadoost
Position
Associate Professor
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 2521
Fax
Email
mkhodadoost@LMO.ir; mkhodadoost2010@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
College of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nematollah Masoudi
Position
Ph.D student ofTraditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Tavanir St, Vali Asr St, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
nmasoudi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)