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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05700513
• Other study ID #: 70746
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 28, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2023
• Source: Tabriz University of Medical Sciences
• Contact: Saeid Safiri, PhD
• Phone: +984133342178
• Email: saeidsafiri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Combination Product:
• Capsules containing the combination products
Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac

Drug:
• Placebo capsules
Placebo capsules containing maltodextrin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Reza hospital and clinic of Salamat	Tabriz	AzarbayejaneShargi

Sponsors (1)

Lead Sponsor	Collaborator
Tabriz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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