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NCT Number: NCT00422357

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Primary Health Care Office

Mahmood-Abaad, Mazandaran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urtica Dioica (Tea bag)

Drug

Primary outcomes

  1. Fasting blood glucose every two weeks.

  2. Post prandial blood glucose every two weeks.

  3. Fasting insulin every two weeks.

  4. Insulin sensitivity as Quantitative Insulin Sensitivity Check Index (QUIKI) every two weeks.

  5. C-Peptide every two weeks.

  6. HBA1C every two weeks.

  7. Serum lipids every two weeks.

  8. Liver enzymes (ALT, AST) every two weeks.

  9. GFR every two weeks.

  10. Blood pressure every two weeks.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start
2007
Study completion
2007
First posted
Jan 15, 2007
Registry last updated
Apr 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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