Protocol summary
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Study aim
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Effect of herbal ointment on pain relief and osteoarthritis
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Design
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80 patients with severe and moderate knee pain will be divided randomly (with a randomized table),into two groups of 40, one group: ointment and the other group will receive methyl salicylate in three times a day for four weeks . Phase III clinical trial.
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Settings and conduct
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Patients are referred to researcher by two orthopedic or rheumatologic specialists from two treatment centers affiliated to Imam Reza and Ghaem Hospital in Mashhad. Researcher and responsible for collecting and analyzing data and writing articles are blind.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
primary osteoarthritis in knee
Pain: Score over 40 (Visual Scale)
age:60 - 80 years
exclusion criteria:
Patient dissatisfaction
Need for supplementary treatment
Skin disease or ulceration at the place of Drug use
Patients treated with hormonal drugs
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Intervention groups
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Intervention group: Herbal ointment: ginger, pepper and peppermint in knee osteoarthritis
Control group: Methyl salicylate ointment in knee osteoarthritis
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Main outcome variables
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Reduce knee pain
Increase knee performance
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:
IRCT20171112037401N3
Registration date:
2018-02-01, 1396/11/12
Registration timing:
registered_while_recruiting
Last update:
2019-02-18, 1397/11/29
Update count:
1
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Registration date
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2018-02-01, 1396/11/12
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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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Deputy of Research and Technology, Mashhad University of Medical Sciences
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Expected recruitment start date
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2017-12-21, 1396/09/30
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Expected recruitment end date
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2018-07-21, 1397/04/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the Effect of "Herbal ointment (Ginger, Black Pepper and Rose)" with "Methyl Salicylate ointment" on Improving pain and functional disorders in patients with knee arthritis
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Public title
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Comparison of the Effect of "Herbal Ointment " with" Methyl Salicylate Ointment " in patients with knee arthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Symptomatic primary osteoarthritis in knee approved
by clinical or radiological criteria
Pain: Score over 40 (Visual Scale)
Age: 60 - 80 years
Exclusion criteria:
Patient dissatisfaction
Drug use
Patients treated with hormonal drugs
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Age
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From 60 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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- Participant
- Investigator
- Outcome assessor
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
80
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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
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The participant - investigator - the outcome evaluation - the outcome of the safety committee and the data monitoring committee do not know what kind of ointment.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Herbal medicine design with Iranian medicine approach
Ethics committees
1
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Ethics committee
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Approval date
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2017-07-15, 1396/04/24
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Ethics committee reference number
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IR.MUMS.REC.1396.141
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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m17.9
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ICD-10 code description
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Gonarthrosis
Primary outcomes
1
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Description
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Joint stiffness
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Timepoint
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Two weeks after start the treatment, then every two weeks for two months
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Method of measurement
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WOMAC questionnaire
2
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Description
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pain
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Timepoint
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Two weeks after start the treatment, then every two weeks for two months
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Method of measurement
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The VAS criterion
3
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Description
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Physical action
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Timepoint
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Two weeks after start the treatment, then every two weeks for two months
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Method of measurement
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WOMAC questionnaire
Secondary outcomes
1
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Description
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Dissatisfaction
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Timepoint
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Two weeks after start the treatment, then every two weeks for two months
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Method of measurement
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Discontinue the treatment
Intervention groups
1
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Description
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Intervention group 1: prescribing herbal ointment containing the juice of three plants: pepper, cinnamon, and roses with equal ratio in a base of animal oil lubricant base, will give to three doses daily for two months. Ointment is made at the Mashhad Faculty of Traditional Medicine.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Methyl salicylate ointment 30 g (each 100 g contain 15 g of methyl salicylate and 10 g of menthol) made by Sobhan-Dar company is given in three daily doses for two months.
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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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Mashhad University of Medical Sciences ,Vice chancellor for research
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available