Protocol summary

Summary
Given the increasing prevalence of diabetes in the country, and recommendations of the World Health Organization Expert Committee about more investigation Herbal medicines as a method for treating diabetes and tender of most people to use herbal remedies instead of drugs; this study investigate the effect of nettle extract on glycemic index, lipid profile and insulin resistant in patients with type2 diabetes. A randomized double-blinded clinical trial was done on 60 patients with type2 diabetes in clinical diabetes for 8 weeks. Inclusion criteria: both genders over the age of 30 years old and common diabetes drugs usage (metformin, glibenclamid); patients not suffering from renal disorder and cardiovascular; do not use of NSAIDS(non steroid anti inflammatory drugs); not using estrogen and progesterone drugs. Patients were advised to continue their diet and physical activity habits without any changes during intervention and received 100mg/kg nettle extract and placebo 3 times a day after each 3 main meals. For admission of patients they dissolved one saccharin tablet in glasses of extract. Placebo well as water and green food preparation is allowed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013062013727N1
Registration date: 2013-07-23, 1392/05/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-23, 1392/05/01
Registrant information
Name
Roya Khajeh Mehrizi
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 2522 7900
Email address
mozaffari.kh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2013-07-11, 1392/04/20
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nettle extract on glycemic index,lipid profile and insulin resistant in patients with type2 diabetes
Public title
The effect of nettle extract in diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: both genders over the age of 30 years old and common diabetes drugs usage(metformin, glibenclamid). Exclusion criteria: patients with renal disorder; cardiovascular, liver, infections, thyroid diseases, allergies; use of NSAIDS (non steroid anti inflammatory drugs); use of estrogen and progestron drugs; pregnancy and breastfeeding and participate in other trials.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
Building No. 2- Shahid Sadoughi Boulevard- Bahonar square
City
Yazd
Postal code
Approval date
2013-03-17, 1391/12/27
Ethics committee reference number
188706

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E10-11
ICD-10 code description
Insulin-dependent diabetes mellitus, Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Blood glucose level
Timepoint
Before study and 8 weeks after intervention
Method of measurement
Fasting blood glucose concentrations

Secondary outcomes

1

Description
LDL-cholesterol
Timepoint
Early Intervention and 8 weeks after intervention
Method of measurement
LDL-cholesterol concentratiom

2

Description
HDL-cholesterol
Timepoint
Early Intervention and 8 weeks after intervention
Method of measurement
HDL-cholesterol concentration

3

Description
Triglyceride
Timepoint
Early Intervention and 8 weeks after intervention
Method of measurement
Triglyceride concentration

4

Description
Cholesterol
Timepoint
Early Intervention and 8 weeks after intervention
Method of measurement
Cholesterol concentration

5

Description
Blood insulin
Timepoint
Early Intervention and 8 weeks after intervention
Method of measurement
Insulin concentration

Intervention groups

1

Description
Extract nettle for 8 weeks, received 100mg/kg 3 main meal
Category
Treatment - Drugs

2

Description
Water and green food preparation for 8 weeks after 3 main meal
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Azadshahr Health Center
Full name of responsible person
Roya Khajeh Mehrizi
Street address
Shahrak Shahid Rajayi, Mehriz
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research
Full name of responsible person
Dr. Hassan Mozaffari
Street address
Building No. 2, Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research
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
Yazd University of Medical Sciences
Full name of responsible person
Roya Khajeh Mehrizi
Position
Researcher
Other areas of specialty/work
Street address
Shahrak Shahid Rajayi, Mehriz
City
Yazd
Postal code
Phone
+98 35 2522 5567
Fax
Email
khajehroya@gmail.com; royakhajehmehrizi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Hassan Mozaffari
Position
Professor
Other areas of specialty/work
Street address
Daneshjou boulvared
City
Yazd
Postal code
Phone
+98 35 1724 0171
Fax
Email
mozaffari.kh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Roya Khajeh Mehrizi
Position
Researcher
Other areas of specialty/work
Street address
Shahrak Shahid Rajayi, Mehriz
City
Yazd
Postal code
Phone
+98 35 2522 5567
Fax
Email
royakhajehmehrizi@yahoo.com; khajehroya@gmail.com
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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