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

NCT00422357 | Completed Phase 1 DMC

• 1 other identifier: NNFTRI-1385
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Urtica Dioica (or stinging nettle); Hypoglycemic agents

Outcome Measures

Primary Outcomes (10)

• 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.

Interventions

Urtica Dioica (Tea bag) DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of T2DM
• Must be able to drink UD or Placebo tea bags 3 times every day

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Primary Health Care Office

Mahmood-Abaad, Mazandaran, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Reza Rastmanesh, Ph.D.

  Shahid Beheshti University of Medical Sciences

  STUDY CHAIR

• Navid Saadat, MD

  Shaheed Beheshti Medical Univrsity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 15, 2007
• Study Start: January 1, 2007
• Study Completion: April 1, 2007
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

IR (1)