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

Tabriz University of Medical Sciences

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Type 2 Diabetes

Treatments: Combination Product: Capsules containing the combination products; Drug: Placebo capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT05700513

70746

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Capsules containing the combination products

Active Comparator group

Description:

Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac

Treatment:

Combination Product: Capsules containing the combination products

Placebo

Placebo Comparator group

Description:

Placebo capsules containing maltodextrin

Treatment:

Drug: Placebo capsules