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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422357
• Other study ID #: NNFTRI-1385
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2007
• Last updated: April 17, 2007
• Start date: January 2007
• Est. completion date: April 2007

Study information

• Verified date: April 2007
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Urtica Dioica (Tea bag)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Primary Health Care Office	Mahmood-Abaad	Mazandaran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood glucose every two weeks.
Primary	Post prandial blood glucose every two weeks.
Primary	Fasting insulin every two weeks.
Primary	Insulin sensitivity as Quantitative Insulin Sensitivity Check Index (QUIKI) every two weeks.
Primary	C-Peptide every two weeks.
Primary	HBA1C every two weeks.
Primary	Serum lipids every two weeks.
Primary	Liver enzymes (ALT, AST) every two weeks.
Primary	GFR every two weeks.
Primary	Blood pressure every two weeks.