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Investigating the effect of Wet cupping on known cardiovascular risk factors and anti-heat shock protein-27 in patients with metabolic syndrome

Protocol summary

Study aim
Investigating the effect of Wet cupping on Coronary risk factors and anti-hate shock protein in patients with metabolic syndrome
Design
A clinical trial, with the control and intervention groups, single-blinded, was randomized on 136 patients with metabolic syndrome.
Settings and conduct
In wet-cupping, a physician or a trained person create a swelling with a glass and a suction device, in the area between the two scapulae in the opposite side of the thymus gland, then 7 to 14 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, then 3 to 5 consecutive stages, each stage lasting 3 to 5 minutes, are done. Finally, 50 to 70 cc of the participant’s blood was taken. Then, the cupping area was completely covered with gas and glue.
Participants/Inclusion and exclusion criteria
Males and females aged between 18 and 65 with metabolic syndrome were allowed to participate in the study; also, participants had not any infectious diseases or coagulopathies, and did not consume any therapeutic diet and/or medication. Individuals with a history of stroke and ischemic heart disease, or consume a therapeutic diet and medication were not allowed to participate in the study.
Intervention groups
The control group was recommended to follow a special diet for a month. Next, 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. The intervention group was prescribed with the diet and wet-cupping by a specialist. After a month a blood sample (20 cc) was taken from them and the diet and second wet-cupping were prescribed to them again. After another month the last blood sample was taken from them.
Main outcome variables
prevention of hypertension; reduction in anti-hsp27 level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201101049213N1
Registration date: 2020-11-18, 1399/08/28
Registration timing: retrospective

Last update: 2020-11-18, 1399/08/28
Update count: 0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Ali Ebrahimi Dabagh
Name of organization / entity
Varastegan Institute for Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3890 2249
Email address
ebrahimial@varastegan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-31, 1396/05/09
Expected recruitment end date
2017-12-17, 1396/09/26
Actual recruitment start date
2017-07-31, 1396/05/09
Actual recruitment end date
2017-12-17, 1396/09/26
Trial completion date
2018-02-16, 1396/11/27
Scientific title
Investigating the effect of Wet cupping on known cardiovascular risk factors and anti-heat shock protein-27 in patients with metabolic syndrome
Public title
The effect of Wet cupping on metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 136
Actual sample size reached: 136
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
All participants were not informed about the existence in the control or intervention groups.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Human Research Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
IRMUMSREC.1395.468

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

Primary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

5

Description
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

6

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Devices

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Laboratory of Imam Reza Hospital
Full name of responsible person
Maryam Mohammadi
Street address
Imam Reza Square, Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
Email
IRH.p.relations@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Maryam Mohammadi
Street address
Ghaem Hospital, Ahmad Abad Street, Dr. Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3840 0001
Fax
Email
Quaem.Medical.Center@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Azadi Square, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3711 2389
Email
ghayourm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
A clerk at Mashhad University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Biology
Street address
Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
mohammadim3@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kazem Farahmand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Azadi Square, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
FarahmandK1@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Varastegan Institute For Medical Sciences
Full name of responsible person
Ali Ebrahimi Dabagh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nutrition
Street address
Varastegan Institute For Medical Sciences, on the corner of Ladan 3, Ladan Street, Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9179666769
Phone
+98 51 3509 1160
Email
ebrahimial@varastegan.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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