A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS)
研究概览
简要总结
A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)
详细描述
Charged by the sponsor in line with traditional Chinese medicine Qi deficiency and blood stasis syndrome 60 cases have DPN，they were randomly divided into Chinese herbal compound Xuebi prescription group and placebo group. The treatment groups were compared 24-week composite score.
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •did not meet the inclusion criteria, or incomplete information affect the clinical syndrome differentiation type;
- •repeated hypoglycemia reaction, nearly a month diabetic ketoacidosis, DKAand severe infections;
- •blood pressure without control or after control, SBP ≥ 160mmHg or (and)DBP ≥ 100mmHg;
- •TG≥ 5.6mmol / L;
- •diabetic lower extremity vascular disease (resting ankle brachial index in patients with ABI ≤ 0.90 or lower extremity ultrasound vascular stenosis > 50%).
- •pregnancy, to pregnant or lactating women;
- •the ingredients allergy of Chinese herbal medicine and allergic constitution person;
- •psychiatric patients;
- •have serious heart, lung, liver, kidney, brain and other complications overassociated with other severe primary diseases;
- •other patients had participated in clinical trials or are in other clinical trials before the test in January;
- •in the past 5 years with alcohol and / or psychoactive substances, drug abuse and dependence;
- •according to the researcher's judgment, can reduce the possibility of the group or other diseases or conditions were complicated, such as work environment change frequently, the living environment is not stable, easy to cause lost
- •hepatic, renal impairment (ALT, AST is greater than 2.5 times the upper limit of normal value; serum creatinine greater than 1.5 times the upper limit of normal value);
- •demyelinating lesions or from other causes of polyneuropathy patients.
研究组 & 干预措施
Xuebi formula
Xuebi formula , one dosage ,every day, treat 6 months.
干预措施: Xuebi formula (Drug)
Placebo
placebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months.
干预措施: placebo (Drug)
结局指标
主要结局
Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS)
时间窗: 24weeks
1. Scores of TCM clinical symptom. Using statistical table score, main symptoms and secondary symptoms according to the degree is divided into light, medium, heavy, the main symptoms were recorded 2, 4, 6 points, the secondary symptoms were recorded 1, 2, 3 points. No symptomatic record 0 points. Before the study, of 4, 8, 12, 16, 20, 24 week each recorded 1 times. Description of tongue and pulse only, not scoring. 2. the clinical scoring system of Toronto (TCSS). TCSS includes a score of neural symptoms, nerve reflex scores and sensory examination , a total of 19 points.Before the study, of 4, 8, 12, 16, 20, 24 week each scoring 1 times.According to the classification standard, 0-5 points does not have DPN, 6-8 points for mild DPN, 9-11 points for moderate DPN, 12-19 points for severe DPN.
次要结局
- Change in Nerve conduction velocity(24Weeks)
研究者
Fengmei Lian
chair
Guang'anmen Hospital of China Academy of Chinese Medical Sciences