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The studdy effect of aquitic extract of Urtica dioica L. on Glycemic and and Lipidmic indexes in diabetic Patients

Protocol summary

Summary
The purpose of the study: The Effect of Urtica dioica L. On Glucose and Lipid Indexes in Diabetic Patients Design study:Randomized, not blind, placebo-controlled, single-center, phase 3 trial The study population: 180 patients with type 2 diabetes The main inclusion criteria: age over 30 years; HbA1c less than 10 %; the most common diabetes medications ( Metformin ،Glibenclamide ) The main exclusion criteria: a history of cardiovascular disease; renal disease; infectious disease; liver disease; thyroid disease; allergies disease; angina disease; consumption of nonsteroidal antiinflammatory drugs (NSAIDs); consumption of warfarin; consumption of estrogen and progesterone drugs; smoking, consumption of dietary supplements; consumption of herbal decoction; pregnancy and lactation Sample size:180 patients The intervention used in the study: aqueous extract of nettle as medicine and Lemon water as placebo intervention time: At a rate of 1 ml daily for three months, Half an hour before a meal, During the month the 100 cc are used. Primary outcomes: HbA1c، HDL, LDL, TG, FBS, BS 2pp, Cholesterol The primary outcome measure 3 months after intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015010720594N1
Registration date: 2016-04-14, 1395/01/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-14, 1395/01/26
Registrant information
Name
Monireh Mazandarani
Name of organization / entity
Shahrood Azad University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
nazemi1393@shu.ac.ir
Recruitment status
Recruitment complete
Funding source
Sponsor of this studying is an investigator
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The studdy effect of aquitic extract of Urtica dioica L. on Glycemic and and Lipidmic indexes in diabetic Patients
Public title
The Effect of Urtica dioica L. On Glucose and Lipid Indexes in Diabetic Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : age over 30 years; HbA1c less than 10 %; the most common diabetes medications ( Metformin ،Glibenclamide ) Exclusion criteria : a history of cardiovascular disease; renal disease; infectious disease; liver disease; thyroid disease; allergies disease; angina disease; consumption of nonsteroidal antiinflammatory drugs (NSAIDs); consumption of warfarin; consumption of estrogen and progesterone drugs; smoking, consumption of dietary supplements; consumption of herbal decoction; pregnancy and lactation
Age
From 34 years old to 79 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahrood University of Medical Sciences and health services
Street address
Hafte-Tir Square , Central Building University of Medical Sciences and Health Services , Vice President of Research and Technology
City
Shahrood
Postal code
3614773955
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
930/37

Health conditions studied

1

Description of health condition studied
diabetic mellitus type2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
HbA1c
Timepoint
After three month
Method of measurement
Blood Sampling

2

Description
HDL
Timepoint
After three month
Method of measurement
Blood Sampling

3

Description
LDL
Timepoint
After three month
Method of measurement
Blood sampling

4

Description
TG
Timepoint
After three month
Method of measurement
Blood Sampling

5

Description
FBS
Timepoint
After three month
Method of measurement
Blood Sampling

6

Description
BS2pp
Timepoint
after three month
Method of measurement
blood sampling

7

Description
Cholesterol
Timepoint
After three month
Method of measurement
Blood Sampling

Secondary outcomes

1

Description
body mass index
Timepoint
The baseline
Method of measurement
Meter،Balance

2

Description
Systolic Blood Pressur
Timepoint
first and last Undertaking Study
Method of measurement
Barometer

3

Description
Dyastolic Blood Pressure
Timepoint
First and last Undertaking Study
Method of measurement
Barometer

Intervention groups

1

Description
The study of aqueous extract of nettle as a herbal medicine for three months is available to patients،So that three meals daily in divided 1 ml of the extract, half an hour before meals ,Within a month 100 cc of concentrated extract is used
Category
Treatment - Drugs

2

Description
Placebo intervention: natural lemon juice Dosage: daily divided in three doses of 1 cc How to use the drug: half an hour before meals eaten Course of medication intervention: Three months to the total amount of 300 cc
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hussein Shahrood Hospital Medical Center
Full name of responsible person
DR. Sepide Nazemi
Street address
Lane 28-meter Ayatollah Tohidi ,Imam Street. Shahrood City
City
Shahrood

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Imam Hussein Shahrood Hospital Medical Center
Full name of responsible person
DR.Sepide Nazemi
Street address
Lane 28-meter Ayatollah Tohidi ,Imam Street. Shahrood City
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Imam Hussein Shahrood Hospital Medical Center
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
Imam Hussein Shahrood Hospital Medical Center
Full name of responsible person
DR. Sepide Nazemi
Position
Internal medicine specialist
Other areas of specialty/work
Street address
Lane 28-meter Ayatollah Tohidi ,Imam Street. Shahrood City
City
Shahrood
Postal code
Phone
+233 2343000
Fax
Email
Nazemi1393@shu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam Hussein Shahrood Hospital Medical Center
Full name of responsible person
DR.Sepide Nazemi
Position
internal physician
Other areas of specialty/work
Street address
Lane 28-meter Ayatollah Tohidi ,Imam Street. Shahrood City
City
shahrood city
Postal code
Phone
+98 23 3234 3000
Fax
Email
Nazemi1393@shu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Imam Hussein Shahrood Hospital Medical Center
Full name of responsible person
Monireh Mazandarani
Position
Medical Student
Other areas of specialty/work
Street address
Lane 28-meter Ayatollah Tohidi ,Imam Street. Shahrood City
City
Shahrood
Postal code
Phone
Fax
Email
Dr.monireh87@yahoo.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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