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Comparison of the effect of Shebet Oil and Diclofenac Gel on clinical symptoms in patients with Knee osteoarthritis: A randomized, double-blind, controlled Clinical trial

Protocol summary

Summary
This is a Double-Blinded Randomized clinical study to compare the effects of herbal Shebet Oil with diclofenac gel on patients with clinical symptoms of knee osteoarthritis. 80 patients according to ACR classification criteria by the rheumatologist, Patient's written consent, Osteophyte in radiography, Knee pain associated with one of these symptoms: (age older than 50 years, following 30 minutes of morning stiffness, Knee Crepitus) in the age range 80-40 years are accepted. They will allocate to two arms using block randomization. Drugs will be encoding, same shape and without the name, 2 grams, three times a day for 4 weeks will prescribe to intervention groups(Both groups). Body weight, Height, CBC, Diff, BUN, Cr, ALT, AST will measure at the beginning time and after 4 weeks just repeated mentioned experiments. Patients two weeks after the start and after 4 weeks of treatment (end of study) are examined by the rheumatologist and the relevant data through interviews and examination of them will be collected.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012055315N1
Registration date: 2011-04-20, 1390/01/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-04-20, 1390/01/31
Registrant information
Name
Mahmood Khodadoost
Name of organization / entity
Iranian Traditional Medicine College
Country
Iran (Islamic Republic of)
Phone
+98 21 4423 4801
Email address
mkhodadoost@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shahed college of Medcine
Expected recruitment start date
2010-07-14, 1389/04/23
Expected recruitment end date
2011-07-14, 1390/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Shebet Oil and Diclofenac Gel on clinical symptoms in patients with Knee osteoarthritis: A randomized, double-blind, controlled Clinical trial
Public title
Effect of Shebet Oil on Knee Arthrosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion critria: Patient's written consent for inclusion, Osteophyte in X.Ray, Knee pain Plus at least one of three: (Age>50 year, Stiffness<30 minutes, Crepitus). Exclusion Critria: Those who need more than 2 grams of acetaminophen ,Those who need to use other oral or intravenous analgesic ,Unwillingness to continue to participate in the study, Sensitivity to study drugs, Patients with other bone joint disorders:(Rhumatoid Arthrities, Gout,Pseudo Gout, Infected Arthrities, Metabolic Arthrities, Traumatic Arthrities), Joint Replacement, fibro Myalgia, Non-motor dysfunction related to hip or knee( Radiculopathy and Neuropathy), Concomitant use of glucosamine and chondrotin sulfate Knee Articular, Knee corticosteroid injection in the past 3 months, Other Articular corticosteroid injection in the past 1 months, Taking muscle relaxant drugs, Pregnancy, Oral and Local use of Corticosteroid in 14 past days, Mussle corticosteroid injection in the past 1 months Alcohol addicted, Drug Abuse, Skin Diseases in Knee, Pationts with active Renal, Liver and Peptic Ulcer Diseases, Low dose Antidepressant user for chronic pain.
Age
From 40 years old to 80 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
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Traditional Medcine College, Tehran University of Medical science
Street address
Traditional Medcine College, Tehran University of Medical science, Farre danesh Alley, Ghods Avenue
City
Tehran
Postal code
1417744391
Approval date
2011-02-15, 1389/11/26
Ethics committee reference number
200/7029

Health conditions studied

1

Description of health condition studied
Arthritis
ICD-10 code
M19
ICD-10 code description
Primary arthrosis of other joints

Primary outcomes

1

Description
Overall patient satisfaction
Timepoint
2 Weeks
Method of measurement
Ask the patient

2

Description
Physical performance
Timepoint
2 Weeks
Method of measurement
Womac Test

3

Description
Stifness
Timepoint
2WEEKS
Method of measurement
womac Test

4

Description
Pain
Timepoint
2 Weeks
Method of measurement
Womac Test

Secondary outcomes

empty

Intervention groups

1

Description
shebet oil. Knee local use. Dosage 2 grams per use 3 times a day. Patients will be visited at the 0, 2, 4 weeks of the study.
Category
Treatment - Drugs

2

Description
Pluse control group: diclofenac gel group. Knee local use. Dosage 2 grams per use 3 times a day. Patients will be visited at the 0, 2, 4 weeks of the study.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mostafa Khomeiny Hospital
Full name of responsible person
Dr.Mahmood Khodadoost
Street address
Italy Avenue, Mostafa Khomeiny Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shahed college of Medcine
Full name of responsible person
Dr.Davati
Street address
Medical college, Abdollah zadah street, keshavarz B.L.V.
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,Shahed college of Medcine
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
Traditional Medcine College
Full name of responsible person
Mahmood Khodadoost
Position
The Asistant of Traditional Medcine
Other areas of specialty/work
Street address
Legal Medicin organization, Behest Avenue, Parke Shar
City
Tehran
Postal code
Phone
+98 21 5560 9071
Fax
Email
mkhodadoost@razi.tums.ac.ir; mkhodadoost2010@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Traditional Medcine College
Full name of responsible person
Mahmood Khodadoost
Position
The Asistant of Traditional Medcine
Other areas of specialty/work
Street address
Legal Medicin organization, Behest Avenue, Parke Shar
City
Tehran
Postal code
Phone
+98 21 5560 9071
Fax
Email
mkhodadoost@razi.tums.ac.ir; mkhodadoost2010@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Traditional Medcine College
Full name of responsible person
Mahmood Khodadoost
Position
The Asistant of Traditional Medcine
Other areas of specialty/work
Street address
Legal Medicin organization, Behest Avenue, Parke Shar
City
Tehran
Postal code
Phone
+98 21 5560 9071
Fax
Email
mkhodadoost@razi.tums.ac.ir; mkhodadoost2010@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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