Dog-rose, Cranberry Leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica and Sumac in Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Combination Product: Capsules containing the combination products
* Drug: Placebo capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Capsules containing the combination products<br>Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac | Combination Product: Capsules containing the combination products<br>* Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac<br>|
| Placebo Comparator: Placebo<br>Placebo capsules containing maltodextrin | Drug: Placebo capsules<br>* Placebo capsules containing maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose | Change in fasting blood glucose in response to intervention | Day 0, 15, 90, 180 post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin level | Change in insulin level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Hemoglobin A1c level | Change in hemoglobin A1c level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| High density lipoprotein (HDL) level | Change in high density lipoprotein (HDL) level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Low density lipoprotein (LDL) level | Change in low density lipoprotein (LDL) level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Triglyceride level | Change in triglyceride level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Total cholesterol level | Change in total cholesterol level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Aspartate transaminase level | Change in aspartate transaminase level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Alanine aminotransferase level | Change in alanine aminotransferase level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Blood urea nitrogen level | Change in blood urea nitrogen level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Creatinine level | Change in creatinine level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Prothrombin time | Change in prothrombin time in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Bilirubin level | Change in bilirubin level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Ferritin level | Change in ferritin level in response to intervention | Day 0, 15, 90, 180 post intervention | 
| Cholinesterase level | Change in cholinesterase level in response to intervention | 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 | Day 0, 15, 90, 180 post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urtica dioica, Type 2 diabetes, Insulin resistance, Lipochromin, Vaccinium macrocarpon, Medicago sativa, Trigonella, Fenugreek, Lemon Beebrush, Rhus, Sumac