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IRCT20201101049213N1 IRCT 2020-11-18 Mashhad University of Medical Sciences The effect of Wet cupping on metabolic syndrome Investigating the effect of Wet cupping on known cardiovascular risk factors and anti-heat shock protein-27 in patients with metabolic syndrome 2017-07-31 anticipated 136 Complete https://irct.ir/trial/51988 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: In this randomized clinical trial study, after excluding criteria 136 patients will be recruited. Individuals will be randomized by PASS application and dual block randomization method. One hundred and thirty-six number will be divided into two groups ( A: Intervention group, B: Control group), the codes and names are written on a paper and are put in a paper packet. The first participant picks up packet number 1 and is guided to the respective group. Then the second participant picks up packet number 2 and the process continues until all participants are allocated. Due to the type of treatment, there is no possibility of allocation concealment, and blindness could be only single-blind, Blinding description: All participants were not informed about the existence in the control or intervention groups. N/A Metabolic Syndrome. Intervention 1: Intervention group: The diet and wet-cupping treatment were prescribed to the intervention group by a specialist. After a month, blood samples (20 cc) of the participants were taken and the diet and second wet-cupping treatment were prescribed to individuals again. After another month the last blood samples were taken from participants. Wet-cupping was performed by a physician or a trained person as general type. A swelling with a glass and a suction device was created, in the area between the two scapulae in the opposite side of the thymus gland, and thereafter, some superficial scratches were created on the skin parallel to the midline of the body with a distance of 3 to 5 mm between scratches. The length of each scratch was between 5 to 10 mm. 7 to 14 scratches were created, as they covered the entire cupping area. Finally, cupping was done in 3 to 5 consecutive stages; each stage lasted 3 to 5 minutes. At the end of cupping, 50 to 70 cc of the participant’s blood was taken, through dilatation and aspiration of capillaries. Then, the cupping area was completely covered with gas and glue. Intervention 2: Control group: The control group was recommended to follow a special diet for one month. Next (after 1 month), the second blood sample was taken from them. Then they followed the diet for another month. Finally, the third blood sample was taken from them. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Maryam Mohammadi
Mashhad University of Medical Sciences, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 mohammadim3@mums.ac.ir Mashhad University of Medical Sciences scientific Kazem Farahmand
Azadi Square, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 FarahmandK1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having metabolic syndrome Age range: 18 to 65 years old Male or female Resident in Mashhad city Absence of consumption of any therapeutic diet and/or medication (antilipidemic medications) Absence of infectious diseases or coagulopathies 18 years 65 years Both Ages under 18 and above 65 years old Individuals with the history of stroke and ischemic heart disease Consuming a specific therapeutic diet and/or medication Diabetes mellitus type 1 Presence of any infectious disease based on the patient statement, but not be documented by laboratory tests E88.81 Metabolic syndrome Treatment - Devices Treatment - Other Intervention group: The diet and wet-cupping treatment were prescribed to the intervention group by a specialist. After a month, blood samples (20 cc) of the participants were taken and the diet and second wet-cupping treatment were prescribed to individuals again. After another month the last blood samples were taken from participants. Wet-cupping was performed by a physician or a trained person as general type. A swelling with a glass and a suction device was created, in the area between the two scapulae in the opposite side of the thymus gland, and thereafter, some superficial scratches were created on the skin parallel to the midline of the body with a distance of 3 to 5 mm between scratches. The length of each scratch was between 5 to 10 mm. 7 to 14 scratches were created, as they covered the entire cupping area. Finally, cupping was done in 3 to 5 consecutive stages; each stage lasted 3 to 5 minutes. At the end of cupping, 50 to 70 cc of the participant’s blood was taken, through dilatation and aspiration of capillaries. Then, the cupping area was completely covered with gas and glue. Control group: The control group was recommended to follow a special diet for one month. Next (after 1 month), the second blood sample was taken from them. Then they followed the diet for another month. Finally, the third blood sample was taken from them. Fasting Blood Glucose (FBG). Timepoint: Measurement of the FBG at the beginning of the study and a month, 2 months after finishing Wash Out Diet. Method of measurement: Blood sample. HDL. Timepoint: Measurement of the HDL at the beginning of the study and a month, 2 months after finishing Wash Out Diet. Method of measurement: Blood sample. LDL. Timepoint: Measurement of the LDL at the beginning of the study and a month, 2 months after finishing Wash Out Diet. Method of measurement: Blood sample. Cholesterol. Timepoint: Measurement of the blood cholesterol at the beginning of the study and a month, 2 months after finishing Wash Out Diet. Method of measurement: Blood sample. Triglyceride. Timepoint: Measurement of the blood triglyceride at the beginning of the study and a month, 2 months after finishing Wash Out Diet. Method of measurement: Blood sample. Anti-hsp27. Timepoint: Measurement of the anti-hsp27 at the beginning of the study and a month, 2 months after finishing Wash Out Diet. Method of measurement: Blood sample. Mashhad University of Medical Sciences Approved 2016-12-24 Human Research Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Azadi square Mashhad Razavi Khorasan Iran (Islamic Republic of)