Effect of Urtica Dioica on Glycemic Control in Patients With Type 2 Diabetes Mellitus

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00422357

Collaborator

(none)

Enrollment

Location

Duration (Months)

18.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Urtica Dioica (Tea bag)	Phase 1

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Effect of Urtica Dioica on Glycemic Control in Patients With Type 2 Diabetes Mellitus

Study Start Date :

Jan 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary Health Care Office	Mahmood-Abaad	Mazandaran	Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

Study Chair: Reza Rastmanesh, Ph.D., Shahid Beheshti University of Medical Sciences
Study Director: Navid Saadat, MD, Shaheed Beheshti Medical Univrsity