Clinical trial NCT05700513: Dog-rose, Cranberry Leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica and Sumac in Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Insulin resistance
Lipochromin
Vaccinium macrocarpon
Medicago sativa
Trigonella
Fenugreek
Lemon Beebrush
Urtica dioica
Rhus
Sumac
Lead sponsor: Tabriz University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting blood glucose
timeFrame: Day 0, 15, 90, 180 post intervention
Secondary outcomes:
measure: Insulin level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Hemoglobin A1c level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: High density lipoprotein (HDL) level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Low density lipoprotein (LDL) level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Triglyceride level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Total cholesterol level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Aspartate transaminase level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Alanine aminotransferase level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Blood urea nitrogen level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Creatinine level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Prothrombin time
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Bilirubin level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Ferritin level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: Cholinesterase level
timeFrame: Day 0, 15, 90, 180 post intervention
measure: High-sensitivity C-reactive protein level
timeFrame: Day 0, 15, 90, 180 post intervention
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Imam Reza hospital and clinic of Salamat
state: AzarbayejaneShargi
Study officials:
References: