Protocol summary

Summary
This study is a randomized clinical trial that aimed to evaluate the dalk(A kind of Iranian massage) effect on type 2 diabetes mellitus. Subjects who are diabetic patients 35- 75 years old men enrolled for study. The patients randomly assigned to intervention and control groups equally 22 in each group. Inclusion criteria are including patients with type2 Diabetes that treating with oral anti-DM drugs; HBA1C more than 6.5% and less than 9%; male patients 35-70 years old; FBS more than 130 and less than 200 mg/dl; not in-taking anticoagulant drugs. Moreover, GFR less than 60 Ml/mi (Glomerular Filtration Rate); increasing of ALT and AST level more than 3 time; Cr more than 2 mg/dl considered as exclusion criteria. The intervention groups will take Dalk massage and beside the current treatment. The control group will take only the routine treatment. The intervention would applied for patients in treatment group for 12 session in 8 weeks. Finally the outcome measures including FBS, HA1C, Insulin, TG, Cholesterol, AST and ALT were compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017022032692N1
Registration date: 2017-06-06, 1396/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Davood Bayat
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 151 1200
Email address
dbayat@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2017-02-26, 1395/12/08
Expected recruitment end date
2017-05-09, 1396/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An evaluation of the Effect of Iranian moderate Dalk ( a kind of Iranian Massage) on Blood Glucose Control in diabetic Type 2 patients.
Public title
The effect of dak;(iranian massage) on type 2 diabetus mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Patients with type2 Diabetes that treating with oral anti-DM drugs; HBA1C more than 6.5% and less than 9%; male patients 35-70 years old; FBS more than 130 and less than 200 mg/dl; Not in-taking anticoagulant drugs exclusion criteria: GFR less than than 60 Ml/mi (Glomerular Filtration Rate); increasing ofALT and AST level more than 3 time; Cr more than 2 mg/dl
Age
From 35 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
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
The ethical committee of Qom University of Medical Sciences
Street address
Plaque 83, 4th Alley, 1/1 Lane, Safashar Street, Qom
City
Qom
Postal code
87366- 37169
Approval date
2017-02-11, 1395/11/23
Ethics committee reference number
IR.MUQ.REC.1395.147

Health conditions studied

1

Description of health condition studied
Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
FBS
Timepoint
At begining and middle and the end of intervention
Method of measurement
According to mg/dl of fasting blood glucose test

2

Description
HBA1C
Timepoint
At begining and middle and the end of intervention
Method of measurement
According to percent of HBA1C that report by laboratorist

Secondary outcomes

1

Description
HBA1C
Timepoint
before and the end of intervention
Method of measurement
blood test

2

Description
Triglyceride
Timepoint
After intervention
Method of measurement
Laboratory Tests

Intervention groups

1

Description
Intervention group has 16 sessions moderate dalk or Iranian massage during 2 months
Category
Treatment - Other

2

Description
Control group only evaluation of laboratory tests will be done
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Zafar Clinic
Full name of responsible person
Dr Parham
Street address
Zafar's bulding, 7thTr Street, Shahrdari Square, Qom
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr Davod Bayat
Street address
No 83 Plaque, 4thh Alley, 1/1 Alley, Safashahr Street, Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom 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
Qom University of Medical Sciences
Full name of responsible person
Dr majid Asghari
Position
PHD Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional Medicine, Qom University of Medical Sciences,
City
Qom
Postal code
Phone
+98 81 3494 6433
Fax
Email
dbayat@muq.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr Davood Bayat
Position
Resident of Traditional Medicine
Other areas of specialty/work
Street address
Saheli Street, Qom
City
Qom
Postal code
Phone
+98 918 151 1200
Fax
Email
dbayat@muq.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Majid Asghari
Position
PHD
Other areas of specialty/work
Street address
Qom
City
Qom
Postal code
Phone
+98 25 3293 7248
Fax
Email
dbayat@muq.ac.ir
Web page address

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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