Type 2 Diabetes MellitusPhase 1NCT00422357
Effect of Urtica Dioica on Glycemic Control in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing Urtica Dioica (Tea bag) in people with Type 2 Diabetes Mellitus, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Urtica Dioica (Tea bag)
- How many people
- 56 participants
- Where
- 1 siteIran
- Study dates
- Jan 2007to Apr 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of T2DM
- Must be able to drink UD or Placebo tea bags 3 times every day
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Urtica Dioica (Tea bag)
- Keywords
- Type 2 Diabetes Mellitus, Urtica Dioica (or stinging nettle), Hypoglycemic agents
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urtica Dioica (Tea bag)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startJan 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 56 participants
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Reza Rastmanesh, Ph.D., Study chair, Shahid Beheshti University of Medical SciencesNavid Saadat, MD, Study director, Shaheed Beheshti Medical Univrsity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422357
- Sponsor's protocol ID
- NNFTRI-1385
- Status last verified
- Apr 2007
- First submitted
- 12 Jan 2007
- Last updated
- 18 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Urtica Dioica on Glycemic Control in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00422357
- Acronym / sponsor ID
- NNFTRI-1385
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Urtica Dioica (or stinging nettle), Hypoglycemic agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of T2DM
- Must be able to drink UD or Placebo tea bags 3 times every day
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urtica Dioica (Tea bag) | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Rastmanesh, Ph.D. study chair
Shahid Beheshti University of Medical Sciences
Navid Saadat, MD study director
Shaheed Beheshti Medical Univrsity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Urtica Dioica (Tea bag) in people with Type 2 Diabetes Mellitus, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose every two weeks.. The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2007.