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

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ClinicalTrials.gov Identifier: NCT00422357
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : April 18, 2007
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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  (Clinical Trial)
Estimated Enrollment : 56 participants
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 : January 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Fasting blood glucose every two weeks.
  2. Post prandial blood glucose every two weeks.
  3. Fasting insulin every two weeks.
  4. Insulin sensitivity as Quantitative Insulin Sensitivity Check Index (QUIKI) every two weeks.
  5. C-Peptide every two weeks.
  6. HBA1C every two weeks.
  7. Serum lipids every two weeks.
  8. Liver enzymes (ALT, AST) every two weeks.
  9. GFR every two weeks.
  10. Blood pressure every two weeks.

Eligibility Criteria

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422357

Iran, Islamic Republic of
Primary Health Care Office
Mahmood-Abaad, Mazandaran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Study Chair: Reza Rastmanesh, Ph.D. Shahid Beheshti University of Medical Sciences
Study Director: Navid Saadat, MD Shaheed Beheshti Medical Univrsity
More Information

ClinicalTrials.gov Identifier: NCT00422357     History of Changes
Other Study ID Numbers: NNFTRI-1385
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:
Type 2 Diabetes Mellitus
Urtica Dioica (or stinging nettle)
Hypoglycemic agents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases