Determining the effect of warm salt water bath on blood Glucose control in type 2 diabetic patients with cold temperament
Design
Clinical trial with control group, parallel groups, randomized by epidemiologist (randomized balanced block method), on 52 patients.
Settings and conduct
Diabetic patients referring to Salamatkade Iranian Medicine in Qom and Endocrine Clinic of Qom Kamkar Hospital who have the study inclusion criteria are selected by the researcher, then the details of the study will be explained by the researcher, then a questionnaire of demographic characteristics and disease information will be prepared and Patients are randomly assigned to one of two treatment groups.
Participants/Inclusion and exclusion criteria
inclusion Criteria:
1. Diabetic patients with a cold temperament and aged 20 to 60 years
2. FBS>130 or HGA1C between 7 and 10
3. Not starting to take antidiabetic drugs (herbal and non-herbal) from one month before entering the study
4. Consent to not using treatments outside the protocol
Non inclusion Criteria:
1. Unstable kidney, heart and brain complications and history of other diseases (types of malignancies, rheumatological diseases, thyroid diseases and other hormonal diseases, other special diseases)
2. Patients who have received systemic corticosteroids in the last month ulcerous lesions on the foot Pregnancy and breastfeeding
3. Using alternative medical therapy such as massage, cupping, etc. during the month before the study
4. Patients who have a history of blood pressure less than 100 mmHg or who have had orthostatic hypotension
5. proteinuria, hematuria
6. hypermenorrhea
7. DVT, severe foot edema
Intervention groups
Intervention group: using warm salt water foot bath(Abzan)
Control group: Without using foot bath
Main outcome variables
blood glucose control(FBS,HGA1C,Serum Insolin)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230528058314N1
Registration date:2023-07-11, 1402/04/20
Registration timing:prospective
Last update:2023-07-11, 1402/04/20
Update count:0
Registration date
2023-07-11, 1402/04/20
Registrant information
Name
zahra sadat salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3776 4073
Email address
zsalehi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of warm salt water foot bath on control of blood glucose in type2 Diabetic patients with cold temperament
Public title
"foot bath in control of Diabetes"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients with a cold temperament and aged 20 to 60 years
FBS>130 or HGA1C between 7 and 10
Not starting to take antidiabetic drugs (herbal and non-herbal) from one month before entering the study
Consent to not using treatments outside the protocol
Exclusion criteria:
Unstable kidney, heart and brain complications and history of other diseases (types of malignancies, rheumatological diseases, thyroid diseases and other hormonal diseases, other special diseases)
Patients who have received systemic corticosteroids in the last month
ulcerous lesions on the foot
Pregnancy and breastfeeding
Using alternative medical therapy such as massage, cupping, etc. during the month before the study
Patients who have a history of blood pressure less than 100 mmHg or who have had orthostatic hypotension
proteinuria, hematuria
hypermenorrhea
DVT, severe foot edema
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com). Allocation concealment is also guaranteed due to the use of special codes generated by the website.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working Group/Committee of Ethics in Research, Qom University of Medical Sciences
control of blood glucose in type2 Diabetic patients
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
HGA1C
Timepoint
The beginning of the study and 3 months later
Method of measurement
plasma Glycosylated hemoglobin /lab kit
2
Description
FBS
Timepoint
The beginning of the study and 3 months later
Method of measurement
lab kit
3
Description
Serum Insolin
Timepoint
The beginning of the study and 3 months later
Method of measurement
lab kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for 3 months, every other night, (before going to bed), sitting on a chair with a support and legs in an angled position and extended up to the top of the wrist in the same special container, containing 5 liters of tolerable and pleasant warm water (between 41 to 37 degrees Celsius) to which 250 grams of salt is added and dissolved in it; They put for 30 minutes. During the work, the temperature of the water in the container must remain the same (for this purpose, the water heater of Tan Aram Hirad, a member of the Qom Medical Sciences Development Center is used) and the surrounding air must be balanced so that the participant does not feel cold. Only about 5 cm above the wrist will be uncovered so that the patient's body does not get cold. It is also explained to the participants to use city tap water to prepare hot water. At the end of the work, after drying the feet with a towel, wear socks and rest.The salt used in this study was prepared and refined from the Jahrom salt mine and has a special brand of Mosallas Salamat Company. The amount of salt required for each session has been prepared by the presenter in 250 gram packages to ensure the same plan between the participants.
Category
Treatment - Devices
2
Description
Control group: There is no intervention (warm water and salt are not prescribed)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamkar hospital
Full name of responsible person
zahra sadat salehi
Street address
19th Street, Charrah Bazar, Qom
City
Qom
Province
Markazi
Postal code
3713814975
Phone
+98 25 3771 3511
Email
kamkar@muq.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Rahim Aali
Street address
No.83 ,Lotfi Niasar., Jahad Daneshgahi , Safa Shahr St.
City
Qom
Province
Markazi
Postal code
3716993456
Phone
+98 25 3285 2720
Email
research@mail.muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Zahra sadat Salehi
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Panzdah khordad
City
Qom
Province
Ghoum
Postal code
3714848350
Phone
+98 25 3776 4073
Fax
Email
zsalehi@muq.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Majid Asghari
Position
Doctor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Panzdah khordad
City
Qom
Province
Ghoum
Postal code
3714848350
Phone
+98 25 3776 4073
Fax
Email
asghari.rall@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zahra sadat Salehi
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Panzdah khordad
City
Qom
Province
Ghoum
Postal code
3714848350
Phone
+98 25 3776 4073
Fax
Email
zsalehi@muq.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data will be sent by researchers upon request.
When the data will become available and for how long
All potential data can be shared after de-identifying individuals.
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data will be used only for use in published research articles and will not be made available to the public in any other way.
From where data/document is obtainable
To receive the desired documents and data, please refer to the Faculty of Traditional Medicine of Qom University of Medical Sciences.
What processes are involved for a request to access data/document
The data will be accessible from the time of announcing the request to the responsible person and proving the scientific documents of the applicant that they are working researchers at the university, as well as reviewing the relevant study and research.