Improvement of Ankle-Brachial Index by DLBS1033 Treatment in Diabetic Patients With Peripheral Arterial Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Resting ankle-brachial index (ABI)
研究概览
简要总结
This is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 for the improvement of ankle-brachial index in diabetic patients with peripheral arterial disease (PAD). It is hypothesized that the addition of DLBS1033 on top of aspirin treatment will augment significantly the resting ABI in diabetes patient with PAD in comparison with that of aspirin alone.
详细描述
Subjects in this study will be screened consecutively and eligible subjects will be randomized to receive aspirin tablet 80 mg once daily and either the investigational drug (DLBS1033 tablet 490 mg three times daily) or its placebo, for 12 weeks.
Diabetic subjects who have been being under therapy with aspirin can directly start with study treatment. For those who are currently not under therapy with aspirin, there will be a run-in period during which they will receive (or be switched to) aspirin treatment, for two weeks. After then, they will receive study medication.
Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at the interval of six weeks over the twelve week-course of therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent before any trial related activities.
- •Male or female subjects of 40 - 65 years of age.
- •Diagnosis of diabetes mellitus defined as HbA1c level of ≥ 6.5% (for newly diagnosed diabetes) or based on medical history.
- •Presence of peripheral arterial disease with resting ankle-brachial index (ABI) of 0.41-0.90 inclusive
排除标准
- •Females of childbearing potential: pregnancy, breast-feeding, and the intention of becoming pregnant.
- •Recent stroke attack, myocardial infarction/unstable angina/acute coronary syndrome, coronary artery bypass surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA)/stent within 3 (three) months prior to screening.
- •Impaired liver function: serum ALT > 2.5 times upper limit of normal.
- •Impaired renal function: serum creatinine ≥ 1.5 times upper limit of normal.
- •Concomitant use of other antithrombosis drugs or any antiplatelets other than the study medication.
- •Subjects with concurrent herbal (alternative) medicines or food supplements
- •Subjects with any other disease state, including chronic or acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation.
- •Subjects with high risk of bleeding:
- •Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.
- •Subjects with known or suspected allergy to any of study medications used in the study, including other lumbrokinase products.
- •Subjects with known or suspected allergy or resistant to aspirin.
研究组 & 干预措施
DLBS1033
DLBS1033 tablet is administered at the dose of 490 mg, one tablet three times daily, every day for twelve weeks of study period
干预措施: DLBS1033 (Drug)
Placebo
Placebo tablet is administered one tablet three times daily, every day for twelve weeks of study period
干预措施: Placebo (Drug)
结局指标
主要结局
Resting ankle-brachial index (ABI)
时间窗: Week 0 and 12
The change of resting ABI
次要结局
- Resting ABI(Week 0 and 6)
- Thromboxane B2(Week 0, 6, and 12)
- d-dimer(Week 0, 6, and 12)
- Liver function(Week 0 and 12)
- Renal function(Week 0 and 12)
- hs-CRP(Week 0, 6, and 12)
- Adverse events(Week 0 - 12)
- Fibrinogen(Week 0, 6, and 12)
- Routine hematology(Week 0, 6, and 12)
- Haemostasis parameters(Week 0, 6, and 12)