The effect of aerobic exercise ergometer with the consumption extract of Nettle on the Nesfatin-1 and C-reactive protein values in overweight and obese women.
Objective: The effect of aerobic exercise ergometer with the consumption extract of Nettle on the Nesfatin-1 and C-reactive protein values in overweight and obese women. Study design: Randomized sealed envelope؛ single-blind (Participants) ؛ placebo-controlled؛ single-cente. Inclusion criteria: Female؛ Age between 25 to 45 years؛ no history of heart disease؛ arthritis؛ being healthy؛ do not use other herbal medicines، lack of regular exercise. Exclusion criteria: use of herbal medicines except nettle؛ Pregnancy؛ Breastfeeding؛ Risk of disease and ..... sample size of 48 patients in 4 groups. Time: 11 January 2016 till 5 March 2016. Outcome: 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:IRCT2016022324394N2
Registration date:2016-03-20, 1395/01/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-20, 1395/01/01
Registrant information
Name
Soheila Moghadam Eftekhari
Name of organization / entity
University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 51 5452 1979
Email address
fiziolozhi.usb93@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 aerobic exercise ergometer with the consumption extract of Nettle on the Nesfatin-1 and C-reactive protein values in overweight and obese women.
Public title
The effect of exercise and extract Nettle on obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female؛ Age between 25 to 45 years؛ lack of any history of cardiovascular disease, arthritis and ...؛ to health؛ do not use other herbal medicines، lack of regular exercise.
Exclusion criteria: use of herbal medicines except nettle؛ Pregnancy؛ Breastfeeding؛ Risk of disease and ....
Age
From 69 years old to 49 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
Carry out a sealed envelope method is to randomly.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences of zahedan
Street address
98167-43463
City
zahedan
Postal code
Approval date
2016-01-31, 1394/11/11
Ethics committee reference number
IR.ZAUMS.REC.1394..388
Health conditions studied
1
Description of health condition studied
Obesity and overweight
ICD-10 code
E66.0، E6
ICD-10 code description
Obesity due to excess calories، Morbid obesity، Simple obesity NOS.
Primary outcomes
1
Description
Nesfatin-1
Timepoint
Before the intervention. Immediately after the intervention
Method of measurement
Kate Nesfatin-1
2
Description
CRP
Timepoint
Before the intervention. Immediately after the intervention
Method of measurement
Kate CRP
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before the intervention. Immediately after the intervention
Method of measurement
Manometers
2
Description
Heart rate
Timepoint
Before the intervention. Immediately after the intervention
Method of measurement
thermometers Polar heart rate
3
Description
waist to hip ratio
Timepoint
Before the intervention. Immediately after the intervention
Method of measurement
Waist circumference / Hip circumference
4
Description
BMI
Timepoint
Before the intervention. Immediately after the intervention
Method of measurement
Weight / height to the power of 2.
Intervention groups
1
Description
Intervention group 1 : Aerobic + Extract.
Participants must daily for 2 months, 8 ml of nettle extract has been solved, while in a glass of water after meals to consume. It should be noted that extract essential oils from medicinal plants Gorgan is provided.
Category
Treatment - Drugs
2
Description
Intervention group 2: Extract.
Participants must daily for 2 months, 8 ml of nettle extract has been solved, while in a glass of water after meals to consume. It should be noted that extract essential oils from medicinal plants Gorgan is provided.
Category
Treatment - Drugs
3
Description
Control group 1 : Aerobic + placebo supplement.
Category
Treatment - Drugs
4
Description
Control group 2 : placebo supplement.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Olympic Village of Zahedan city
Full name of responsible person
Soheila Moghadam Eftekhari
Street address
Bozorgmehr Ave، Zahedan
City
zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Soheila Moghadam Eftekhari
Street address
95916-34576
City
Taybad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
98167-43463
City
Zahedan
Postal code
Phone
+98 915 341 4358
Fax
Email
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
95167-43463
City
Zahedan
Postal code
Phone
+98 915 341 4358
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
Mansur Karajibani
Position
PHD
Other areas of specialty/work
Street address
95167-43463
City
Zahedan
Postal code
Phone
+98 915 341 4358
Fax
Email
mkarajibani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)