DRKS00031074已完成2 期
Efficacy and tolerability of horse chestnut seed extract to improve microcirculation in diabetic patients: a placebo-controlled, randomised, double-blind, crossover, single-centre, pilot study - CES_AES_02/21
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Subjects of any sex (at least 25% men or women)
- •Willing to provide personally written informed consent
- •At least 18 years of age at time of consent
- •Willing and able to understand the nature, significance and consequences of the clinical trial
- •have type 2 diabetes with stable anti-diabetic treatment (no change in dose or composition over the last three months)
- •have a stable treatment for all concomitant diseases (no change in dose or composition over the last three months)
排除标准
- •Body Mass Index (BMI) >35 kg/m²
- •HbA1C >7.5%
- •Subjects who have participated in an interventional clinical research study within the previous 3 months.
- •Subjects who are taking bolus-insulin or sulfonylurea drugs as anti-diabetic medication or PII treatment within the previous 3 months.
- •Subjects with regular or occasional intake of herbal vasoactive drugs (e.g. HCSE, Ginkgo, Ginseng, red wine leaves, diosmin/hesperidin)
- •Subjects with occasional intake of vasodilating drugs (Nitrates, ACE-inhibitors, alpha-blockers, phosphodiesterase inhibitors, Ca-antagonists, Minoxidil, Dihydralazin, Dihydroergotoxin, Pentoxifylin) or acetylsalicylic acid > 100 mg/d
- •Subjects with occasional intake of vasoconstrictors (caffeine tablets, amphetamine, alpha-1-agonists, dopamine, ephedrine, norephedrine)
- •Manifest neuropathy
- •Pregnant or breast-feeding women
- •Severe disease with expected life expectancy less than 2 years or at the investigator’s discretion
- •Study site employees, or immediate family members of a study site or sponsor employee.
- •Subjects with symptomatic malabsorption disorders (Crohn’s Disease, Colitis ulcerosa, lactose or gluten intolerance)
- •Subjects with rheumatoid disorders
- •Weight loss intervention or recent body weight change greater than 5 kg during last 3 months
- •Known allergy to any component of the investigational product
- •Blood donation within 4 weeks prior to Visit 1 or during the study
- •Anticipating any planned changes in lifestyle and nutrition habits for the duration of the study
- •Clinical or laboratory evidence of hepatic or renal dysfunction or disease at investigator’s discretion; laboratory evidence defined as any of the following parameters: ALAT, ASAT >3x ULN; eGFR < 30 mg/min/1.73 m2
- •Subjects who have previously been enrolled in this study.
- •Any subject who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures (e.g., cognitive impairment).
研究者
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