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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Navid Saadat, MD, Shaheed Beheshti Medical Univrsity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

January 12, 2007

First Submitted That Met QC Criteria

January 12, 2007

First Posted (ESTIMATE)

January 15, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 18, 2007

Last Update Submitted That Met QC Criteria

April 17, 2007

Last Verified

April 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Urtica Dioica (Tea bag)

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