Protocol summary
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Study aim
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Determining the effect of black seed oil massage on the severity of restless legs syndrome in patients with type 2 diabetes
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Design
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Clinical trial with control group, with parallel groups, one-way blind, randomized, phase 3-2 on 76 patients. For randomization, Sealed Envelope Ltd. software 2017 was used.
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Settings and conduct
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The samples studied in this study include all patients with moderate to severe foot syndrome who are hospitalized in Shahid Beheshti Hospital of Kashan University of Medical Sciences. The method of massage is such that each person after soaking the palms with black oil The bead (2 cc) with continuous pressure of the fingers starts the massage from the toes and then the sole of the foot and gradually continues to the top of the knee. In the control group, only routine and routine actions will be performed.
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Participants/Inclusion and exclusion criteria
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Having type 2 diabetes, No diabetic foot ulcers, Lack of allergy to black seed oil, no use of sleeping pills and psychiatric drugs, No heart, lung or brain disease
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Intervention groups
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Intervention group: In addition to the usual and routine treatments such as pramipexole and cabergoline, gabapentin, benzodiazepines, ibuprofen and codeine, massage the feet with black seed oil overnight for 40 nights. Control group: Only conventional and routine treatments such as pramipexole and receive cabergoline, gabapentin, benzodiazepines, ibuprofen and codeine.
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Main outcome variables
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Severity of restless leg syndrome
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:
IRCT20100211003329N8
Registration date:
2022-02-24, 1400/12/05
Registration timing:
prospective
Last update:
2022-03-11, 1400/12/20
Update count:
1
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Registration date
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2022-02-24, 1400/12/05
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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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Expected recruitment start date
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2022-03-06, 1400/12/15
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Expected recruitment end date
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2022-04-19, 1401/01/30
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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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The effect of black seed oil massage on the severity of restless legs syndrome in patients with type 2 diabetes
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Public title
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The effect of black seed oil massage on the severity of restless legs syndrome in patients with type 2 diabetes
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness to participate in research and conscious satisfaction
Having type 2 diabetes
Lack of sensitivity to black seed oil
Do not take sleeping pills and psychiatric drugs
Exclusion criteria:
diabetic foot ulcers
heart, lung or brain disease
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Age
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No age limit
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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How to select the samples will be randomly assigned to each of the two intervention and comparison groups in block, 4, 6 and 8 blocks. Using Sealed Envelope Ltd. software. 2017 Through the site www.sealedenvelope.com 3 blocks of 4, 6 blocks of 6 and 4 blocks of 8, a total of 13 blocks (In the form of a number) were defined, which will be assigned to groups according to the order specified by the tool.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Outcome assessors and analyzer are unaware of the effect of black seed oil massage on Restless Legs Syndrome in type 2 diabetic patients.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2022-02-07, 1400/11/18
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Ethics committee reference number
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IR.KAUMS.NUHEPM.REC.1400.064
Health conditions studied
1
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Description of health condition studied
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Restless legs Syndrom
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ICD-10 code
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G25.81
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ICD-10 code description
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Restless legs syndrome
2
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Description of health condition studied
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Diabetes Type 2
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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Severity of restlessness leg syndrome
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Timepoint
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Before the intervention, after the intervention
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Method of measurement
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Using the standard Restless Legs Syndrome checklist
Intervention groups
1
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Description
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Intervention group: The subject and objectives of the study are explained for each of participants, and if she/he wish to participate in the study, a questionnaire for diagnosing Restless Legs Syndrome and a checklist of demographic information for patients will be completed. It should be noted that skin sensitivity of individuals to study is also examined. For this purpose, 5 cc of black seed oil is massaged on the person's skin with the desired purity, and in case of any symptoms of erythema, inflammation, blisters and other symptoms of skin allergies, while eliminating the person's symptoms, it will be removed from the study. Eligible individuals (earning a score of 11 or higher according to the IRLSS checklist) after being selected and obtaining consent to participate in the study, are introduced, reviewed, and randomly entered to study.In the intervention group for 40 nights, one night in between, before going to bed, black seed oil prepared from Barij Essential Oil Company with a purity of 5%, in the amount of 2 cc is used for each foot (a total of 80 cc for each participant should be considered). Will give, and for heterosexual participants, the male colleague will be helped to train the male participants and do it once.The method of massage is such that each person Applying black palm oil (2 cc) on the palms of the hands, continuously massaging the fingers from the toes, then the soles of the feet and gradually continuing to the top of the knees. At the end of the intervention, restlessness questionnaires were completed for patients in both groups.
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Category
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Treatment - Drugs
2
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Description
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Control group: In the control group, only routine treatments (Take drugs such as pramipexole and cabergoline, gabapentin, benzodiazepines, ibuprofen and codeine) will be performed
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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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Kashan 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Not done yet
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Study Protocol
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No - There is not 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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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not 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