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

April 11, 2023 updated by: Dr. Saeid Safiri, Tabriz University of Medical Sciences

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
    • AzarbayejaneShargi
      • Tabriz, AzarbayejaneShargi, Iran, Islamic Republic of, 5166614766
        • Imam Reza hospital and Clinic of Salamat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tabriz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 28, 2023

Primary Completion (Anticipated)

February 28, 2024

Study Completion (Anticipated)

February 28, 2025

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70746

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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