Protocol summary

Summary
The aim of this study was e investigation the effects of cupping on patients with metabolic syndrome in order to control risk factors and anti-heat shock protein 27. In order to, one hundred and thirty-six patients aged 18-65 years with metabolic syndrome were recruited to participate in this trial. Inclusoin criteria: patients with metabolic syndrome and aged 18 to 65 years old (male and female). Exclusion criteria: patients with systemic disorder, stroke, heart attack, type 1 diabete, secondory dyslipidemia, hemophili and pregnancy. Ten patients were excluded due to exclusion criteria. Patients were randomly assigned into control and experimental groups. Patients in the experimental group were treated with wet cupping combined with dietary advice. Controls were given dietary advice alone. Anthropometric and biochemical parameters were assessed at the baseline, 6 and 12 weeks after treatment. The significance of the data was analyzed using a repeated measure ANOVA.

General information

Acronym
Wet cupping
IRCT registration information
IRCT registration number: IRCT201304098956N4
Registration date: 2013-04-28, 1392/02/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-04-28, 1392/02/08
Registrant information
Name
Shabnam Mohammadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1868 7146
Email address
mohammadish881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Science
Expected recruitment start date
2010-09-03, 1389/06/12
Expected recruitment end date
2011-11-03, 1390/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Wet cupping on Coronary risk factors and anti-hate shock protein of the patients suffering from metabolic syndrome
Public title
Effect of wet cuppingients on patients with metaboilque syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusoin criteria: patients with metabolic syndrome and aged 18 to 65 years old (male and female). Exclusion criteria: patients with systemic disorder, stroke, heart attack, type 1 diabete, secondory dyslipidemia, hemophili and pregnancy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Science
Street address
Mashhad
City
Mashhad
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
87001

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Heat shock protein
Timepoint
6 weeks
Method of measurement
blood test

Secondary outcomes

1

Description
Depression
Timepoint
6 weeks
Method of measurement
Questionaire

Intervention groups

1

Description
Interventional group: wet Cupping+diet
Category
Other

2

Description
Control group: adminstration of diet
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mrs Esmati
Street address
Mashhad- Ghoreshi Departement
City
Mashhad
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shabnam Mohammadi
Position
PhD candidate
Other areas of specialty/work
Street address
Mashhad- Medical Science
City
Mashhad
Postal code
Phone
+98 51 1868 7146
Fax
Email
shabnammhmmd@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Kazem Farahmand
Position
PhD
Other areas of specialty/work
Street address
Mashhad- Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1882 9261
Fax
Email
farahmandk@mums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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