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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fasting blood glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Capsules containing the combination products
Capsules containing dog-rose, Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, and Sumac
干预措施: Capsules containing the combination products (Combination Product)
Placebo
Placebo capsules containing maltodextrin
干预措施: Placebo capsules (Drug)
结局指标
主要结局
Fasting blood glucose
时间窗: Day 0, 15, 90, 180 post intervention
Change in fasting blood glucose in response to intervention
次要结局
- Creatinine level(Day 0, 15, 90, 180 post intervention)
- Prothrombin time(Day 0, 15, 90, 180 post intervention)
- 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)
- Total cholesterol level(Day 0, 15, 90, 180 post intervention)
- Aspartate transaminase level(Day 0, 15, 90, 180 post intervention)
- Alanine aminotransferase level(Day 0, 15, 90, 180 post intervention)
- Blood urea nitrogen level(Day 0, 15, 90, 180 post intervention)
- Bilirubin level(Day 0, 15, 90, 180 post intervention)
- Ferritin level(Day 0, 15, 90, 180 post intervention)
- Cholinesterase level(Day 0, 15, 90, 180 post intervention)
- High-sensitivity C-reactive protein level(Day 0, 15, 90, 180 post intervention)
研究者
Dr. Saeid Safiri
Principal Investigator
Tabriz University of Medical Sciences