Effect of Urtica Dioica on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Urtica Dioica (Tea bag)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Urtica Dioica (or stinging nettle), Hypoglycemic agents
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of T2DM
- Must be able to drink UD or Placebo tea bags 3 times every day
Exclusion Criteria:
- Insulin dependent diabetes
- History of congestive heart failure within last 5 years (NYHA Class III-IV)
- History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year
- Thyroid disease
- Known renal or hepatic insufficiency
- Gastric problem
- History of UD or and other herb use in past 6 months
- Pregnancy or lactation
- Use of any herbal or supplement within past 6 months
- Use of an investigational drug (within 30 days prior to enrollment)
- Known maternal allergies
- Dumping syndrome
Sites / Locations
- Primary Health Care Office
Outcomes
Primary Outcome Measures
Fasting blood glucose every two weeks.
Post prandial blood glucose every two weeks.
Fasting insulin every two weeks.
Insulin sensitivity as Quantitative Insulin Sensitivity Check Index (QUIKI) every two weeks.
C-Peptide every two weeks.
HBA1C every two weeks.
Serum lipids every two weeks.
Liver enzymes (ALT, AST) every two weeks.
GFR every two weeks.
Blood pressure every two weeks.
Secondary Outcome Measures
Full Information
NCT ID
NCT00422357
First Posted
January 12, 2007
Last Updated
April 17, 2007
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00422357
Brief Title
Effect of Urtica Dioica on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Official Title
Effect of Urtica Dioica on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Diabetes mellitus is the most common metabolic disorder worldwide. Some herbs are traditionally used in treatment of type 2 diabetes mellitus (T2DM). Urtica Dioica (UD) or stinging nettle is traditionally used in Morocco, Turkey, Brasil, Jordan and with much frequency in northern Iran.
Studies on animal models along with in vitro studies has shown hypoglycemic effect for aqueous extract of UD.
This study aimed to investigate hypoglycemic effects of UD tea bags in patients with T2DM on glycemic control, insulin sensitivity, along with its effects on lipid profile (LP), blood pressure (BP), liver, and kidney function.
Detailed Description
The study will be performed under randomized, double-blind, placebo controlled, and case-control design. The object of this study is patients with T2DM. Patients are randomly assigned to start with placebo tea bags (3 tea bags as 2-gram tea bag steamed in boiling water for 20 minutes: mixture of bran powder which is already boiled in water twice plus spinach powder) in control groups and UD tea bags (3 tea bags as 2-gram tea bag steamed in boiling water for 20 minutes) in patients with T2DM for two months. Every two weeks, fasting glucose, postprandial glucose after a standard breakfast, serum insulin, lipids, alanine amino transferase (ALT), aspartate amino transferase (AST), creatinine (to calculate GFR), along with blood pressure will be measured.
To the best of our knowledge, this is the first Randomized Clinical Trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Urtica Dioica (or stinging nettle), Hypoglycemic agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
56 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Urtica Dioica (Tea bag)
Primary Outcome Measure Information:
Title
Fasting blood glucose every two weeks.
Title
Post prandial blood glucose every two weeks.
Title
Fasting insulin every two weeks.
Title
Insulin sensitivity as Quantitative Insulin Sensitivity Check Index (QUIKI) every two weeks.
Title
C-Peptide every two weeks.
Title
HBA1C every two weeks.
Title
Serum lipids every two weeks.
Title
Liver enzymes (ALT, AST) every two weeks.
Title
GFR every two weeks.
Title
Blood pressure every two weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of T2DM
Must be able to drink UD or Placebo tea bags 3 times every day
Exclusion Criteria:
Insulin dependent diabetes
History of congestive heart failure within last 5 years (NYHA Class III-IV)
History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year
Thyroid disease
Known renal or hepatic insufficiency
Gastric problem
History of UD or and other herb use in past 6 months
Pregnancy or lactation
Use of any herbal or supplement within past 6 months
Use of an investigational drug (within 30 days prior to enrollment)
Known maternal allergies
Dumping syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Rastmanesh, Ph.D.
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Navid Saadat, MD
Organizational Affiliation
Shaheed Beheshti Medical Univrsity
Official's Role
Study Director
Facility Information:
Facility Name
Primary Health Care Office
City
Mahmood-Abaad
State/Province
Mazandaran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Urtica Dioica on Glycemic Control in Patients With Type 2 Diabetes Mellitus
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