]>
IRCT20230528058314N1 IRCT 2023-07-11 Ghoum University of Medical Sciences "foot bath in control of Diabetes" Evaluation of the effect of warm salt water foot bath on control of blood glucose in type2 Diabetic patients with cold temperament 2023-07-23 anticipated 52 Complete https://irct.ir/trial/70496 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A control of blood glucose in type2 Diabetic patients. Intervention 1: 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. Intervention 2: Control group: There is no intervention (warm water and salt are not prescribed). Yes - There is a plan to make this available What will be shared: Data will be sent by researchers upon request. When: All potential data can be shared after de-identifying individuals. To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: 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. Where to obtain: To receive the desired documents and data, please refer to the Faculty of Traditional Medicine of Qom University of Medical Sciences. How to obtain: 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. Comments:
public Zahra sadat Salehi
Panzdah khordad
Qom Iran (Islamic Republic of) 3714848350 +98 25 3776 4073 zsalehi@muq.ac.ir Ghoum University of Medical Sciences scientific Majid Asghari
Panzdah khordad
Qom Iran (Islamic Republic of) 3714848350 +98 25 3776 4073 asghari.rall@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) 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 20 years 60 years Both 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 E11 Type 2 diabetes mellitus Treatment - Devices N/A 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. Control group: There is no intervention (warm water and salt are not prescribed) HGA1C. Timepoint: The beginning of the study and 3 months later. Method of measurement: plasma Glycosylated hemoglobin /lab kit. FBS. Timepoint: The beginning of the study and 3 months later. Method of measurement: lab kit. Serum Insolin. Timepoint: The beginning of the study and 3 months later. Method of measurement: lab kit. Ghoum University of Medical Sciences Approved 2023-05-08 Working Group/Committee of Ethics in Research, Qom University of Medical Sciences No. 83, Shahid Lotfi Niaser, Shahid Lotfi Niaser, Safashehr St., No. 83 Qom Markazi Iran (Islamic Republic of)