Type 2 DiabetesPhase 1/2NCT05700513
Dog-rose, Cranberry Leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica and Sumac in Diabetes Mellitus
A Phase 1/2 study testing Capsules containing the combination products in people with Type 2 Diabetes, run by Tabriz University of Medical Sciences at 1 site in Iran.
Trial summary
This study investigates the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving the glycemic profile of patients with type 2 diabetes mellitus compared to the placebo group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Capsules containing the combination products
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 28 Jul 2023to 28 Feb 2025
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one year of diagnosis of type 2 diabetes according to the criteria of the World Health Organization,
- Hemoglobin A1c (HbA1c) > 7.0% or fasting blood glucose > 7.0 mmol/L,
- Body mass index (BMI) more than 23 kg/m2 and less than 35.
Who cannot join
- Comorbidities, including type 1 diabetes, cardiovascular disease, thyroid disease, liver disease, kidney disease, cancer, mental disorders, and the use of drugs related to the aforementioned diseases,
- Pregnancy,
- Patients with a BMI over 35 who were on a weight loss diet or had taken weight loss supplements for less than 6 months
- A history of allergy to one of the components of the nestling fruit, carob leaf, carob fruit, alfalfa seed, fenugreek seed, lemon, Nettles and sumac and also
- Lactating women
- Regularly consuming cigarettes or alcohol
- Using psychiatric drugs or insulin
- Changing in the medication regimen during the trial period. For example, to start receiving insulin therapy, become pregnant, or no longer follow medication and dietary instructions.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Imam Reza hospital and clinic of Salamat
Tabriz, AzarbayejaneShargi, 5166614766
About this study
Official title: The Joint Effects of Dog-rose, Cranberry Leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac for Controlling Blood Glucose of Patients With Type II Diabetes Mellitus: A Phase 1-2 Randomized Placebo-Controlled Trial
This study investigates the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving the glycemic profile of patients with type 2 diabetes mellitus compared to the placebo group.
Read the detailed description
The present double-blind, randomized and placebo-controlled study will be conducted on type 2 diabetes mellitus patients to evaluate the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving glycemic profiles (fasting blood sugar, glycosylated Hemoglobin, 2 hours postprandial blood sugar, insulin concentration, insulin resistance, and beta-cell function). The study also evaluates systolic blood pressure, diastolic blood pressure, anthropometric variables, lipid profile, C-reactive protein, and renal and liver function tests.
A pilot study with 30 participants will be conducted to estimate the sample size considering 0.05 first type error and a power of 80%. Individuals aged between 18-70 with a diagnosis of type 2 diabetes mellitus based on WHO criteria for at least one year will be enrolled. Participants will be randomized in the placebo or intervention group to receive two capsules per day before lunch and dinner for six months containing 200 milligrams of equally combined extracts of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac. Participants will be followed up with four office visits (t0= baseline, 1=15th day, 2t=3rd month, 3t=6th month) to assess outcomes. Also, the complications and adherence of patients to intervention will be checked every two weeks by telephonic discussion. The analysis will be performed based on the intent-to-treat method.
- Conditions
- Type 2 Diabetes
- Being tested
- Capsules containing the combination products, Placebo capsules
- Keywords
- Type 2 diabetes, Insulin resistance, Lipochromin, Vaccinium macrocarpon, Medicago sativa, Trigonella, Fenugreek, Lemon Beebrush, Urtica dioica, Rhus, Sumac
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsules containing the combination productsCombination product
Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac
Placebo capsulesDrug
Placebo capsules containing maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Capsules containing the combination products | Active comparator | Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac Receives: Combination Product: Capsules containing the combination products |
| Placebo | Placebo comparator | Placebo capsules containing maltodextrin Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
Change in fasting blood glucose in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Secondary outcomes (15)
Insulin level
Change in insulin level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Hemoglobin A1c level
Change in hemoglobin A1c level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
High density lipoprotein (HDL) level
Change in high density lipoprotein (HDL) level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Low density lipoprotein (LDL) level
Change in low density lipoprotein (LDL) level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Triglyceride level
Change in triglyceride level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Total cholesterol level
Change in total cholesterol level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Aspartate transaminase level
Change in aspartate transaminase level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Alanine aminotransferase level
Change in alanine aminotransferase level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Blood urea nitrogen level
Change in blood urea nitrogen level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Creatinine level
Change in creatinine level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Prothrombin time
Change in prothrombin time in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Bilirubin level
Change in bilirubin level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Ferritin level
Change in ferritin level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Cholinesterase level
Change in cholinesterase level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
High-sensitivity C-reactive protein level
Change in high-sensitivity C-reactive protein level in response to intervention
Measured: Day 0, 15, 90, 180 post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start28 Jul 2023 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabriz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Saeid Safiri, Tabriz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700513
- Sponsor's protocol ID
- 70746
- Status last verified
- Apr 2023
- First submitted
- 17 Jan 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Joint Effects of Dog-rose, Cranberry Leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac for Controlling Blood Glucose of Patients With Type II Diabetes Mellitus: A Phase 1-2 Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05700513
- Acronym / sponsor ID
- 70746
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Insulin resistance, Lipochromin, Vaccinium macrocarpon, Medicago sativa, Trigonella, Fenugreek, Lemon Beebrush
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tabriz University of Medical SciencesUniversity, hospital or other
- Study start
- 28 Jul 2023 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 26 Jan 2023 (actual)
- 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.
This study investigates the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving the glycemic profile of patients with type 2 diabetes mellitus compared to the placebo group.
Detailed description
The present double-blind, randomized and placebo-controlled study will be conducted on type 2 diabetes mellitus patients to evaluate the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving glycemic profiles (fasting blood sugar, glycosylated Hemoglobin, 2 hours postprandial blood sugar, insulin concentration, insulin resistance, and beta-cell function). The study also evaluates systolic blood pressure, diastolic blood pressure, anthropometric variables, lipid profile, C-reactive protein, and renal and liver function tests.
A pilot study with 30 participants will be conducted to estimate the sample size considering 0.05 first type error and a power of 80%. Individuals aged between 18-70 with a diagnosis of type 2 diabetes mellitus based on WHO criteria for at least one year will be enrolled. Participants will be randomized in the placebo or intervention group to receive two capsules per day before lunch and dinner for six months containing 200 milligrams of equally combined extracts of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac. Participants will be followed up with four office visits (t0= baseline, 1=15th day, 2t=3rd month, 3t=6th month) to assess outcomes. Also, the complications and adherence of patients to intervention will be checked every two weeks by telephonic discussion. The analysis will be performed based on the intent-to-treat method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsules containing the combination products | Active comparator | Combination Product: Capsules containing the combination productsCapsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac |
| Placebo | Placebo comparator | Drug: Placebo capsulesPlacebo capsules containing maltodextrin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one year of diagnosis of type 2 diabetes according to the criteria of the World Health Organization,
- Hemoglobin A1c (HbA1c) > 7.0% or fasting blood glucose > 7.0 mmol/L,
- Body mass index (BMI) more than 23 kg/m2 and less than 35.
Key exclusion criteria (8 listed)
- Comorbidities, including type 1 diabetes, cardiovascular disease, thyroid disease, liver disease, kidney disease, cancer, mental disorders, and the use of drugs related to the aforementioned diseases,
- Pregnancy,
- Patients with a BMI over 35 who were on a weight loss diet or had taken weight loss supplements for less than 6 months
- A history of allergy to one of the components of the nestling fruit, carob leaf, carob fruit, alfalfa seed, fenugreek seed, lemon, Nettles and sumac and also
- Lactating women
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 |
|---|---|---|
| Capsules containing the combination productsCapsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac | Combination product | Capsules containing the combination products |
| Placebo capsulesPlacebo capsules containing maltodextrin | Drug | Placebo |
Primary outcome
Fasting blood glucose
Time frame: Day 0, 15, 90, 180 post intervention
Change in fasting blood glucose in response to intervention
15 secondary outcomes
Insulin level
Time frame: Day 0, 15, 90, 180 post intervention
Hemoglobin A1c level
Time frame: Day 0, 15, 90, 180 post intervention
High density lipoprotein (HDL) level
Time frame: Day 0, 15, 90, 180 post intervention
Low density lipoprotein (LDL) level
Time frame: Day 0, 15, 90, 180 post intervention
Triglyceride level
Time frame: Day 0, 15, 90, 180 post intervention
Total cholesterol level
Time frame: Day 0, 15, 90, 180 post intervention
Aspartate transaminase level
Time frame: Day 0, 15, 90, 180 post intervention
Alanine aminotransferase level
Time frame: Day 0, 15, 90, 180 post intervention
Blood urea nitrogen level
Time frame: Day 0, 15, 90, 180 post intervention
Creatinine level
Time frame: Day 0, 15, 90, 180 post intervention
Prothrombin time
Time frame: Day 0, 15, 90, 180 post intervention
Bilirubin level
Time frame: Day 0, 15, 90, 180 post intervention
Ferritin level
Time frame: Day 0, 15, 90, 180 post intervention
Cholinesterase level
Time frame: Day 0, 15, 90, 180 post intervention
High-sensitivity C-reactive protein level
Time frame: Day 0, 15, 90, 180 post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Capsules containing the combination products in people with Type 2 Diabetes, run by Tabriz 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saeid Safiri, PhD (+984133342178, saeidsafiri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (time frame: Day 0, 15, 90, 180 post intervention). 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 14 Apr 2023.