NCT05700513

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Jul 2023

Longer than P75 for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 28, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

January 17, 2023

Last Update Submit

April 11, 2023

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesInsulin resistanceLipochrominVaccinium macrocarponMedicago sativaTrigonellaFenugreekLemon BeebrushUrtica dioicaRhusSumac

Outcome Measures

Primary Outcomes (1)

  • Fasting blood glucose

    Change in fasting blood glucose in response to intervention

    Day 0, 15, 90, 180 post intervention

Secondary Outcomes (15)

  • Insulin level

    Day 0, 15, 90, 180 post intervention

  • Hemoglobin A1c level

    Day 0, 15, 90, 180 post intervention

  • High density lipoprotein (HDL) level

    Day 0, 15, 90, 180 post intervention

  • Low density lipoprotein (LDL) level

    Day 0, 15, 90, 180 post intervention

  • Triglyceride level

    Day 0, 15, 90, 180 post intervention

  • +10 more secondary outcomes

Study Arms (2)

Capsules containing the combination products

ACTIVE COMPARATOR

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

Combination Product: Capsules containing the combination products

Placebo

PLACEBO COMPARATOR

Placebo capsules containing maltodextrin

Drug: Placebo capsules

Interventions

Capsules containing the combination productsCOMBINATION_PRODUCT

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

Capsules containing the combination products
Placebo capsulesDRUG

Placebo capsules containing maltodextrin

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Reza hospital and clinic of Salamat

Tabriz, AzarbayejaneShargi, 5166614766, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Central Study Contacts

Saeid Safiri, PhD

CONTACT

+984133342178saeidsafiri@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

July 28, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2025

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

IR(1)