Protocol summary
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Study aim
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Determine and compare the therapeutic effects of 3% gel of hydroalcoholic extract of Chicory and diclofenac in the treatment of knee joint primary osteoarthritis.
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Design
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Double-blind randomized clinical trial with parallel and control group
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Settings and conduct
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This study was performed on 150 patients with knee osteoarthritis referred to the orthopedic clinic. The patients were randomly distributed by selecting a card in one of 3 groups A, B, and C. The groups were identical in terms of age, gender and weight, and the patients and the researcher were unaware of the contents of the gel tubes. After 6 weeks of using the medications, the information was re-collected and compared with other groups and with the information before the start of the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age of 40-80 years, weight of 50-810 kgs, primary knee osteoarthritis approved by radiological criteria in knee graphy, secondary osteoarthritis or suspecting to it, lack of liver and kidney disease or any other underlying illness, Not having a history of allergies
Exclusion criteria: Primary osteoarthritis in both knees, Skin diseases or infection or ulcers at the place of topical use of the drug, Use of other topical drugs at the area, 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
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Intervention groups
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Patients were divided into 3 groups receiving diclofenac and hydroalcoholic extract of chicory and placebo gel in addition to receiving celecoxib capsule.
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Main outcome variables
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Physical function; Knee pain; Morning stiffness; Daytime stiffness
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017103037093N1
Registration date:
2017-11-20, 1396/08/29
Registration timing:
prospective
Last update:
2019-04-07, 1398/01/18
Update count:
1
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Registration date
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2017-11-20, 1396/08/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Shahrekord University of Medical Sciences
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Expected recruitment start date
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2017-12-03, 1396/09/12
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Expected recruitment end date
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2018-03-21, 1397/01/01
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Actual recruitment start date
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2017-12-11, 1396/09/20
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Actual recruitment end date
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2019-01-10, 1397/10/20
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Trial completion date
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2019-02-14, 1397/11/25
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Scientific title
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comparsion of the effects of 3% Cichorium intybus L. hydroalcoholic extract gel vs diclofenac gel in the treatment of patients with primary monoarticular knee osteoarthritis who are taking celecoxib.
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Public title
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Chicory gel effect on the treatment of osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
age of 40-80 years
weight of 50-80 kgs
primary osteoarthritis in one knee, confirmed by radiological criteria in knee graphy
secondary osteoarthritis or suspecting to it
lack of history of cognitive impairment
lack of Liver,kidney or any other underlying disease
having no history of allergies
Exclusion criteria:
primary osteoarthritis in both knees
history of allergy to any form of anti-inflammatory drugs
skin diseases,infection or ulcers at the site of topical use of the drug
use of other topical drugs at the place of use of the drug
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
congenital joint diseases
pregnancy
lack of cooperation and desire of the individual during the study to continue the company
creation of any Sensitivity or any problem during the intervention
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Age
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From 40 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
150
Actual sample size reached:
144
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization was done using random numbers table and statistical software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The gel tubes were prepared by the pharmacist and were labeled A, B, and C. None of the patients and researchers knew about their content.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-29, 1396/08/07
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Ethics committee reference number
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IR.SKUMS.REC.1396.154
Health conditions studied
1
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Description of health condition studied
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Knee osteoarthritis
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ICD-10 code
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M17.1
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ICD-10 code description
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Other primary gonarthrosis
Primary outcomes
1
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Description
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Knee pain
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Timepoint
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Before intervention, 6 weeks after intervention
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Method of measurement
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Western Ontario & McMaster Universities Osteoarthritis Index & Visual Analogue Scale questionnaire
2
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Description
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daytime stiffness
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Timepoint
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Before intervention, 6 weeks after intervention
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Method of measurement
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Western Ontario & McMaster Universities Osteoarthritis Index questionnaire
3
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Description
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Morning stiffness
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Timepoint
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Before intervention, 6 weeks after intervention
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Method of measurement
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Western Ontario & McMaster Universities Osteoarthritis Index questionnaire
4
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Description
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Physical performance
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Timepoint
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Before intervention, 6 weeks after intervention
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Method of measurement
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Western Ontario & McMaster Universities Osteoarthritis Index questionnaire
Secondary outcomes
1
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Description
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Skin allergy
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Timepoint
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Six weeks after the intervention
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Method of measurement
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Observation and examination
Intervention groups
1
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Description
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Negative control group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day and use the gel containing the base of the gel (placebo) three times a day each time for 3 to 5 minutes for 6 Weeks over the involved area.
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Category
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Placebo
2
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Description
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Positive control group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day, and use 1% diclofenac gel three times a day each time for 3 to 5 minutes for 6 weeks over the involved area.
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day and use 3% chicory gel three times a day for 3 to 5 minutes for 6 weeks over the involved area.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Shahrekord University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Information about the main outcome can be shared.
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When the data will become available and for how long
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Start the access period 4 months after publishing the results
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To whom data/document is available
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Researchers working in academia
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Under which criteria data/document could be used
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Use data to complete clinical trial studies
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From where data/document is obtainable
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Kashani Hospital in Shahrekord, dehghan_mortaza@yahoo.com
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What processes are involved for a request to access data/document
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after the investigation of resercher request and presentation of required documents will be accessible.
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Comments
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