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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-04-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Urtica Dioica (Tea bag)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Reza Rastmanesh, Ph.D.

Role: STUDY_CHAIR

Shahid Beheshti University of Medical Sciences

Navid Saadat, MD

Role: STUDY_DIRECTOR

Shaheed Beheshti Medical Univrsity

Locations

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Primary Health Care Office

Mahmood-Abaad, Mazandaran, Iran

Site Status

Countries

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Iran

Other Identifiers

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NNFTRI-1385

Identifier Type: -

Identifier Source: org_study_id