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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00422357
First received: January 12, 2007
Last updated: April 17, 2007
Last verified: April 2007
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: Urtica Dioica (Tea bag)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Urtica Dioica on Glycemic Control in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

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.

Estimated Enrollment: 56
Study Start Date: January 2007
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422357

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

No publications provided

ClinicalTrials.gov Identifier: NCT00422357     History of Changes
Other Study ID Numbers: NNFTRI-1385
Study First Received: January 12, 2007
Last Updated: April 17, 2007
Health Authority: Iran: Ministry of Health

Keywords provided by Shahid Beheshti Medical University:
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

ClinicalTrials.gov processed this record on September 30, 2014