comparsion the effects of 3% Cichorium intybus L. hydroalcoholic extract gel vs diclofenac gel in the treatment of patient with primary monoarticular knee osteoarthritis In patients taking celecoxib.
The aim of this study was to determine and compare the therapeutic effects of 3% gel of hydroalcoholic extract of Chicory and diclofenac in the treatment of knee joint primary osteoarthritis. Design: Double-blind, randomized clinical trials with placebo control. Population studied: patients with primary and knee joint osteoarthritis. Entrance criteria: age 80-40, weight 80-50kg, primary knee osteoarthritis, approved by radiological criteria in knee graphy, secondary osteoarthritis or suspicion, lack of liver and kidney disease, or any other underlying illness , Not having a history of allergies and allergies. Exit criteria: Primary osteoarthritis in both knees, skin diseases, or infection or ulcers at the place of topical use of the drug, the use of other topical drugs at the place of use, the use of aromatase inhibitors, oral administration of other analgesics and other Effective compounds in the treatment of osteoarthritis up to 10 days before the start of the study, arthralgia, pregnancy, lack of cooperation and the desire of the individual during the study to continue the company, causing any allergies or any problems during the intervention. Sample size: 150 people. Study Intervention: Salixib tablets are sacrificed 200 mg once a day, and 3% germs of chicory three times a day and each time for 3 to 5 minutes for 6 weeks are rubbed over the target area. Outcomes: The aim of this study was to compare the pain, morning dryness, dry daytime and physical function based on interviews, observation and standard WOMAC and VAS questionnaires in both control and intervention groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017103037093N1
Registration date:2017-11-20, 1396/08/29
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahrekord University of Medical Sciences
Expected recruitment start date
2017-12-03, 1396/09/12
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparsion the effects of 3% Cichorium intybus L. hydroalcoholic extract gel vs diclofenac gel in the treatment of patient with primary monoarticular knee osteoarthritis In patients taking celecoxib.
Public title
Chicory gel effect on the treatment of osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
The criteria for entering the study include: age 80-40, weight 80-50kg, primary osteoarthritis in one knee, confirmed by radiological criteria in knee graphy, secondary osteoarthritis or suspicion, lack of history of cognitive impairment, lack of disease Liver and kidney or any other underlying disease, having no history of allergies and allergies
Exclusion criteria include: primary osteoarthritis in both knees, history of allergy to any form of anti-inflammatory drugs, skin diseases or infection or ulcers at the site of topical use of the drug, the use of other topical drugs at the place of use of the drug, The use of aromatase inhibitors, the oral administration of other analgesics and other compounds effective in the treatment of osteoarthritis up to 10 days before the start of the study, joint arthritis, pregnancy, lack of cooperation and the desire of the individual during the study to continue the company, the creation of any Sensitivity or any problem during the intervention
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:
150
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 of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Postal code
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.SKUMS.REC.1396.154
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis
Primary outcomes
1
Description
Knee pain
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
WOMAC & VAS questionnaire
2
Description
daytime stiffness
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
WOMAC questionnaire
3
Description
Morning stiffness
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
WOMAC questionnaire
4
Description
Physical performance
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
WOMAC questionnaire
Secondary outcomes
1
Description
Skin allergy
Timepoint
Six weeks after the intervention
Method of measurement
Observation and examination
Intervention groups
1
Description
Negative control group: Patients with knee joint primary osteoarthritis who take tablets of 200 mg once a day and gel containing the base of the gel (placebo) three times a day and for 3 to 5 minutes, 6 Weeks rub them over the area.
Category
Placebo
2
Description
Positive control group: Patients with knee primary osteoarthritis who eat tablets of 200 mg once a day, once a day, and 1% diclofenac gel three times a day for 3 to 5 minutes and for 6 weeks rub on the area.
Category
Treatment - Drugs
3
Description
Intervention group: Patients with knee primary osteoarthritis who eat tablets of 200 mg once a day and 3% chicory gel three times a day for 3 to 5 minutes and 6 weeks on the target area They rub.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic office
Full name of responsible person
Dr. Morteza Dehghan (Associate Professor of Orthopedics)
Street address
Ground Floor, Kosar Passage, lower than Water Circle, Southern Moharram Twelve Street
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Sciences
Full name of responsible person
Dr. seyed Kamal Solati(Associate Professor of Psychology)
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
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, Shahrekord University of Medical Sciences
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
Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Position
Orthopedic
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3227 4004
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Position
Orthopedic
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3227 4004
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Morteza Dehghan
Position
Orthopedic
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Postal code
Phone
+98 38 3227 4004
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)