NCT05700513

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tabriz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-28
• Primary completion: 2024-02-28
• Completion: 2025-02-28
• First posted: 2023-01-26
• Last updated: 2023-04-14

Locations

1 site across 1 country: Iran