Protocol summary

Summary
Objective: the effect of 8 weeks of aerobic training and the consumption of alcoholic extract of nettle on apelin and plasma CRP levels in overweight and obese women study design: Randomized sealed envelope; single-blind (Participants); placebo-controlled; single-cente. Inclusion criteria: female gender; age; no history of heart disease; arthritis; do not use other herbal medicines. Exclusion criteria: use of herbal medicines except nettle; pregnancy; breastfeeding; risk of other seroud diseases. Sample size of 48 patients in 4 groups. Outcomes: cardiovascular risk factors associated with obesity and weight loss with exercise and use of nettle extract.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015100824424N1
Registration date: 2016-05-03, 1395/02/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-03, 1395/02/14
Registrant information
Name
Mitra Madadi Jaberi
Name of organization / entity
Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 71 3831 4780
Email address
mitra.madadi@pgs.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2015-12-06, 1394/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of aerobic training and the consumption of alcoholic extract of nettle on apelin and pelasma CRP levels in overweight and obese women
Public title
The Effect Of Exercise And Extract Nettle On Obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female gender; age; lack of any history of cardiovascular disease, arthritis and ...; do not use other herbal medicines. Exclusion criteria: use of herbal medicines except nettle; pregnancy; breastfeeding; risk of diseases.
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences of zahedan
Street address
Zahedan Persian Gulf Boulevard, healthcare Zahedan University of Medical Sciences
City
Zahedan
Postal code
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
ir.zaums.rec.1394.418

Health conditions studied

1

Description of health condition studied
Obesity and overweight
ICD-10 code
E66.0, E66
ICD-10 code description
Obesity due to excess calories; Morbid obesity; Simple obesity NOS

Primary outcomes

1

Description
Apelin
Timepoint
Before the intervention. Immediately after the intervention
Method of measurement
Kate Apelin

2

Description
CRP
Timepoint
Before the intervention. Immediately after the intervention
Method of measurement
Kate CRP

Secondary outcomes

1

Description
Blood pressure
Timepoint
The beginning of training, immediately after training
Method of measurement
Manometers

2

Description
Heart rate
Timepoint
The beginning of training, immediately after training
Method of measurement
thermometers Polar heart rate

3

Description
Weight
Timepoint
14 hours before the start of practice and 24 hours after 8 weeks
Method of measurement
Balance

4

Description
BMI
Timepoint
The beginning of training, immediately after training
Method of measurement
Weight / height to the power of 2.

Intervention groups

1

Description
Intervention group 1 : Aerobic + Extract
Category
Treatment - Drugs

2

Description
Control group 1 : Aerobic + placebo supplement.
Category
Treatment - Drugs

3

Description
Placebo that is a combination of medication and water-color 100 mg three times a day is used. Resistance training 30 to 40 minutes
Category
Treatment - Drugs

4

Description
Control group: placebo supplement.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Olympic Village city of Zahedan
Full name of responsible person
Street address
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Dr. Mohammad Kordi Tamandani, Research Department
Street address
Zahedan, Sistan and Baluchestan University
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Sistan and Baluchestan
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
Zahedan University of Medical Sciences
Full name of responsible person
Mansour Karajibani
Position
PhD
Other areas of specialty/work
Street address
zahedan zahedan university of medical sciences
City
Zahedan
Postal code
Phone
+98 54 3329 5796
Fax
Email
mitra.madadi@pgs.usb.ac.ir mitra.madadi93@gmail.com mkarajibani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mansour Karajibani
Position
PhD
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Dr. Hesabi square
City
Zahedan
Postal code
Phone
+98 54 3329 5796
Fax
Email
mkarajibani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mansour Karaji Bani
Position
PhD
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Dr. Hesabi square
City
Zahedan
Postal code
Phone
Fax
Email
mitra.madadi93@gmail.com; mitra.madadi@pgs.usb.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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