跳至主要内容
临床试验/NCT05095922
NCT05095922已完成4 期

Effect of Heart-Protecting Musk Pill on Diabetic Microangiopaemia in Type 2 Diabetes Patients

Affiliated Hospital of Nantong University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Concentration of Serum fatty acid binding protein 4

研究概览

简要总结

The study mainly investigates the therapeutic effect of Heart-Protecting Musk Pill (HMP) on patients with diabetic microangiopathy. According to the indicators of diabetic nephropathy (DN), diabetic retinopathy (DR), oxidative stress and inflammatory factor in patients with diabetic microvascular disease after using HMP, the investigators aim to evaluate the effect of HMP on diabetic microangiopathy, oxidative stress and inflammation.

详细描述

Diabetes can lead to many diseases as diabetic macrovascular and microvascular complications which result in high disability and mortality rate, thereby seriously affecting the quality of life and life expectancy of diabetic patients. It not only aggravates the family burden of patients, but also becomes the main burden of public health services around the world.

Diabetic nephropathy (DN) and diabetic retinopathy (DR) are more serious in diabetic microangiopathy. The glomerulus and retina have the similar tissue structure and physiological function. Therefore, when they are exposured to the same risk factors can lead to microcirculation damage of kidney and retina. DN and DR have similar pathogenesis and development processes. Although the susceptibility genes and cytokines of DN and DR are different, the two can still be predictors of each other and they often coexist in diabetic patients.

At present, there are few drugs with definite curative effect on the treatment of diabetic microangiopathy, therefore the treatment of diabetic microangiopathy is an aspect that urgently needs a breakthrough in chronic complications of diabetes. Traditional Chinese medicine has a history of preventing and treating diabetes for thousands of years. For the treatment of chronic complications of diabetes by Chinese medicine, although there are not many Chinese medicines that have obtained curative effects, it has indeed accumulated rich experience in the process of research and clinical treatment that Western medicine could not obtain. Therefore, seeking Chinese medicine to effectively treat diabetic microvascular disease has become a direction worthy of attention and research.

Heart-Protecting Musk Pill (HMP) is a commonly used drug in clinical treatment, which comprises seven medicinal substances: Radix Ginseng, Venenum Bufonis, Styrax, Calculus Bovis Artifactus, Cortex Cinnamomi, Borneolum Syntheticum and Artificial Moschus. HMP is a traditional Chinese medicinal compound, which has been effectively used for treating coronary heart disease (CHD) and diabetic macrovascular disease. However, studies on Chinese medicines that are partially similar to HMP have shown that they can improve diabetic retinopathy. Therefore, the study of the efficacy of HMP on diabetic microangiopathy is extremely valuable. Previous researches have shown that HMP owns the effects of reducing oxidative stress, improving inflammation, anti-plateleting aggregation, promoting plasmin activity, and improving hemodynamics. It is possible that HMP can delay or improve the occurrence and development of diabetic microangiopathy through the above effects and even other unclear mechanisms.

At present, the drugs used for clinical treatment of type 2 diabetic microangiopathy are limited. Although the pharmacological indications of HMP can be used to deal with the pathogenesis of diabetic microvascular complications, there is still no clinical study of HMP for the treatment of diabetic microvascular complications. Therefore, this study compared the differences in indicators related to diabetic nephropathy, diabetic retinopathy, oxidative stress, and inflammatory factors between the control group and the HMP group before and after treatment to clarify the therapeutic effect of HMP on diabetic microangiopaemia.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Diabetes mellitus
  • Prescribed for Valsartan Capsules and Calcium Dobesilate Capsules

排除标准

  • Type 1 diabetes mellitus
  • Secondary diabetes
  • Malignant tumors
  • Active infection
  • Acute diabetic complications
  • Macrovascular complications
  • Mental illness
  • Intellectual disability
  • Impaired heart function
  • Impaired liver function
  • Impaired kidney function

研究组 & 干预措施

Heart-Protecting Musk Pill group

Experimental

Heart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months)+Valsartan Capsules(capsule, 80mg, once a day, 3 months)+Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)

干预措施: Heart-Protecting Musk Pill (Drug)

Heart-Protecting Musk Pill group

Experimental

Heart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months)+Valsartan Capsules(capsule, 80mg, once a day, 3 months)+Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)

干预措施: Valsartan Capsules (Drug)

Heart-Protecting Musk Pill group

Experimental

Heart-Protecting Musk Pill (pill, 45mg, three times a day, 3 months)+Valsartan Capsules(capsule, 80mg, once a day, 3 months)+Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)

干预措施: Calcium Dobesilate Capsules (Drug)

Control group

Placebo Comparator

Valsartan Capsules(capsule, 80mg, once a day, 3 months), Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)

干预措施: Valsartan Capsules (Drug)

Control group

Placebo Comparator

Valsartan Capsules(capsule, 80mg, once a day, 3 months), Calcium Dobesilate Capsules (capsule, 500mg, three times a day, 3 months)

干预措施: Calcium Dobesilate Capsules (Drug)

结局指标

主要结局

Concentration of Serum fatty acid binding protein 4

时间窗: Change from Baseline FABP4 at 3 months

Serum fatty acid binding protein 4(FABP4)

Concentration of Oxidative stress indicator

时间窗: Change from Baseline ROS at 3 months

Reactive oxygen species(ROS)

Concentration of biochemical Indicators

时间窗: Change from Baseline TC, TG, HDL-C, LDL-C, FBG, BUN at 3 months

Total cholesterol(TC), Triglycerides(TG), High-density lipoprotein cholesterol(HDL-C), Low-density lipoprotein cholesterol(LDL-C), Fasting blood glucose(FBG), Blood urea nitrogen(BUN)

Concentration of Serum creatinine

时间窗: Change from Baseline Scr at 3 months

Serum creatinine(Scr)

Indicators of diabetic retinopathy

时间窗: Change from Baseline effect at 3 months

The vision and fundus photography will be checked by an ophthalmologist to determine the effect.

Concentration of hypersensitive-c-reactive-protein and Cystatin C

时间窗: Change from Baseline hs-CRP and CysC at 3 months

hypersensitive-c-reactive-protein(hs-CRP), Cystatin C(CysC)

Concentration of inflammation indicator

时间窗: Change from Baseline CCL3 at 3 months

CC chemokine ligand 3(CCL3)

Rate of estimated Glomerular Filtration

时间窗: Change from Baseline eGFR at 3 months

estimated Glomerular Filtration Rate(eGFR)

Clinical characteristics

时间窗: Change from Baseline Height, Waistline at 3 months

Height, Waistline

Concentration of Glycosylated hemoglobin

时间窗: Change from Baseline HbA1c at 3 months

Glycosylated hemoglobin(HbA1c)

Ratio of Urinary albumin to creatinine

时间窗: Change from Baseline UACR at 3 months

Urinary albumin to creatinine Ratio(UACR)

Blood pressure

时间窗: Change from Baseline SBP, DBP at 3 months

Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP)

Clinical characteristic

时间窗: Change from Baseline Weight at 3 months

Weight

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验