Determining the effect of black seed oil massage on the severity of restless legs syndrome in patients with type 2 diabetes
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Severity of restless leg syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100211003329N8
Registration date:2022-02-24, 1400/12/05
Registration timing:prospective
Last update:2022-02-24, 1400/12/05
Update count:1
Registration date
2022-02-24, 1400/12/05
Registrant information
Name
Zahra Sooki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
sooki_za@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of black seed oil massage on the severity of restless legs syndrome in patients with type 2 diabetes
Public title
The effect of black seed oil massage on the severity of restless legs syndrome in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessors and analyzer are unaware of the effect of black seed oil massage on Restless Legs Syndrome in type 2 diabetic patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan. Qutb Ravandi Blvd., Pezeshk Blvd., Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
87155981151
Approval date
2022-02-07, 1400/11/18
Ethics committee reference number
IR.KAUMS.REC.1400.064
Health conditions studied
1
Description of health condition studied
Restless legs Syndrom
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
2
Description of health condition studied
Diabetes Type 2
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Severity of restlessness leg syndrome
Timepoint
Before the intervention, after the intervention
Method of measurement
Using the standard Restless Legs Syndrome checklist
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: In the control group, only routine treatments (Take drugs such as pramipexole and cabergoline, gabapentin, benzodiazepines, ibuprofen and codeine) will be performed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti hospital
Full name of responsible person
Zohre khalaj
Street address
Ghotb Ravandi
City
Kashan
Province
Isfehan
Postal code
87159 88111
Phone
+98 31 5554 0026
Fax
+98 31 5554 6633
Email
z.sooki@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Hamidreza Banafsheh
Street address
Ghotb Ravandi
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9021
Fax
+98 31 5554 6633
Email
banafsheh_h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mansour Dianati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9021
Fax
+98 31 5554 6633
Email
mandianati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mansour Dianati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9021
Fax
+98 31 5554 6633
Email
mandianati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Sooki
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9021
Fax
+98 31 5554 6633
Email
z.sooki@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD